Support for healthy breastfeeding mothers with healthy term babies

  • Review
  • Intervention

Authors


Abstract

Background

There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended that infants be breastfed exclusively until six months of age, with breastfeeding continuing as an important part of the infant’s diet until at least two years of age. However, current breastfeeding rates in many countries do not reflect this recommendation.

Objectives

To describe forms of breastfeeding support which have been evaluated in controlled studies, the timing of the interventions and the settings in which they have been used.

To examine the effectiveness of different modes of offering similar supportive interventions (for example, whether the support offered was proactive or reactive, face-to-face or over the telephone), and whether interventions containing both antenatal and postnatal elements were more effective than those taking place in the postnatal period alone.

To examine the effectiveness of different care providers and (where information was available) training.

To explore the interaction between background breastfeeding rates and effectiveness of support.

Search methods

We searched Cochrane Pregnancy and Childbirth's Trials Register (29 February 2016) and reference lists of retrieved studies.

Selection criteria

Randomised or quasi-randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care.

Data collection and analysis

Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. The quality of the evidence was assessed using the GRADE approach.

Main results

This updated review includes 100 trials involving more than 83,246 mother-infant pairs of which 73 studies contribute data (58 individually-randomised trials and 15 cluster-randomised trials). We considered that the overall risk of bias of trials included in the review was mixed. Of the 31 new studies included in this update, 21 provided data for one or more of the primary outcomes. The total number of mother-infant pairs in the 73 studies that contributed data to this review is 74,656 (this total was 56,451 in the previous version of this review). The 73 studies were conducted in 29 countries. Results of the analyses continue to confirm that all forms of extra support analyzed together showed a decrease in cessation of 'any breastfeeding', which includes partial and exclusive breastfeeding (average risk ratio (RR) for stopping any breastfeeding before six months 0.91, 95% confidence interval (CI) 0.88 to 0.95; moderate-quality evidence, 51 studies) and for stopping breastfeeding before four to six weeks (average RR 0.87, 95% CI 0.80 to 0.95; moderate-quality evidence, 33 studies). All forms of extra support together also showed a decrease in cessation of exclusive breastfeeding at six months (average RR 0.88, 95% CI 0.85 to 0.92; moderate-quality evidence, 46 studies) and at four to six weeks (average RR 0.79, 95% CI 0.71 to 0.89; moderate quality, 32 studies). We downgraded evidence to moderate-quality due to very high heterogeneity.

We investigated substantial heterogeneity for all four outcomes with subgroup analyses for the following covariates: who delivered care, type of support, timing of support, background breastfeeding rate and number of postnatal contacts. Covariates were not able to explain heterogeneity in general. Though the interaction tests were significant for some analyses, we advise caution in the interpretation of results for subgroups due to the heterogeneity. Extra support by both lay and professionals had a positive impact on breastfeeding outcomes. Several factors may have also improved results for women practising exclusive breastfeeding, such as interventions delivered with a face-to-face component, high background initiation rates of breastfeeding, lay support, and a specific schedule of four to eight contacts. However, because within-group heterogeneity remained high for all of these analyses, we advise caution when making specific conclusions based on subgroup results. We noted no evidence for subgroup differences for the any breastfeeding outcomes.

Authors' conclusions

When breastfeeding support is offered to women, the duration and exclusivity of breastfeeding is increased. Characteristics of effective support include: that it is offered as standard by trained personnel during antenatal or postnatal care, that it includes ongoing scheduled visits so that women can predict when support will be available, and that it is tailored to the setting and the needs of the population group. Support is likely to be more effective in settings with high initiation rates. Support may be offered either by professional or lay/peer supporters, or a combination of both. Strategies that rely mainly on face-to-face support are more likely to succeed with women practising exclusive breastfeeding.

Résumé scientifique

Prise en charge des mères allaitantes en bonne santé avec des bébés nés à terme et en bonne santé

Contexte

Il existe des preuves probantes selon lesquelles l'absence d'allaitement expose la santé des nouveau-nés et des mères à des risques importants. En 2003, l'Organisation Mondiale de la Santé recommandait que les nouveau-nés soient exclusivement allaités jusqu'à l'âge de six mois avec poursuite de l'allaitement comme élément important du régime alimentaire du nouveau-né jusqu'à au moins l'âge de deux ans. Toutefois, à l'heure actuelle, les taux d'allaitement ne reflètent pas cette recommandation dans de nombreux pays.

Objectifs

Évaluer l'efficacité de la prise en charge des mères allaitantes.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre des essais du groupe Cochrane sur la grossesse et la naissance (3 octobre 2011).

Critères de sélection

Des essais contrôlés randomisés ou quasi randomisés comparant une prise en charge supplémentaire des mères allaitantes en bonne santé de bébés nés à terme et en bonne santé à des soins maternels standard.

Recueil et analyse des données

Deux auteurs de la revue ont indépendamment évalué la qualité méthodologique des essais et extrait des données.

Résultats principaux

Sur les 67 études que nous avons évaluées comme étant éligibles pour l'inclusion, 52 ont fourni des données de résultat pour cette revue (56 451 paires mère - nouveau-né) et provenaient de 21 pays différents. Toutes les formes de prise en charge supplémentaire analysées montraient une augmentation de la durée de l'allaitement quel qu'il soit (inclut l'allaitement partiel et exclusif) (risque relatif (RR) de l'arrêt de l'allaitement avant six mois 0,91, intervalle de confiance (IC) à 95 % 0,88 à 0,96). Toutes les formes de prise en charge supplémentaire avaient des effets positifs sur la durée de l'allaitement exclusif (RR à six mois 0,86, IC à 95 % 0,82 à 0,91 ; RR de quatre à six semaines 0,74, IC à 95 % 0,61 à 0,89). La prise en charge supplémentaire assurée par les aidants et les professionnels avait un effet positif sur les résultats liés à l'allaitement. La satisfaction maternelle était mal signalée.

Conclusions des auteurs

Toutes les femmes doivent pouvoir bénéficier d'une prise en charge pour allaiter leurs bébés afin d'augmenter la durée et l'exclusivité de l'allaitement. Cette prise en charge aura plus de chances d'être efficace dans des lieux où les taux d'initiation sont élevés. Des efforts visant à augmenter le recours à l'allaitement doivent donc être implantés. Un professionnel ou un aidant/collègue, ou une combinaison des deux, peut proposer cette prise en charge. Les stratégies reposant principalement sur une prise en charge face à face ont plus de chances de réussir. Une prise en charge qui est uniquement proposée de façon réactive, pour laquelle les femmes doivent initier le contact, a peu de chances d'être efficace ; les femmes doivent pouvoir bénéficier de visites permanentes et planifiées afin de prévoir la disponibilité de la prise en charge qui doit être adaptée aux besoins du lieu et du groupe de population.

Resumo

Apoio para mulheres saudáveis que amamentam bebês saudáveis nascidos a termo

Introdução

Existe muita evidência sobre os riscos que não amamentar pode trazer à saúde dos bebês e das mães. Em 2003, a Organização Mundial de Saúde recomendou o aleitamento materno exclusivo até os seis meses de idade e continuar a amamentar até os dois anos de idade, pois o leite materno é uma parte importante da dieta da criança até essa idade. Contudo, em muitos países, as taxas de amamentação atuais não refletem essa recomendação.

Objetivos

Descrever as formas de apoio à amamentação que foram avaliadas em estudos controlados, seu tempo, as intervenções e os locais onde foram aplicadas.

Avaliar a efetividade de diferentes formas de intervenções semelhantes para apoiar a amamentação (por exemplo, apoio proativo ou reativo, presencial ou via telefone). Avaliar se intervenções com componentes na gestação e após o nascimento são mais efetivas que intervenções com apenas um desses componentes.

Avaliar a efetividade de diferentes tipos de pessoas para apoiar a amamentação e (se existir essa informação) a efetividade do treinamento dessas pessoas.

Investigar a interação entre as taxas iniciais de amamentação e a efetividade do apoio à amamentação.

Métodos de busca

Fizemos buscas na Cochrane Pregnancy e Childbirth Group's Trials Register (29 de fevereiro de 2016) e nas listas de referências dos estudos incluídos.

Critério de seleção

Incluímos na revisão ensaios clínicos randomizados (ECR) ou quasi-randomizados que compararam apoio extra para mães saudáveis de bebês saudáveis nascidos a termo versus cuidados habituais.

Coleta dos dados e análises

Dois autores da revisão, trabalhando de forma independente, selecionaram os estudos a serem incluídos, extraíram os dados e verificaram a exatidão desse processo. Usamos o GRADE para avaliar a qualidade das evidências.

Principais resultados

Esta atualização da revisão incluiu 100 estudos, envolvendo mais de 83.246 pares de mãe-filho (58 ECRs e 15 ensaios clínicos do tipo cluster ou conglomerado). Em geral, o risco de viés dos estudos incluídos na revisão foi heterogêneo. Dentre os 31 novos estudos incluídos nesta atualização, 21 tinham dados sobre um ou mais dos desfechos primários. Esta versão envolve 74.656 pares mãe-filho, incluídos em 73 estudos com dados que puderam ser usados na revisão (na versão anterior desta revisão, eram 54.451 pares mãe-filho). Os 73 estudos foram realizados em 29 países. Os resultados das análises continuam confirmando que todas as formas de apoio adicional reduzem o risco de parar “qualquer tipo de amamentação” (amamentação exclusiva ou parcial). O risco relativo (RR) de interromper qualquer tipo de amamentação antes do sexto mês foi 0,91, com intervalo de confiança de 95% (IC95%) de 0,88 a 0,95, evidência de qualidade moderada, 51 estudos. O RR de interromper a amamentação antes de 4-6 semanas foi de 0,87, IC95% 0,80-0,95, evidência de qualidade moderada, 33 estudos.Todas as formas de apoio juntas reduziram o risco de interromper a amamentação exclusiva no sexto mês (RR 0,88, IC95% 0,85-0,92, evidência de qualidade moderada, 46 estudos) e com 4-6 semanas (RR 0,79, IC95% 0,71-0,89, evidência de qualidade moderada, 32 estudos). Rebaixamos a qualidade da evidência para moderada porque havia alta heterogeneidade nessas metanálises.

Para investigar a heterogeneidade nos quatro desfechos primários, fizemos as seguintes análises de subgrupos: a pessoa que ofereceu o apoio, o tipo de apoio, o momento do apoio, a taxa inicial de amamentação e o número de contatos pós-natais. Esses fatores não conseguiram explicar a heterogeneidade encontrada. Os testes de interação foram significantes em algumas análises, porém recomendamos cautela ao interpretar os resultados dos subgrupos devido à heterogeneidade. O apoio extra oferecido tanto por leigos como por profissionais teve impacto positivo sobre os resultados da amamentação. Vários fatores, como intervenções com um componente presencial, apoio por leigos e uma sequência pré-agendada de quatro a oito contatos, podem ter contribuído com os resultados nas mulheres em amamentação exclusiva. Porém, devido à alta heterogeneidade entre os grupos em todas essas análises, recomendamos cautela na hora de tirar conclusões especificas baseadas nos resultados dos subgrupos. Não encontramos evidências de diferenças entre os subgrupos para o desfecho ”qualquer tipo de amamentação”.

Conclusão dos autores

O apoio à amamentação aumenta a duração da amamentação e a amamentação exclusiva. O apoio efetivo à amamentação inclui as seguintes características: ser oferecido de rotina, por pessoas treinadas, durante a gestação ou no pós-parto, incluir visitas pré-agendadas para que as mulheres possam saber antecipadamente quando o apoio estará disponível, ser adaptado às necessidades locais e do grupo populacional. O apoio tem maior probabilidade de ter sucesso em locais com altas taxas de mulheres que já iniciaram a amamentação. O apoio pode ser oferecido tanto por profissionais quanto por leigos ou outras mães apoiadoras, ou uma combinação de ambos. As estratégias baseadas principalmente no apoio presencial têm maior probabilidade de sucesso para mães que praticam amamentação exclusiva.

摘要

支持健康足月婴儿母亲的健康母乳喂养

研究背景

有大量的证据表明,哺乳喂养与婴儿和母亲的重要健康风险有关。2003年,世界卫生组织建议将婴儿完全母乳喂养到六月龄,母乳喂养继续作为婴儿饮食的重要组成部分,直到至少两岁。然而,目前许多国家的母乳喂养率并不遵循这一建议。

研究目的

描述已经在对照研究中评估过的母乳喂养支持的形式,干预措施的时间安排和使用背景。

为了研究不同模式提供类似的支持性干预措施的有效性(例如,提供的支持是主动的还是被动的,面对面的还是通过电话),以及是否含有产前和产后的阶段比仅在产后阶段的干预更有效。

审查不同的护理提供者和(有可用信息)培训的有效性。

为探讨背景母乳喂养率与支持效果之间的相互作用,

检索策略

我们检索了Cochrane妊娠和分娩的试验注册库(2016年2月29日)和研究的参考文献目录。

标准/纳入排除标准

随机或半随机对照试验,比较对健康足月婴儿的健康母乳喂养母亲的额外支持和普通的产妇保健。

数据收集与分析

两位综述作者独立评估纳入的试验和偏倚风险,提取数据并检查其准确性。使用GRADE方法评估证据质量。

主要结果

这项最新的综述包括100项试验,涉及超过83246组母婴对,其中73项研究提供数据(58项独立随机试验和15项集群随机试验)。我们认为综述中包括的试验总体偏倚风险是混合的。在本次更新中纳入的31项新研究中,有21项为一项或多项主要结局提供了数据。在这项综述中提供数据的73项研究中,母婴对的总数是74656例(本综述的前一版本的总数为56451例)。73项研究在29个国家进行。分析的结果继续证实,所有形式的额外支持分析都显示,中止"任何母乳喂养"有所下降,包括部分和纯母乳喂养(在六个月前停止任何母乳喂养的平均风险比率(RR)为0.91,95%置信区间(CI)=0.88 - 0.95;中等质量的证据,51项研究)和四至六周前停止母乳喂养(平均RR=0.87,95%CI=0.80 - 0.95;中等质量的证据,33项研究)。所有形式的额外支持也表明,在六月内(平均风险比率(RR)=0.88,95%CI=0.85 - 0.92;中等质量的证据,46项研究)和四至六周(平均风险比率(RR)=0.79,95%CI=0.71 - 0.89;中等质量,32研究),停止纯母乳喂养的情况有所减少。由于非常高的异质性,我们将证据降级为中等质量。

我们调查了以下协变量的所有四项结局的实质异质性与亚组分析:谁提供护理,支持类型,支持时机,背景母乳喂养率和产后接触次数。协变量无法解释一般的异质性。虽然相互作用试验对某些分析有显著性,但由于异质性,我们建议对亚组的结果进行解释时慎重。外行和专业人士的额外支持对母乳喂养结局有积极影响。有几个因素也可能改善了实行纯母乳喂养的妇女的结果,例如以面对面的方式提供的干预、背景母乳喂养率高、外行的支持和具体的四至八次的时间表联系。然而,由于所有这些分析的组内异质性仍然很高,我们建议在根据亚组结果作出具体结论时要谨慎。我们注意到没有证据表明任何母乳喂养结局的亚组差异。

作者结论

当为妇女提供母乳喂养支持时,母乳喂养的持续时间和完全性母乳喂养率会增加。有效支持的特点包括:在产前或产后护理期间由训练有素的人员提供的标准,包括持续的定期访问,使妇女能够预测何时提供支持,在高背景率的环境中,支持可能更有效。支持可以由专业人士或外行/同行支持者提供,或者两者兼而有之。主要依靠面对面支持的战略更有可能成功地促进实施纯母乳喂养。

Plain language summary

Support for breastfeeding mothers

What is the issue?

The World Health Organization recommends that infants should be breastfed exclusively until six months of age with breastfeeding continuing as an important part of the infant’s diet until he or she is at least two years old. We know that breastfeeding is good for the short-term and long-term health of both infants and their mothers. Babies are less likely to develop infections in the digestive tract, lungs or airways, and ears. They are also less likely to become overweight and develop diabetes later in life. The mothers are less likely to develop diabetes and to experience breast or ovarian cancer. Many mothers may stop breastfeeding before they want to as a result of the problems they encounter. Good care and support may help women solve these problems so that they can continue to breastfeed.

Why is this important?

By knowing what kind of support can be provided to help mothers with breastfeeding, we can help them solve any problems and continue to breastfeed for as long as they want to, wherever they live. Stopping breastfeeding early may cause disappointment and distress for mothers and health problems for themselves and their infants. Support can be in the form of giving reassurance, praise, information, and the opportunity for women to discuss problems and ask questions as needed. This review looked at whether providing extra organised support for breastfeeding mothers would help mothers to continue to breastfeed when compared with standard maternity care. We were interested in support from health professionals including midwives, nurses and doctors, or from trained lay workers such as community health workers and volunteers.

What evidence did we find?

We searched for evidence on 29 February 2016 and identified a further 31 new trials for inclusion in the review. This updated review now includes 100 randomised controlled studies involving more than 83,246 women. The 73 trials that contributed to the analyses were from 29 countries and involved 74,656 women. Some 62% of the women were from high-income countries, 34% from middle income countries and 4% from low-income countries

All forms of extra organised support analyzed together showed an increase in the length of time women continued to breastfeed, either with or without introducing any other types of liquids or foods. This meant that fewer women stopped any breastfeeding or exclusively breastfeeding (moderate quality evidence) before four to six weeks and before six months. Both trained volunteers and doctors and nurses had a positive impact on breastfeeding.

Factors that may have contributed to the success for women who exclusively breastfed were face-to-face contact (rather than contact by telephone), volunteer support, a specific schedule of four to eight contacts and high numbers of women who began breastfeeding in the community or population (background rates).

The term 'high-quality evidence' means that we are confident that further studies would provide similar findings. No outcome was assessed as being 'high-quality'. The term 'moderate-quality evidence' means that we found wide variations in the findings with some conflicting results in the studies in this review. New studies of different kinds of support for exclusive breastfeeding may change our understanding of how to help women to continue with exclusive breastfeeding.

The methodological quality of the studies was mixed and the components of the standard care interventions and extra support interventions varied a lot and were not always well described. Also, the settings for the studies and the women involved were diverse.

What does this mean?

Providing women with extra organised support helps them breastfeed their babies for longer. Breastfeeding support may be more helpful if it is predictable, scheduled, and includes ongoing visits with trained health professionals including midwives, nurses and doctors, or with trained volunteers. Different kinds of support may be needed in different geographical locations to meet the needs of the people within that location. We need additional randomised controlled studies to identify what kinds of support are the most helpful for women.

Résumé simplifié

Prise en charge des mères allaitantes

L'Organisation Mondiale de la Santé recommande que les nouveau-nés soient exclusivement allaités jusqu'à l'âge de six mois avec poursuite de l'allaitement comme élément important du régime alimentaire du nouveau-né jusqu'à au moins l'âge de deux ans. Cette recommandation a été émise car il existe des preuves probantes de risques à court et long terme sur la santé des nouveau-nés et de leurs mères liés à l'absence d'allaitement. De nombreuses mères cessent prématurément d'allaiter en raison de problèmes, dont bon nombre peuvent être évités grâce à des soins et une prise en charge adaptés. Cet arrêt prématuré peut être source de déception et d'angoisse pour les mères, mais aussi de problèmes de santé pour leurs nouveau-nés et elles-mêmes. Une prise en charge de l'allaitement peut inclure des conseils visant à rassurer, à complimenter et à informer, mais c'est aussi une occasion de discuter et de répondre à des questions posées par la mère. La présente revue a examiné si une prise en charge supplémentaire pour les mères allaitantes, assurée par des professionnels et/ou des aidants ayant suivi une formation, permettait aux mères de continuer à allaiter comparée à la mise à disposition de soins de maternité standard. La revue a identifié 52 études contrôlées randomisées issues de 21 pays incluant plus de 56 000 femmes. Toutes les formes de prises en charge supplémentaires analysées montraient une augmentation de la durée d'allaitement et de la durée d'allaitement sans introduire d'autres types de liquides ou d'aliments. La prise en charge assurée par les aidants et les professionnels avait un effet positif sur les résultats liés à l'allaitement. Une prise en charge face à face était associée à un effet plus important du traitement par rapport à une prise en charge par téléphone. Cette prise en charge, uniquement proposée si les femmes recherchent une aide, a peu de chances d'être efficace. Cette indication signifie que les femmes doivent pouvoir bénéficier de visites prévisibles, planifiées et permanentes. Les interventions fournissant une prise en charge supplémentaire avaient des effets plus significatifs lorsque les taux de base d'initiation à l'allaitement étaient élevés. Les avis des femmes concernant les interventions de prise en charge n'étaient pas correctement signalés dans ces études. La prise en charge doit être adaptée au lieu et aux besoins du groupe de population. D'autres recherches seront nécessaires afin d'identifier les éléments les plus efficaces de la prise en charge.

Notes de traduction

Translated by: French Cochrane Centre

Translation supported by: Ministère du Travail, de l'Emploi et de la Santé Français

淺顯易懂的口語結論

支持母親餵哺母乳

議題是什麼?

世界衛生組織建議,應全母乳餵哺嬰兒直到6個月大; 2歲以前,母乳在嬰兒飲食中都應扮演主要角色。我們都知道母乳餵哺對嬰兒及母親的短期及長期健康有益處。嬰兒的消化道、肺、呼吸道及耳朵較不容易受到感染,嬰兒未來過胖及發展成糖尿病的機率也較低。母乳哺餵的母親較不容易得糖尿病,發生乳癌或卵巢癌的機會也較低。多數的母親會因遇到困難而提前停止母乳餵哺,給予良好的照顧及支持可幫助她們克服困難以繼續母乳餵哺。

為什麼此議題很重要?

藉由了解提供什麼樣的支持可以幫助母乳餵哺母親,我們可以協助她們解決困難,讓她們無論住在何處都能持續母乳餵哺。提早停止母乳餵哺,在精神上,可能會導致母親絕望以及焦慮,嬰兒及母親也會有健康問題。支持的形式包含給予保證、稱讚、提供資訊以及讓母親在需要時能討論她們的困難與詢問問題。這篇文獻回顧主要探討,相較於標準母體照護,額外提供母乳餵哺母親有組織的支持能不能幫助她們持續哺餵母乳。我們有興趣的支持管道來自衛生保健專業人士,包含助產士、護士及醫生,以及接受過訓練的業餘人士如社區衛生保健工作者以及志工。

我們找到了哪些證據?

我們搜尋了係至2016年2月9號的證據,並且進一步增加31個新試驗到此文獻回顧中。這份更新過的文獻回顧目前包含100個隨機對照試驗,超過83,246位女性。其中,用來分析的73個試驗來自29個不同國家,共包含74,656位女性。62%的女性來自高收入國家,34%來自中等收入國家,4%來自低收入國家。

分析結果顯示,無論有無額外給予其他種類的液體或食物,額外提供有組織的所有形式支持皆可增加女性母乳餵哺的時間。這個結果表示,在嬰兒4到6週前或6個月前結束母乳餵哺或全母乳餵哺的女性較少(證據品質中等)。接受過訓練的志工、醫生及護士接對母乳餵哺有正向的影響。

能成功讓女性全母乳餵哺的因素包含,面對面支持(電話支持效果較差)、志工的支持、特定的4至8個支持行程,以及社區中或人口中多數的女性開始母乳餵哺(普及率)。

「證據品質高」一詞表示,我們有信心進一步研究與我們的結論會有相似的結果。沒有結果被評估為高品質證據。「證據品質中等」一詞表示我們在研究中得到的結論具有高變異性,此文獻回顧也包含一些互相衝突的結果。針對提供不同支持對全母乳餵哺影響所做的新研究,可能會改變我們對如何幫助女性繼續全母乳餵哺的認知。

研究的方法學品質是混雜的,標準照護介入以及額外支持介入的內容組成有很大的差異,並且不總是被詳細的描述。此外,研究設計及參與的女性也不一致。

這代表什麼?

提供女性額外有組織的協助可以幫助她們延長母乳餵哺的時間。來自衛生保健專業人士的母乳餵哺支持,包含助產士、護士、醫生或接受過訓練的志工,並且是可預測、在計畫中以及持續性的拜訪可能會更有幫助。在不同地理位置的人可能會需要不同種類的支持。我們需要額外的隨機對照試驗來了解何種支持對女性有最大的幫助。

譯註

翻譯者:林映妤
服務單位:自由譯者

本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行
聯絡E-mail:cochranetaiwan@tmu.edu.tw

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Sokongan untuk ibu-ibu yang memberi susu ibu

Apakah isunya?

Pertubuhan Kesihatan Sedunia (WHO) mengesyorkan bahawa bayi harus diberi susu ibu secara eksklusif sehingga usia 6 bulan dengan meneruskannya sebagai satu komponen penting diet bayi sehingga sekurang-kurangnya usia dua tahun. Kita tahu bahawa penyusuan susu ibu adalah baik untuk kesihatan wanita dan bayi mahupun jangka masa pendek atau panjang. Bayi-bayi kurang cenderung untuk mendapat jangkitan dalam saluran penghadaman, paru-paru atau saluran udara, dan telinga. Mereka juga kurang cenderung untuk menjadi gemuk dan mengalami penyakit kencing manis pada masa hadapan. Ibu-ibu juga kurang cenderung untuk mendapat penyakit kencing manis dan mengalami kanser payudara atau kanser ovari. Ramai ibu mungkin menghentikan penyusuan lebih awal akibat permasalahan yang mereka hadapi. Penjagaan dan sokongan yang baik boleh membantu wanita menyelesaikan masalah-masalah ini supaya mereka boleh terus menyusukan bayi.

Kenapa ianya penting?

Dengan mengetahui apa jenis sokongan boleh disediakan untuk membantu ibu-ibu dengan penyusuan susu ibu, kami boleh membantu mereka menyelesaikan masalah dan meneruskan penyusuan selama mana yang mereka mahu, dan di mana sahaja mereka berada. Penghentian awal penyusuan boleh menyebabkan kekecewaan dan distres bagi ibu dan masalah kesihatan untuk ibu dan bayi. Sokongan boleh dalam bentuk jaminan, pujian, maklumat, dan peluang bagi wanita untuk membincangkan masalah dan bertanya soalan apabila perlu. Ulasan ini melihat sama ada penyediaan sokongan tambahan yang teratur untuk ibu-ibu yang menyusukan bayi boleh membantu ibu-ibu untuk meneruskan penyusuan berbanding penjagaan bersalin standard. Kami berminat dalam sokongan daripada profesional kesihatan termasuk bidan, jururawat dan doktor, atau daripada pekerja biasa yang dilatih seperti pekerja kesihatan masyarakat dan sukarelawan.

Apakah bukti yang kami perolehi?

Kami mencari bukti pada 29 Februari 2016 dan mengenal pasti lebih 31 kajian baru untuk dimasukkan dalam ulasan ini. Ulasan kemaskini memasukkan 100 kajian rawak terkawal yang melibatkan lebih daripada 83,246 wanita. 73 kajian yang menyumbang kepada analisis adalah dari 29 negara dan melibatkan 74,656 wanita. 62% daripada wanita-wanita tersebut adalah dari negara-negara berpendapatan tinggi, 34% daripada negara berpendapatan sederhana dan 4% daripada negara-negara berpendapatan rendah

Semua bentuk sokongan tambahan terancang telah dianalisis bersama-sama dan menunjukkan peningkatan jangka masa wanita untuk terus menyusukan, sama ada memperkenalkan cecair atau makanan lain. Ini bermakna kurang wanita menghentikan penyusuan atau menyusukan secara eksklusif (bukti kualiti sederhana) sebelum empat hingga enam minggu dan sebelum enam bulan. Kedua-dua sukarelawan terlatih, doktor dan jururawat memberi impak positif kepada penyusuan susu ibu.

Faktor-faktor yang mungkin menyumbang kepada kejayaan untuk wanita yang menyusukan secara eksklusif adalah pertemuan bersemuka (bukan perhubungan melalui telefon), sokongan sukarela, suatu jadual tertentu bagi empat hingga lapan kenalan dan sebilangan besar wanita dalam masyarakat atau populasi yang mula menyusukan (kadar latar belakang).

Istilah 'bukti berkualiti tinggi' bermakna kami yakin bahawa kajian lanjut akan memberi penemuan yang serupa. Tiada hasil yang dinilai sebagai 'bukti berkualiti tinggi'. Istilah 'bukti berkualiti sederhana' bermakna kami mendapati variasi penemuan yang luas dengan beberapa keputusan yang bercanggah dalam kajian-kajian bagi ulasan ini. Kajian-kajian baru dengan pelbagai jenis sokongan untuk penyusuan susu ibu eksklusif mungkin mengubah pemahaman bagaimana untuk membantu wanita meneruskan penyusuan eksklusif.

Kualiti metodologi kajian-kajian adalah bercampur-campur dan komponen intervensi penjagaan standard dan intervensi sokongan tambahan banyak berbeza dan sering tidak diterangkan dengan baik. Selain itu, persekitaran bagi kajian-kajian dan wanita yang terlibat adalah pelbagai.

Apakah maksudnya?

Memberi wanita sokongan tambahan yang terancang membantu mereka untuk menyusukan bayi mereka dengan lebih lama. Sokongan penyusuan mungkin lebih membantu jika ia boleh diramalkan, dijadualkan, dan dimasukkan lawatan berterusan oleh pakar-pakar kesihatan termasuk bidan, jururawat dan doktor, atau sukarelawan terlatih. Pelbagai jenis sokongan mungkin diperlukan di lokasi geografi yang berbeza untuk memenuhi keperluan rakyat dalam lokasi tersebut. Kita perlu penambahan kajian rawak terkawal untuk mengenal pasti jenis sokongan yang paling membantu wanita.

Catatan terjemahan

Diterjemahkan oleh Raymond Chieng Siang Ching (Hospital Sibu). Disunting oleh Noorliza Mastura Ismail (Kolej Perubatan Melaka-Manipal). Untuk sebarang pertanyaan mengenai terjemahan ini sila hubungi raymondchieng@gmail.com.

Laički sažetak

Najbolji oblik podrške za dojilje

Istraživačko pitanje

Svjetska zdravstvena organizacija preporučuje isključivo dojenje novorođenčadi tijekom prvih 6 mjeseci života, nakon čega bi dojenje također trebalo nastaviti kao važan dio djetetove prehrane najmanje do druge godine života. Znamo da je dojenje dobro za kratkoročno i durogočno zdravlje majki i djece. Djeca koja su dojena imaju manju vjerojatnost oboljevanja od infekcija u probavnom sustavu, plućima ili dišnim putovima i od infekcija uha. Također imaju manju vjerojatnost od razvoja pretilosti i dijabetesa kasnije u životu. Majke koje doje imaju manju vjerojatnost razvoja dijabetesa, karcinoma dojke i karcinoma jajnika. Brojne žene prestanu dojiti prije nego to žele zbog niza problema s kojima se susreću. Dobra skrb i podrška mogu ženama pomoći u rješavanju tih problema tako da mogu nastaviti s dojenjem.

Zašto je ovaj Cochrane sustavni pregled važan?

Ako znamo kakva podrška može biti korisna ženama koje doje, onda im možemo pomoći riješiti probleme s kojima se susreću i omogućiti im nastavak dojenja dok god to žele, bez obzira na to gdje žive. Preuranjeno prekidanje dojenja može uzrokovati razočaranje i stres kod majke te zdravstvene probleme i kod majke i kod djeteta. Podrška može biti u obliku pohvale, informacija i prilika za razgovor o problemima i pitanje pitanja ako je potrebno. Ovaj Cochrane sustavni pregled je analizirao kliničke pokuse u kojima je ispitano da li pružanje organizirane podrške može pomoći dojiljama da nastave dojiti u usporedbi sa standardnom skrbi za dojilje. Zanimala nas je podrška koju pružaju zdravstveni radnici, uključujući babice, medicinske sestre i liječnike, ili educirani laici kao što su volonteri.

Rezultati pretraživanja literature

Literatura je pretražena 29. veljače 2017. i pronašli smo 31 novo istraživanje za uključenje u ovaj sustavni pregled literature. Ovaj obnovljeni Cochrane sustavni pregled sada uključuje 100 randomiziranih kontroliranih istraživanja s više od 83.246 žena. U analize su uključeni podatci iz 73 studije, u kojima je sudjelovalo 74.656 žena iz 29 zemalja. U tim je studijama bilo 63% žena iz zemalja visokih prihoda, 34% žena iz zemalja srednjih prihoda i 4% iz zemalja niskih prihoda.

Kad su analizirani zajedno svi oblici dodatne podrške, pokazalo se da mogu povećati duljinu vremena tijekom kojeg žena nastavlja dojiti, sa ili bez uvođenja dodatnih vrsta tekućine ili hrane. To znači da je manje žena prestalo s dojenjem ili isključivim dojenjem (dokazi umjerene kvalitete) prije 4. ili 6. tjedna ili prije 6. mjeseca nakon rođenja djeteta. I educirani volonteri i liječnici i sestre imali su pozitivan učinak na dojenje.

Faktori koji su mogli pridonijeti uspjehu za žene koje isključivo doje bili su osobni kontakt (bolji nego kontakt telefonom), podrška volontera, program u kojem su žene imale 4-8 kontakata i visok broj žena koje su počele dojiti u zajednici ili populaciji.

Izraz "dokazi visoke kvalitete" znači da smo vrlo uvjereni da bi daljnja istraživanja dala slične rezultate. Niti jedan rezultat nije procijenjen kao dokaz "visoke kvalitete". Izraz "dokazi umjerene kvalitete" znači da su dokazi bili šaroliki, i da ima određenih suprotstavljenih dokaza u različitim uključenim studijama. Nova istraživanja o različitim programima potpore za isključivo dojenje mogli bi promijeniti naše razumijevanje o tome kako pomoći ženama da nastave s isključivim dojenjem.

Metodološka kvaliteta tih istraživanja bila je različita i komponente standardne skrbi i dodatne podrške vrlo su se razlikovale među studijama, i uz to često nisu bile dobro opisane. Osim toga, istraživanja su provedena u različitim okruženjima pa zbog toga možda nisu usporediva.

Značenje rezultata

Ako se ženama omogući dodatna organizirana podrška, one će dulje dojiti svoju djecu. Podrška dojenju može biti korisna ako je predvidljiva, planirana i ako uključuje višestruke sastanke s educiranim zdravstvenim radnicima, uključujući babice, sestre, liječnike i educirane volontere. Različiti oblici podrške mogli bi biti potrebni na različitim geografskim lokacijama kako bi se udovoljilo potrebama žena u različitim sredinama. Potrebna su nova randomizirana kontrolirana istraživanja kako bi se utvrdilo koji oblici podrške su ženama najkorisniji.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Livia Puljak
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

எளியமொழிச் சுருக்கம்

தாய் பாலூட்டும் தாய்களுக்கான ஆதரவு

பச்சிளங் குழந்தைகள் ஆறு மாத வயது வரை பிரத்தேயகமாக தாய் பாலூட்டப்பட வேண்டும் மற்றும் இரண்டு வருட வயது வரை பச்சிளங் குழந்தையின் உணவுத் திட்டத்தில் ஒரு முக்கியமான அங்கமாக தாய்ப்பால் தொடரப்படவேண்டும் என்று உலக சுகாதார நிறுவனம் பரிந்துரைக்கிறது. தாய் பாலுட்டாமல் இருப்பது, பச்சிளங் குழந்தைகள் மற்றும் அவர்களின் தாய்மார்களுக்கு குறுகிய-கால மற்றும் நீண்ட-கால ஆரோக்கிய அபாயத்தை ஏற்படுத்தும் என்பதற்கு அதிகளவிலான ஆதாரம் இருப்பதே இதற்கு காரணமாகும். நல்ல பராமரிப்பு மற்றும் ஆதரவுடன் தடுக்கப்பட முடிந்த பெரும்பாலான பிரச்னைகளால், பல தாய்மார்கள் தேவைப்படுவதற்கு முன்பதாகவே பாலூட்டுவதை நிறுத்துவர். இந்த குறித்த காலத்திற்கு முந்தைய தொடராமை, தாய்மார்களுக்கு ஏமாற்றம் மற்றும் வேதனையை ஏற்படுத்தக் கூடும் மற்றும் அவர்களுக்கும் பச்சிளங் குழந்தைகளுக்கும் ஆரோக்கிய பிரச்னைகளை ஏற்படுத்தும். மறுநம்பிக்கை, புகழ்ச்சி, தகவல், மற்றும் கலந்துரையாடுவதற்கு ஒரு வாய்ப்பு தருதல் மற்றும் தாயின் கேள்விகளுக்கு பதிலளித்தல் ஆகியவை பாலூட்டுவதற்கான ஆதரவில் அடங்கும். வழக்கமான மகப்பேறு பராமரிப்பை ஒப்பிடுகையில், தொழில் வல்லுநர்கள் அல்லது பயிற்சியளிக்கப்பட்ட பொது மக்கள் அல்லது இருவர் மூலம் பாலூட்டும் தாய்களுக்கு வழங்கப்படும் கூடுதலான ஆதரவு, தாய்மார்கள் அவர்கள் தாய்பாலூட்டுவதை தொடர உதவுமா என்பதை இந்த திறனாய்வு கண்டது. 21 நாடுகளிலிருந்து, 56,000-க்கும் அதிகமான பெண்களை சேர்த்திருந்த 52 சீரற்ற கட்டுப்படுத்தப்பட்ட சோதனைகளை இந்த திறனாய்வு கண்டது. அனைத்து வகையான கூடுதல் ஆதரவின் கூட்டு பகுப்பாய்வு, பெண்கள் தாய்பாலூட்டுவதை தொடர்ந்த கால அளவின் அதிகரிப்பையும் எனவும் மற்றும் பிற வகையான திரவங்கள் அல்லது உணவுகளை அறிமுகப்படுத்தாமல் தாய்பாலூட்டுவதை தொடர்ந்த கால அளவின் அதிகரிப்பையும் காட்டின. தொழில் வல்லுநர்கள் அல்லது பயிற்சியளிக்கப்பட்ட பொது மக்கள் மூலம் அளிக்கப்பட்ட ஆதரவு, தாய்பாலூட்டல் விளைவுகளின் மேல் ஒரு நேர்மறையான தாக்கத்தை ஏற்படுத்தியது. தொலைபேசி ஆதரவை விட, முக-முகமாய் அளிக்கப்பட்ட ஆதரவு பெரியளவு சிகிச்சை விளைவோடு சம்பந்தப்பட்டிருந்தது. பெண்கள் உதவி தேடும் போது மட்டும் அளிக்கப்பட்ட ஆதரவு திறனுடையதாக இருப்பதற்கு சாத்தியமில்லை. எதிர்பார்ப்போடு, அட்டவணையோடு, மற்றும் தொடரப்பட்ட சந்தித்தல்களோடு பெண்களுக்கு ஆதரவு அளிக்கப்பட வேண்டும் என்பதை சுட்டிக்காட்டுகிறது. தாய் பாலூட்டும் ஆரம்ப முயற்சிகளின் பின்புல நிகழ்வுகள் அதிகமாக இருந்த போது, கூடுதலான ஆதரவை வழங்கும் சிகிச்சை தலையீடுகள் முனைப்பான விளைவை கொண்டிருந்தன. இந்த ஆய்வுகளில், ஆதரவு சிகிச்சை தலையீடுகள் பற்றி பெண்களின் கருத்துகள் சரிவர அறிக்கையிடப்படவில்லை. அமைப்பிற்கு மற்றும் மக்கள் குழுவின் தேவைகளுக்கு ஏற்றவாறு ஆதரவு இருக்க வேண்டும். ஆதரவின் எந்த வகையான கூறுகள் மிகவும் திறன் மிக்கவையாக இருக்கும் என்பதை கண்டறிவதற்கு மேற்படியான ஆராய்ச்சி தேவைப்படுகிறது.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பாளர்கள்: சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், தங்கமணி ராமலிங்கம், ப்ளசிங்டா விஜய், ஸ்ரீகேசவன் சபாபதி.

Resumo para leigos

Apoio para mães que amamentam

Qual é a questão?

A Organização Mundial de Saúde recomenda que todas as crianças recebam apenas leite materno (amamentação exclusiva) até os seis meses de idade e que a amamentação continue até os dois anos de idade como um componente importante da dieta das crianças. Sabemos que a amamentação traz benefícios para a saúde do bebê e da mãe, no curto e no longo prazo. Os bebês amamentados têm menos risco de desenvolver infecções intestinais, pulmonares ou nos ouvidos. Eles também têm menos risco de terem sobrepeso ou diabetes no futuro. As mães que amamentam têm menos risco de terem diabetes e de desenvolverem câncer de mama ou de ovário. Devido aos problemas que elas encontram, muitas mães param de amamentar antes do que elas queriam. Com cuidados adequados e apoio, essas mulheres poderiam resolver esses problemas e continuar a amamentar.

Por que isso é importante?

Se soubermos que tipo de apoio podemos dar às mulheres para amamentarem, podemos ajudá-las a resolver os problemas que enfrentam e continuar a amamentar pelo tempo que elas quiserem. Parar de amamentar precocemente pode causar decepção e sofrimento para as mães, além de problemas de saúde para elas e seus bebês. O “apoio para a amamentação” inclui coisas como tranquilizar a mãe, elogiá-la, fornecer informações e a oportunidade de discutir os problemas dela e responder às suas perguntas. Esta revisão investigou se oferecer apoio adicional de forma organizada para mães que amamentam poderia ajudar a prolongar a duração da amamentação, quando comparado com cuidados habituais. Estávamos interessados em apoio oferecido por profissionais de saúde, incluindo obstetrizes, enfermeiras e médicos, ou por leigos treinados, como voluntários e agentes comunitários.

Que evidências encontramos?

Fizemos buscas por estudos publicados até 29 de fevereiro 2016 e encontramos mais 31 ensaios clínicos randomizados novos que puderam ser incluídos nesta atualização da revisão. A última versão da revisão inclui agora 100 estudos clínicos controlados com mais de 83.246 mulheres. Os 73 estudos que contribuíram com dados para as análises foram conduzidos em 29 países e envolveram 74.656 mulheres. Cerca de 62% das participantes eram de países de alta renda, 34% de países de renda média e 4% de países de baixa renda.

Todas as formas de apoio adicional, analisadas em conjunto, aumentaram o tempo em que as mulheres continuaram a amamentar no peito, com ou sem oferecer outros tipos de líquidos ou alimentos para seus bebês. Isso significa que existem evidências de qualidade moderada mostrando que o apoio adicional diminui o número de mulheres que param de amamentar (parcial ou exclusivamente) antes de quatro a seis semanas e antes do sexto mês. Os leigos treinados, assim como os médicos e enfermeiras, tiveram um impacto positivo sobre a amamentação.

Os fatores que podem contribuir para o sucesso da amamentação exclusiva são: apoio presencial (cara a cara, em vez de apoio por telefone), apoio de voluntários, apoio oferecido de forma programada (quatro a oito contatos pré-agendados) e apoio oferecido em locais onde as taxas existentes de amamentação inicial eram mais altas.

O termo “evidência de alta qualidade” significa que temos certeza que novos estudos chegariam a resultados semelhantes aos existentes até agora. Não encontramos evidência de alta qualidade para nenhum dos desfechos avaliados. O termo “evidência de qualidade moderada” significa que encontramos muita variação, ou resultados opostos, nos estudos desta revisão. Novos estudos sobre diferentes tipos de apoio para amamentação exclusiva podem mudar nossas conclusões sobre como ajudar mulheres a continuarem com a amamentação exclusiva.

A qualidade metodológica dos estudos foi variada. Os tipos de cuidados habituais e de apoio extra oferecidos às mães também variaram bastante e nem sempre havia uma descrição detalhada sobre isso nos diversos estudos. Além disso, houve bastante variação quanto aos locais onde os estudos foram conduzidos e aos tipos de participantes envolvidos nos estudos.

O que isso significa?

Oferecer apoio adicional às mães as ajuda a amamentar seus bebês por mais tempo. O apoio pode ser mais efetivo se ele for oferecido de forma planejada, pré-agendada e incluir visitas por profissionais de saúde treinados (como obstetrizes, enfermeiras e médicos) ou por voluntários treinados. Diferentes tipos de apoios podem ser necessários em diferentes regiões geográficas para atender às necessidades das populações locais. Precisamos de mais estudos controlados para saber que tipos de apoio são mais úteis para as mulheres.

Notas de tradução

Tradução do Centro Cochrane do Brasil (Maria Regina Torloni). Contato: tradutores@centrocochranedobrasil.org.br.

Резюме на простом языке

Поддержка кормящих матерей

В чем суть проблемы?

Всемирная организация здравоохранения рекомендует грудное вскармливание: исключительно грудное вскармливание до шести месяцев от рождения и как важную часть диеты младенца, пока младенцу не исполнится два года. Мы знаем, что кормление грудью хорошо для краткосрочного и долгосрочного здоровья обоих: для младенцев и для их матерей. Младенцы менее подвержены риску развития инфекций пищеварительного тракта, легких или дыхательных путей и ушей. У них также меньше шансов развития диабета в дальнейшей жизни и накопления избыточного веса. А мамы имеют меньше шансов заболеть диабетом и раком молочной железы или раком яичников. Многие мамы могут прекратить грудное вскармливание прежде, чем они захотят, в результате проблем, с которыми они сталкиваются. Хороший уход и поддержка могут помочь женщинам решить эти проблемы, чтобы они могли продолжать кормить грудью.

Почему это важно?

Зная, какую поддержку можно оказать, чтобы помочь матерям с грудным вскармливанием, мы можем помочь им решить любые проблемы, чтобы они продолжали кормить грудью столько, сколько они хотят, где бы они ни жили. Раннее прекращение грудного вскармливания может вызвать страдания матерей и проблемы со здоровьем самих матерей и их детей. Поддержка может заключаться в придании уверенности, похвалах, информации, а также предоставлении возможностей для женщин, в виде обсуждения их проблем; можно также задавать женщинам вопросы по мере необходимости. В этом обзоре было рассмотрено, может ли дополнительная организованная поддержка кормящих матерей помочь матерям продолжать грудное вскармливание по сравнению со стандартной помощью (уходом) по беременности и родам. Нас интересовали вопросы поддержки со стороны специалистов в области здравоохранения, включая акушерок, медсестер и врачей, или кого-то из подготовленных непрофессиональных работников, таких как помощники здравоохранению из членов сообщества и волонтеров.

Какие доказательства мы обнаружили?

Мы провели поиск доказательств 29 февраля 2016 года и выявили еще 31 новое испытание для включения в обзор. Этот обновленный обзор теперь включает 100 рандомизированных контролируемых исследований с участием более 83 246 женщин. 73 исследования, которые внесли вклад в анализ, были проведены в 29 странах с участием 74 656 женщин. Около 62% женщин были из стран с высоким уровнем дохода, 34% - из стран со средним уровнем дохода и 4% - из стран с низким уровнем дохода.

Все формы дополнительной организованной поддержки, проанализированные вместе, показали увеличение продолжительности времени, в течение которого женщины продолжали грудное вскармливание, с или без введения каких-либо других жидкостей или продуктов. Это означало, что меньшее число женщин прекратили любое грудное вскармливание или исключительно грудное вскармливание (среднее качество доказательств), на сроке от четырех до шести недель и до шести месяцев. Как обученные волонтеры, так и врачи, и медсестры оказали положительное влияние на продолжительность грудного вскармливания.

Факторы, которые, возможно, способствовали успеху у женщин, которые кормили исключительно грудью, включали: взаимодействие со специалистами лицом к лицу (а не по телефону), конкретный график, заключавшийся в четырех до восьми взаимодействиях, и большое число женщин, которые начали грудное вскармливание в своем сообществе или населении (фоновые показатели).

Термин «высокое качество доказательств» означает, что мы уверены в том, что дальнейшие исследования будут предоставлять аналогичные результаты. Доказательства ни по одному из исходов не были оценены как доказательства «высокого качества». Термин «умеренное качество доказательств» означает, что мы нашли широкие вариации в результатах, в том числе и противоречивые результаты в исследованиях в этом обзоре. Новые исследования различных видов поддержки исключительно грудного вскармливания могут изменить наше понимание того, как помочь женщинам продолжать исключительно грудное вскармливание.

Методологическое качество исследований было смешанным и компоненты стандартных мероприятий по уходу и дополнительных мер поддержки варьировали, и не всегда были хорошо описаны. Кроме того, условия проведения исследований и включенные в них женщины были различными.

Что это значит?

Предоставление женщинам дополнительной организованной поддержки помогает им кормить грудью своих детей дольше. Поддержка грудного вскармливания может быть более полезной, если она предсказуема, планируется, и включает в себя постоянные визиты, проводимые квалифицированными специалистами здравоохранения, включая акушерок, медсестер и врачей, или обученных добровольцев. Различные виды поддержки могут быть необходимы в разных географических территориях для удовлетворения потребностей людей в этом месте. Нам нужны дополнительные рандомизированные контролируемые исследования для того, чтобы определить, какие виды поддержки являются наиболее полезными для женщин.

Заметки по переводу

Перевод: Гараева Айзяра Фаниловна. Редактирование: Юдина Екатерина Викторовна и Зиганшина Лилия Евгеньевна. Координация проекта по переводу на русский язык: Cochrane Russia - Кокрейн Россия (филиал Северного Кокрейновского Центра на базе Казанского федерального университета). По вопросам, связанным с этим переводом, пожалуйста, обращайтесь к нам по адресу: cochrane.russia.kpfu@gmail.com; cochranerussia@kpfu.ru

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Wsparcie dla matek karmiących piersią

Na czym polega problem?

Światowa Organizacja Zdrowia zaleca, aby niemowlęta były karmione wyłącznie piersią do końca szóstego miesiąca życia z kontynuacją karmienia naturalnym pokarmem jako ważną częścią diety małego dziecka do ukończenia dwóch lat. Wiemy, że karmienie piersią jest korzystne dla zdrowia matek jak i niemowląt w okresie krótko- oraz długoterminowym. U dzieci tych stwierdza się mniejsze prawdopodobieństwo wystąpienia infekcji przewodu pokarmowego, płuc, dróg oddechowych i uszu, ale także mniejsze ryzyko rozwoju nadwagi i cukrzycy w późniejszym życiu. U matek karmiących zmniejsza się ryzyko zachorowania na cukrzycę, raka piersi lub jajników. Wiele matek przestaje karmić piersią wcześniej, niż by tego chciały z powodu napotykania wielu problemów. Stosowna opieka i wsparcie mogą pomóc kobietom w rozwiązaniu tych problemów, tak aby mogły kontynuować karmienie piersią.

Dlaczego jest to tak ważne?

Wiedząc, jakie wsparcie można zapewnić kobietom przy karmieniu piersią, możemy pomóc im rozwiązać problemy, tak aby mogły kontynuować karmienie naturalnym pokarmem jak długo chcą i gdziekolwiek mieszkają. Wczesne przerwanie karmienia może spowodować rozczarowanie i zły stan emocjonalny matek oraz problemy zdrowotne u nich i ich dzieci. Wsparcie może mieć formę podpory psychicznej, pochwały, przekazania informacji oraz możliwości omówienia problemów i zadawania pytań w razie potrzeby. Celem niniejszego przeglądu było sprawdzenie, czy zorganizowanie wsparcia dla matek karmiących, w porównaniu ze zwykłą opieką może im pomóc w kontynuacji karmienia piersią. Interesowała nas opieka ze strony pracowników służby zdrowia takich, jak położne, pielęgniarki oraz lekarze lub przeszkolonych pracowników socjalnych i wolontariuszy.

Jakie dane znaleźliśmy?

Danych naukowych szukaliśmy 29 lutego 2016 r. i odnaleźliśmy 31 kolejnych badań, które spełniały warunki włączenia do tego przeglądu. Zaktualizowany przegląd zawiera obecnie 100 badań z randomizacją i grupą kontrolną obejmujących ponad 83 246 kobiet. Analiza objęła 73 badania kliniczne z 29 krajów, w których uczestniczyło w sumie 74 656 kobiet. Około 62% kobiet pochodziło z krajów wysoko rozwiniętych, 34% - ze średnio i 4% z nisko rozwiniętych krajów.

W analizie stwierdzono, że wszystkie formy dodatkowego zorganizowanego wsparcia wiązały się z wydłużeniem okresu karmienia z lub bez wprowadzenia do diety różnych płynów i pokarmów. Oznacza to, że mniej kobiet przestało karmić wyłącznie piersią przed czwartym - szóstym tygodniem życia lub przestało stosować jakąkolwiek formę karmienia naturalnego (dane naukowe umiarkowanej jakości) przed szóstym miesiącem życia dziecka. Zarówno wyszkoleni wolontariusze jak i lekarze oraz pielęgniarki mieli pozytywny wpływ na karmienie piersią.

Czynniki, które mogły wpłynąć na sukces w odniesieniu do kobiet karmiących wyłącznie piersią to kontakt "twarzą w twarz" (w odróżnieniu od konsultacji telefonicznych), wsparcie wolontariuszy, określony schemat czterech do ośmiu spotkań oraz duża liczba kobiet, które rozpoczęły karmić piersią w społeczności lub w populacji (wyjściowy odsetek kobiet karmiących).

Termin „dane wysokiej jakości” oznacza naszą pewność, że kolejne badania będą miały podobne wyniki. Żaden z rezultatów nie był określony jako „dane wysokiej jakości”. Termin „dane umiarkowanej jakości” oznacza, że znaleźliśmy w badaniach duże różnice pomiędzy wynikami, które mogą prowadzić do rozbieżnych wniosków. Nowe badania nad różnymi sposobami wsparcia kobiet karmiących mogą zmienić nasze rozumienie pomocy mającej na celu wydłużenie okresu karmienia.

Jakość metodologiczna badań była zróżnicowana, a formy wsparcia dodatkowego i zwykłej opieki często znacznie różniły się między sobą i nie były zawsze prawidłowo opisane. Ponadto ustawienia dla poszczególnych badań i kobiety biorące w nich udział były różnorodne.

Co to oznacza?

Zapewnienie kobietom dodatkowego wsparcia pomaga im karmić piersią dłużej. Pomoc taka może być skuteczniejsza gdy będzie przewidywalna, zaplanowana i obejmie spotkania z przeszkolonymi pracownikami służby zdrowia, takimi jak położne, pielęgniarki i lekarze lub z przeszkolonymi wolontariuszami. Różne rodzaje wsparcia mogą być potrzebne w różnych miejscach na ziemi, tak aby sprostać potrzebom lokalnych mieszkańców. Potrzebujemy dodatkowych badań z grupą kontrolną i z randomizacją, aby stwierdzić, jaki rodzaj wsparcia jest najbardziej pomocny dla kobiet.

Uwagi do tłumaczenia

Tłumaczenie: Aleksandra Gołębiowska Redakcja: Piotr Szymczak, Małgorzata Kołcz

Laienverständliche Zusammenfassung

Unterstützung für stillende Mütter

Worum geht es?

Die Weltgesundheitsorganisation empfiehlt, Säuglinge in den ersten sechs Lebensmonaten ausschließlich durch Stillen zu ernähren und das Stillen bis zum Alter von zwei Jahren als wichtigen Baustein der kindlichen Ernährung beizubehalten. Wir wissen, dass Stillen sich kurzfristig und langfristig positiv auf die Gesundheit von Säuglingen und ihren Müttern auswirkt. Bei gestillten Säuglingen treten mit geringerer Wahrscheinlichkeit Infektionen des Verdauungstrakts, der Lunge oder der Atemwege sowie der Ohren auf. Auch für die Entstehung von Übergewicht und das Auftreten von Diabetes im späteren Leben besteht für gestillte Kinder eine geringere Wahrscheinlichkeit. Für stillende Mütter besteht ein geringeres Risiko für Diabetes sowie für Brust- und Eierstockkrebs. Viele Mütter hören möglicherweise früher mit dem Stillen auf, als sie selbst wünschen, weil sie auf Probleme stoßen. Eine gute Versorgung und Unterstützung können den Frauen dabei helfen, diese Probleme zu lösen, damit sie weiterstillen können.

Warum ist das wichtig?

Wenn wir wissen, wie wir Mütter beim Stillen unterstützen können, ist es möglich, ihnen bei der Lösung eventueller Probleme zu helfen, damit sie so lange weiterstillen können, wie sie möchten, und zwar unabhängig davon, wo sie leben. Ein vorzeitiges Beenden des Stillens kann zu Enttäuschung und Stress bei den Müttern und zu Gesundheitsproblemen für sie und ihre Säuglinge führen. Unterstützung kann in Form von Bestärkung, Lob, Informationen und Gelegenheiten zum Besprechen von Problemen und zum Stellen von Fragen nach Bedarf erfolgen. Dieser Review untersuchte, ob das zusätzliche Angebot organisierter Unterstützung für stillende Mütter ihnen im Vergleich mit der herkömmlichen Mütterberatung beim Weiterstillen hilft. Uns interessierte dabei Unterstützung durch medizinisches Fachpersonal einschließlich Hebammen, Pflegepersonal und Ärzten oder durch geschulte Laien wie Gesundheitspfleger (Community Health Workers) und Freiwillige.

Welche Evidenz haben wir gefunden?

Wir suchten am 29. Februar 2016 nach Evidenz und fanden weitere 31 neue Studien, die wir in den Review aufnehmen konnten. Dieser aktualisierte Review umfasst nun 100 randomisierte kontrollierte Studien mit mehr als 83.246 Frauen. Die 73 Studien, die Daten zur Analyse beisteuerten, stammten aus 29 Ländern und wurden mit 74.656 Frauen durchgeführt. Rund 62 % der Frauen kamen aus Ländern mit hohem Einkommen, 34 % aus Ländern mit mittleren Einkommen und 4 % aus Ländern mit geringem Einkommen.

Alle Formen zusätzlicher organisierter Unterstützung ergaben bei der gemeinsamen Analyse eine Zunahme des Zeitraums, über den die Frauen weiterstillten, entweder mit oder ohne Einführung anderer Flüssigkeiten oder Nahrungsmittel. Das bedeutet, dass weniger Frauen vor dem Ablauf von vier bis sechs Wochen bzw. sechs Monaten mit dem Stillen oder dem Vollstillen aufhörten (Evidenz von moderater Qualität). Sowohl geschulte Freiwillige als auch Ärzte und Pflegepersonal hatten einen positiven Einfluss auf das Stillen.

Zu den Faktoren, die möglicherweise zum Erfolg bei den voll stillenden Frauen beigetragen haben könnten, gehörten persönlicher Kontakt (statt Telefonkontakt), Unterstützung durch Freiwillige, ein spezifischer Zeitplan mit vier bis acht Kontakten und eine hohe Anzahl von Frauen in der Gemeinschaft oder Bevölkerungsgruppe, die mit dem Stillen begannen (Hintergrundsraten).

Der Begriff „Evidenz von hoher Qualität“ bedeutet, dass wir uns sicher sind, dass weitere Studien ähnliche Ergebnisse zeigen würden. Kein Endpunkt wurde mit „hoher Qualität“ bewertet. Der Begriff „Evidenz von moderater Qualität“ bedeutet, dass wir eine große Bandbreite an Variationen in den Ergebnissen fanden, wobei die Ergebnisse einiger Studien in diesem Review sich widersprachen. Neue Studien zu verschiedenen Arten der Unterstützung des Vollstillens könnten unser Verständnis davon verändern, wie man Frauen am besten hilft, das Vollstillen fortzusetzen.

Die methodische Qualität der Studien war gemischt und die Bestandteile der Maßnahmen der Standardversorgung und der zusätzlichen Unterstützung waren sehr unterschiedlich und wurden nicht immer ausreichend beschrieben. Auch bei den Rahmenbedingungen der Studien und bei den beteiligten Frauen gab es große Unterschiede.

Was bedeutet das?

Zusätzliche organisierte Unterstützung hilft Müttern, ihre Babys länger zu stillen. Die Stillunterstützung kann hilfreicher sein, wenn sie vorhersehbar ist, einem Plan folgt und Besuche von geschultem Gesundheitspersonal wie Hebammen, Pflegepersonal und Ärzten oder von geschulten Freiwilligen umfasst. Unterschiedliche Arten von Unterstützung könnten an verschiedenen geografischen Orten erforderlich sein, um die Bedürfnisse der dort ansässigen Menschen zu erfüllen. Wir brauchen zusätzliche randomisierte kontrollierte Studien, um festzustellen, welche Arten von Unterstützung für die Frauen am hilfreichsten sind.

Anmerkungen zur Übersetzung

S. Schmidt-Wussow, freigegeben durch Cochrane Deutschland

概要

支持母亲母乳喂养

有什么问题?

世界卫生组织建议,婴儿应专门母乳喂养,直到六个月大时,母乳喂养仍然是婴儿饮食的重要组成部分,直到他或她至少两岁。我们知道母乳喂养对婴儿和母亲的短期和长期健康都有益的。婴儿发生消化道、肺部或呼吸道、耳内感染的可能性更低。他们在以后的生活中变得超重和患糖尿病的可能性更低。母亲患糖尿病以及患乳腺癌或卵巢癌的可能性更低。许多母亲可能会因为遇到问题而停止母乳喂养。良好的护理和支持可以帮助妇女解决这些问题,以便她们能够继续母乳喂养。

为什么这个很重要?

通过了解可以提供什么样的支持来帮助母乳喂养的母亲,我们可以帮助他们解决任何问题,并继续母乳喂养,只要他们愿意,无论他们生活在哪里。提前停止母乳喂养可能会导致母亲的失望和痛苦以及自己和婴儿的健康问题。支持的形式可以是给予安慰、赞美、信息和妇女讨论问题的机会,并且在需要时提出问题。该综述调查了与标准的产妇护理相比,是否为母乳喂养的母亲提供额外的有组织的支持,会帮助母亲继续母乳喂养。我们感兴趣的是来自卫生专业人员的支持,包括助产士、护士和医生,或来自训练有素的非专业人员,如社区卫生工作者和志愿者的支持。

我们发现了什么证据?

我们在2016年2月29日检索了证据,并确定了另外31项新的试验纳入综述中。这项最新的综述现在包括了100个随机对照试验,涉及超过83246名女性。可用于分析的73项试验来自29国家,涉及74656名妇女。大约62%的妇女来自高收入国家,34%来自中等收入国家,4%来自低收入国家。

所有形式的额外有组织的支持干预汇总分析表明,无论是否引入任何其他类型的流食或食物,妇女继续母乳喂养的时间增加。这意味着更少的妇女在四至六周和六月之前停止母乳喂养或纯母乳喂养(中等质量的证据)。训练有素的志愿者,医生和护士对母乳喂养有积极的影响。

可能有助于完全母乳喂养的妇女取得成功的因素是面对面接触(而不是通过电话联系)、志愿者支持、4到8次接触的具体时间表以及在社区或人口中母乳喂养妇女的高数目(背景比率)。

"高质量的证据"一术语意味着我们有信心进一步的研究将提供类似的结果。没有结果被评估为“高质量”。“中等质量的证据”这个术语意味着我们发现结果有很大的变异,在本综述的研究中有一些矛盾的结果。对于纯母乳喂养的各种支持的新研究可能会改变我们对如何帮助女性继续纯母乳喂养的理解。

研究的方法学质量参差不齐,标准护理干预措施和额外支持干预措施的组成部分差异很大,而且并不总是很好地被描述。此外,研究的类型和参与的妇女是多种多样的。

这是什么意思?

为妇女提供额外的有组织的支持,可以帮助她们母乳喂养婴儿的时间更长。如果母乳喂养的支持是可预期的、计划好的,并且有训练有素的卫生专业人员(包括助产士、护士和医生)或训练有素的志愿者进行持续的访问,那么对母乳喂养可能会更有帮助。在不同的地理位置,可能需要不同类型的支持,以满足该地区人民的需要。我们需要额外的随机对照研究,以确定哪些类型的支持对妇女最有帮助。

翻译注解

译者:张亚鹏,审校:马思思。北京中医药大学循证医学中心,2018年3月24日。

Summary of findings(Explanation)

Summary of findings for the main comparison. All forms of support versus usual care
  1. 1 Sensitivity analyses restricted to trials of low risk of bias for allocation concealment showed similar effects for all four outcomes, with a reduction in effect size of (0 to 0.08) and minimal differences in confidence intervals.

    2 Statistical heterogeneity, downgraded one level (I² = 55%).

    3 Statistical heterogeneity, downgraded one level (I² = 96%).

    4 There is some evidence of funnel plot asymmetry due to small studies with large effect sizes. Not downgraded.

    5 Statistical heterogeneity, downgraded one level (I² = 54%).

    6 Statistical heterogeneity, downgraded one level (I² = 97%).

All forms of support versus usual care
Patient or population: healthy breastfeeding mothers with healthy term babies
Setting: outpatient settings in multiple countries (8% low- or lower-middle income; 30% upper-middle income; 60% high-income countries)
Intervention: all forms of support
Comparison: usual care
OutcomesAnticipated absolute effects* (95% CI)Relative effect
(95% CI)
№ of participants
(studies)
Quality of the evidence
(GRADE)
Comments1
Risk with usual careRisk with all forms of support
Stopping breastfeeding (any) before last study assessment up to 6 monthsStudy populationaverage RR 0.91
(0.88 to 0.95)
21418
(51 RCTs)
⊕⊕⊕⊝
MODERATE2
We have not downgraded evidence for lack of blinding. However, no trial had adequate blinding of pregnant women or staff.
573 per 1000510 per 1000
(487 to 532)
Stopping exclusive breastfeeding before last study assessment up to 6 monthsStudy populationaverage RR 0.88
(0.85 to 0.92)
18591
(46 RCTs)
⊕⊕⊕⊝
MODERATE 3, 4
 
823 per 1000732 per 1000
(707 to 765)
Stopping breastfeeding (any) at up to 4-6 weeksStudy populationaverage RR 0.87
(0.80 to 0.95)
11264
(33 RCTs)
⊕⊕⊕⊝
MODERATE5
 
353 per 1000304 per 1000
(279 to 329)
Stopping exclusive breastfeeding at up to 4-6 weeksStudy populationRR 0.79
(0.71 to 0.89)
10960
(32 RCTs)
⊕⊕⊕⊝
MODERATE 4, 6
 
642 per 1000507 per 1000
(443 to 571)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Background

Description of the condition

Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women’s health (Victora 2016). For children, good quality evidence demonstrates that in both low-, middle- and high-income settings not breastfeeding contributes to mortality due to infectious diseases (Sankar 2015), hospitalisation for preventable disease such as gastroenteritis, and respiratory disease (Horta 2013), otitis media (Bowatte 2015), increased rates of childhood diabetes and obesity (Horta 2015a), and increased dental disease (Peres 2015; Tham 2015). For women, there is good quality evidence that not breastfeeding is associated with increased risks of breast and ovarian cancer, and diabetes (Chowdhury 2015). Lactational amenorrhoea is associated with exclusive/predominant breastfeeding and increases birth spacing when other forms of contraception are not available (Chowdhury 2015). Not being breastfed has an adverse impact on intelligence quotient (IQ), and educational and behavioural outcomes for the child (Heikkilä 2014; Heikkilä 2011; Horta 2015b; Quigley 2012). For many outcomes a dose-response relationship exists, with the greatest benefit resulting from breastfeeding exclusively, with no added food or fluids, for around six months, with breastfeeding continuing thereafter as an important component of the infant’s diet (Kramer 2012). The negative impact of not breastfeeding has been demonstrated in a range of settings and population groups, though the balance of risks and benefits varies from setting to setting; for example, gastroenteritis will result in much higher mortality in low-income countries (Horta 2013).

Few health behaviours have such a broad-spectrum and long-lasting impact on population health, with the potential to improve life chances, health and well-being. Victora 2016 estimated that each year, 823,000 deaths in children under five years and 20,000 deaths from breast cancer could be prevented by near universal breastfeeding. The cost burden of not breastfeeding was estimated by Rollins 2016 to represent 0.49% of world gross domestic product. The cost burden includes the cost of caring for children and women with chronic disease as well as short-term illness (Bartick 2010; Smith 2010).

The established negative impact on a population of not breastfeeding has resulted in global and national support for encouraging the initiation and continuation of breastfeeding. The World Health Organization (WHO) recommends that, wherever possible, infants should be fed exclusively on breastmilk until six months of age (WHO 2003), with breastfeeding continuing as an important part of the infant’s diet until at least two years of age. Other agencies and countries have endorsed the recommendation to breastfeed exclusively to around six months of age (EFSA Panel 2009; National Center for Health Statistics 2012).

Due to the lack of standardised infant feeding indicators in high-income countries, it is difficult to compare rates of breastfeeding across high-income countries, or between high-income, and low- and middle-income countries. Therefore reported rates of breastfeeding need to be treated with caution. Victora 2016 suggest that, in general, there is an inverse relationship between breastfeeding rates and national wealth, though this relationship does not necessarily hold at the level of population subgroups. In high-income countries, for example, the relationship is often seen to be the opposite, with rates higher among more affluent women (McAndrew 2012).

Although some high-income countries such as, Norway and Finland have high rates of both initiation and continuation of breastfeeding (Cattaneo 2010), rates in many high-income countries are low. Initiation rates have risen in some high-income countries in recent years (NHS England 2014; U.S. Department of Health and Human Services 2011), but there remains a marked decline in breastfeeding within the first few weeks after initiation, and exclusive breastfeeding to six months is rare (Cattaneo 2010; McAndrew 2012).

In middle- and low-income countries, while breastfeeding initiation and duration are generally higher than in high-income countries, the average rate of exclusive breastfeeding for children younger than six months is only 37% (Victora 2016). However, rates of exclusive breastfeeding for children younger than six months vary widely; Peru and Rwanda report rates of 72% and 85% respectively (UNICEF 2012), while in Nigeria the rate is only 17%. In some low- and middle-income countries, cultural practices such as prelacteal feeds, and giving water or teas alongside breastfeeding, account for the low rates of exclusive breastfeeding (Kimani-Murage 2011). This is particularly important as when breastfeeding continues for long periods of time, infant and young child mortality are reduced in the second year of life in low- and middle-income countries (Victora 2016).

Infant feeding is strongly related to inequalities in health, and, far from being an individual decision made by each woman, is influenced most strongly by structural determinants of health. The range of different rates of initiation and continuation of breastfeeding in different settings globally demonstrates that the key factors influencing infant feeding rates are likely to be sociocultural and related to societal and subgroup norms, public policy, and the availability of appropriate care and support, both professional and lay (EU Project on Promotion of Breastfeeding 2004; Rollins 2016). In high-income countries, for example, young mothers and women in low-income groups, or women who ceased full-time education at an early age, are least likely either to start breastfeeding or to continue for a period of time sufficient to benefit from the greatest health gain (McAndrew 2012). Migrant women have been shown to adopt breastfeeding practices that are more similar to the country in which they live, than the country of their birth (McLachlan 2006).

The early discontinuation of breastfeeding is not a decision that is taken lightly by women; it is associated with a high prevalence of problems such as painful breasts and nipples, concern about adequacy of milk supply and about the baby’s behaviour, and, in some settings, embarrassment related to breastfeeding in public. Many mothers report distress related to the decision to discontinue breastfeeding (McAndrew 2012), even in cultures where breastfeeding rates are high (Almqvist-Tangen 2012). A key factor is the widespread lack of appropriate education for health professionals in the prevention and treatment of breastfeeding problems, which means that in a wide range of settings women commonly do not receive the quality of care needed from the health services (Cattaneo 2010; Renfrew 2006). Enkin 2000 notes that industrial societies, on the whole, do not provide women with the opportunity to observe other breastfeeding women before they attempt breastfeeding themselves. In such societies, where breastfeeding is not normative behaviour and women may find it socially challenging to breastfeed, women are at particular risk of finding a serious lack of support to continue breastfeeding.

Description of the intervention

‘Support’ is complex and can include several elements such as emotional and esteem-building support (including reassurance and praise), practical help, informational support (including the opportunity to discuss and respond to women’s questions) and social support (including signposting women to support groups and networks) (Dykes 2006; Schmied 2011). It can be offered in a range of ways, by health professionals or lay people, trained or untrained, in hospital and community settings. It can be offered to groups of women or one-to-one, it can involve mother-to-mother support, and it can include family members (typically fathers or grandmothers) and wider communities. Support can be offered proactively by contacting women directly, or reactively, by waiting for women to get in touch. It can be provided face-to-face, by telephone or through social media. It can involve only one contact or regular, ongoing contact over several months.

Support is a complex intervention that tackles the multifaceted challenge of enabling women to breastfeed, and it should not be surprising that it varies from setting to setting and from study to study. However, it is likely that different forms of support in different contexts will be differentially effective. The global Baby Friendly Hospital Initiative (Baby Friendly Initiative in some countries), which is a complex intervention incorporating 10 steps to successful breastfeeding, has been shown to be associated with increased breastfeeding rates (Labbok 2012; Pérez-Escamilla 2016; Venancio 2011). Over 21,000 facilities in 198 countries have ever been accredited, representing 27.5% of maternities worldwide (Labbok 2012), but most babies are still not born in a Baby Friendly environment.

In many settings, the health professionals who provide standard maternity care lack in-depth knowledge of the prevention and treatment of breastfeeding problems. Therefore training and education of health professionals and others who provide breastfeeding support is critical. To address this, WHO and UNICEF (the United Nations Children's Fund) have developed two breastfeeding training programmes: the 40-hour Breastfeeding Counselling, and the five-day Infant and Young Child Feeding Counselling, to train a cadre of health workers that can provide skilled support to breastfeeding mothers and help them overcome problems (WHO/UNICEF 1993; WHO/UNICEF 2006).

How the intervention might work

Support for breastfeeding women can work in different ways for different women. Timely, skilled support will help women to avoid or overcome breastfeeding problems that may lead to cessation of breastfeeding. In settings where breastfeeding is not the social norm, support can increase women’s belief in breastfeeding, and give them confidence to continue breastfeeding in the face of societal and family pressures that might undermine breastfeeding. In settings where exclusive breastfeeding is rare, support can dispel myths about the need for additional foods or fluids alongside breastfeeding to meet babies’ nutritional needs.

Why it is important to do this review

It is fundamentally important to examine the support that mothers receive when breastfeeding to determine what might be effective in helping women continue to breastfeed, whatever setting they live in. There is evidence that effective breastfeeding support interventions are cost-effective and likely to realise a return on investment within a few years (Renfrew 2012a).

The purpose of this review is to examine interventions which provide extra support for mothers who are breastfeeding or considering breastfeeding; and to assess their impact on breastfeeding duration and exclusivity and, where recorded, on health outcomes and maternal satisfaction. This review is an update of the previously published version Renfrew 2012b. The focus of this review is support for mothers and babies who are part of the general healthy population of their countries; mothers of premature and sick babies and mothers with some medical conditions have additional issues with breastfeeding, and interventions to support these mothers need to be reviewed separately. A Cochrane Review of breastfeeding education and support for mothers with multiple pregnancies is in progress (Whitford 2015). Whilst many support interventions include breastfeeding education for mothers, our review excludes interventions described as solely educational in nature and interventions with no postnatal component. A Cochrane Review of antenatal breastfeeding education for increasing breastfeeding duration has been published (Lumbiganon 2012).

Specific objectives of this review are to describe forms of support which have been evaluated in controlled studies, and the settings in which they have been used. It was also of interest to examine the effectiveness of different modes of offering similar supportive interventions (for example, face-to-face or over the telephone), whether interventions containing both antenatal and postnatal elements were more effective than those taking place in the postnatal period alone, and whether the support was offered proactively to women, or whether they needed to seek it out. We also planned to examine the effectiveness of different care providers, and the possible impact of background breastfeeding rates in the countries or areas where the trials took place on the effectiveness of supportive interventions. It is important to note that the support interventions offered were in addition to standard care, which varied from setting to setting, though there are few settings in which standard care is consistently offered by people with training and skill in enabling women to breastfeed.

Objectives

  1. To describe forms of breastfeeding support which have been evaluated in controlled studies, the timing of the interventions and the settings in which they have been used.

  2. To examine the effectiveness of different modes of offering similar supportive interventions (for example, whether the support offered was proactive or reactive, face-to-face or over the telephone), and whether interventions containing both antenatal and postnatal elements were more effective than those taking place in the postnatal period alone.

  3. To examine the effectiveness of different care providers and (where information was available) training.

  4. To explore the interaction between background breastfeeding rates and effectiveness of support.

Methods

Criteria for considering studies for this review

Types of studies

All randomised or quasi-randomised controlled trials, with or without blinding. Cluster-randomised controlled trials were also eligible for inclusion.

Types of participants

Participants were healthy pregnant women considering or intending to breastfeed or healthy women who were breastfeeding healthy babies.Healthy women and babies were considered those who did not require additional medical care (e.g. women with diabetes, women with HIV/AIDs, overweight or obese women) or surgical care (e.g. women who required a Caesarean Section). Studies which focused specifically on women with additional care needs were excluded.

Types of interventions

Contact with an individual or individuals (either professional or volunteer) offering support which is supplementary to the standard care offered in that setting. ‘Support’ interventions eligible for this review could include elements such as reassurance, praise, information, and the opportunity to discuss and to respond to the mother’s questions, and could also include staff training to improve the supportive care given to women. It could be offered by health professionals or lay people, trained or untrained, in hospital and community settings. It could be offered to groups of women or one-to-one, including mother-to-mother support, and it could be offered proactively by contacting women directly, or reactively, by waiting for women to get in touch. It could be provided face-to-face or over the phone, and it could involve only one contact or regular, ongoing contact over several months. Studies were included if the intervention occurred in the postnatal period alone or also included an antenatal component. Interventions taking place in the antenatal period alone were excluded from this review, as were interventions described as solely educational in nature.

Types of outcome measures

The main outcome measure was the effect of the interventions on stopping breastfeeding by specified points in time. Primary outcomes were recorded for stopping any or exclusive breastfeeding before four to six weeks and before six months postpartum. Other outcomes of interest in previous versions of this review were stopping any or exclusive breastfeeding at other time points (two, three, four, nine and 12 months), measures of neonatal and infant morbidity (where available) and measures of maternal satisfaction with care or feeding method. Secondary outcomes were not considered in this update so that the review could be completed in time to inform the World Health Organisation’s review of the evidence and update of the WHO recommendations on breastfeeding in maternity facilities. A new set of core outcomes for Cochrane pregnancy and childbirth breastfeeding reviews is currently being developed and the outcomes from this core set may influence future outcomes chosen for this review.

Primary outcomes
  1. Stopping breastfeeding before six months postpartum.

  2. Stopping exclusive breastfeeding before six months postpartum.

  3. Stopping any breastfeeding before four to six weeks postpartum.

  4. Stopping exclusive breastfeeding before four to six weeks postpartum.

Secondary outcomes

We did not consider secondary outcomes in this 2016 update.

Search methods for identification of studies

The following methods section of this review is based on a standard template used by Cochrane Pregnancy and Childbirth.

Electronic searches

We searched the Cochrane Pregnancy and Childbirth’s Trials Register by contacting their Information Specialist (29 February 2016).

The Register is a database containing over 22,000 reports of controlled trials in the field of pregnancy and childbirth. For full search methods used to populate Pregnancy and Childbirth’s Trials Register including the detailed search strategies for CENTRAL, MEDLINE, Embase and CINAHL; the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service, please follow this link to the editorial information about Cochrane Pregnancy and Childbirth in the Cochrane Library and select the ‘Specialized Register ’ section from the options on the left side of the screen.

Briefly, Cochrane Pregnancy and Childbirth’s Trials Register is maintained by their Information Specialist and contains trials identified from:

  1. monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  2. weekly searches of MEDLINE (Ovid);

  3. weekly searches of Embase (Ovid);

  4. monthly searches of CINAHL (EBSCO);

  5. handsearches of 30 journals and the proceedings of major conferences;

  6. weekly current awareness alerts for a further 44 journals, plus monthly BioMed Central email alerts.

Search results are screened independently by two people and the full text of all relevant trial reports identified through the searching activities described above is reviewed. Based on the intervention described, each trial report is assigned a number that corresponds to a specific Pregnancy and Childbirth review topic (or topics), and is then added to the Register. The Information Specialist searches the Register for each review using this topic number rather than keywords. This results in a more specific search set, which has been fully accounted for in the relevant review sections (Included studies; Excluded studies; Studies awaiting classification; Ongoing studies).

(For details of search methods used in previous versions of this review, please see: Britton 2007; Renfrew 1995; Renfrew 2012b; Sikorski 1999; Sikorski 2002)

Searching other resources

We searched the reference lists of retrieved studies.

We did not apply any language or date restrictions.

Data collection and analysis

For methods used in the previous version of this review, see Renfrew 2012b.

For this update, the following methods (based on a standard template used by Cochrane Pregnancy and Childbirth) were used for assessing the 162 reports that were identified as a result of the updated search.

Selection of studies

Two review authors independently assessed all the potential studies identified as a result of the search strategy for inclusion. We resolved any disagreement through discussion and consulted a third review author if required.

Data extraction and management

We designed and piloted a form to extract data. For eligible studies, two review authors extracted information using the agreed form. We resolved discrepancies through discussion. Data were entered into Review Manager 5 software (RevMan 2014), and checked for accuracy.

When information regarding study methods and results was unclear, we attempted to contact authors of the original reports to provide further details.

Assessment of risk of bias in included studies

Two review authors independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (the Handbook) (Higgins 2011). Any disagreement was resolved by discussion or by involving a third assessor.

(1) Random sequence generation (checking for possible selection bias)

For each included study, we described the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

We assessed the method as:

  1. low risk of bias (any truly random process, e.g. random number table; computer random number generator);

  2. high risk of bias (any non-random process, e.g. odd or even date of birth; hospital or clinic record number);

  3. unclear risk of bias.

(2) Allocation concealment (checking for possible selection bias)

For each included study, we described the method used to conceal allocation to interventions prior to assignment and assessed whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed the methods as:

  1. low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);

  2. high risk of bias (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth);

  3. unclear risk of bias.

(3.1) Blinding of participants and personnel (checking for possible performance bias)

For each included study, we described the method used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We considered that studies were at low risk of bias if they were blinded, or if we judged that the lack of blinding unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed the methods as:

  1. low, high or unclear risk of bias for participants;

  2. low, high or unclear risk of bias for personnel.

(3.2) Blinding of outcome assessment (checking for possible detection bias)

For each included study, we described the method used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed methods used to blind outcome assessment as:

  1. low, high or unclear risk of bias.

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

For each included study, and for each outcome or class of outcomes, we described the completeness of data including attrition and exclusions from the analysis. We stated whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported, or could be supplied by the trial authors, we planned to re-include missing data in the analyses that we undertook.

We assessed methods as:

  1. low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);

  2. high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; ‘as treated’ analysis done with substantial departure of intervention received from that assigned at randomisation);

  3. unclear risk of bias.

(5) Selective reporting (checking for reporting bias)

For each included study, we described how we investigated the possibility of selective outcome reporting bias and what we found.

We assessed the methods as:

  1. low risk of bias (where it is clear that all of the study’s prespecified outcomes and all expected outcomes of interest to the review have been reported);

  2. high risk of bias (where not all the study’s prespecified outcomes have been reported; one or more reported primary outcomes were not prespecified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);

  3. unclear risk of bias.

(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)

We described for each included study any important concerns we had about other possible sources of bias.

(7) Overall risk of bias

We made explicit judgements about whether studies were at high risk of bias, according to the criteria given in the Handbook (Higgins 2011).

Overall findings for our assessment of risk of bias in the included studies are set out in Figure 1 and Figure 2.

Figure 1.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Figure 2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Assessment of the quality of the evidence using the GRADE approach

For this update the quality of the evidence was assessed using the GRADE approach as outlined in the GRADE handbook in order to assess the quality of the body of evidence relating to the following primary outcomes for the comparison, All forms of support versus usual care.

  1. Stopping breastfeeding before six months postpartum.

  2. Stopping exclusive breastfeeding before six months postpartum.

  3. Stopping any breastfeeding before four to six weeks postpartum.

  4. Stopping exclusive breastfeeding before four to six weeks postpartum.

The GRADEpro Guideline Development Tool was used to import data from Review Manager 5.3 in order to create ’Summary of findings’ tables (RevMan 2014). A summary of the intervention effect and a measure of quality for each of the above outcomes was produced using the GRADE approach. The GRADE approach uses five considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of the body of evidence for each outcome. The evidence can be downgraded from 'high quality' by one level for serious (or by two levels for very serious) limitations, depending on assessments for risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect estimates or potential publication bias.

Measures of treatment effect

Dichotomous data

For dichotomous data, we presented results as summary risk ratios with 95% confidence intervals.

Continuous data

There are no continuous data in this review.

Unit of analysis issues

Cluster-randomised trials

There are 15 cluster-randomised trials in the analyses. Their sample sizes have been adjusted using the methods described in the Handbook and by Donner 2000 incorporating an estimate of the intracluster correlation coefficient (ICC) derived from the trial (if possible). Where cluster adjusted confidence limits were presented but not the ICC, the design effect was estimated from comparison with limits based on the raw numbers. However, for Ochola 2013, outcome one of Elliott-Rudder 2014, arm two of Yotebieng 2015, adjusting for clustering based on the summary statistic made the standard error larger and the width of the confidence interval increased which resulted in a design of <1. Therefore, the adjustment for clustering resulted in an increase of the error sum of squares for the raw numbers given. As this was nonsensical, no adjustment for clustering was made for these studies. We have synthesised the findings from individually- and cluster-randomised trials provided that there was little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit was considered to be unlikely. We have carried out sensitivity analyses to investigate the effect of including cluster-randomised trials where no adjustment was possible. For all trials where ICCs were not reported, study authors will be contacted in the next version of the review.

Trials with multiple groups

In order to avoid 'double counting' in studies involving one control group and two different interventions groups, we split the control group number of events and participants in half, so that we could include two independent comparisons, as per methods described the Handbook [section16.5.4].

Dealing with missing data

For all outcomes, analyses were carried out, as far as possible, on an intention-to-treat basis, i.e. we attempted to include all participants randomised to each group in the analyses. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing.

For included studies, we have noted levels of attrition. We have not included outcomes in the analyses where more than 25% of the data were missing.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta-analysis using the Tau², I² and Chi² statistics. We regarded heterogeneity as substantial if I² was greater than 30% and either Tau² was greater than zero, or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. If we identified substantial heterogeneity (above 30%), we planned to explore it by prespecified subgroup analysis.

Assessment of reporting biases

For all outcomes we have ordered studies in terms of weight, where a sufficient number of studies contributed data, we have generated funnel plots. We examined plots visually to see whether there was any evidence of asymmetry that might suggest different treatment effects in smaller studies, which may indicate publication bias (Harbord 2006). We note however, that there are many other reasons for asymmetry in Funnel Plots such as heterogeneity.

Data synthesis

We carried out statistical analysis using Review Manager 5 software (RevMan 2014). At the outset, we had anticipated that there would be some heterogeneity between studies in terms of the interventions and the populations studied, we therefore decided to use random-effects meta-analysis for combining data. Random-effects meta-analysis estimates the average treatment effect, and this may not always be clinically meaningful. Furthermore, where there is high heterogeneity the applicability of the overall effect estimate is likely to vary in different settings and we therefore advise caution in the interpretation of results. The random-effects summary was treated as the average of the range of possible treatment effects and we discuss the clinical implications of treatment effects differing between trials. If the average treatment effect was not clinically meaningful, we planned not to combine trials. Since we used random-effects analyses, the results were presented as the average treatment effect with 95% confidence intervals, and the estimates of Tau² and I².

Subgroup analysis and investigation of heterogeneity

If we identified substantial heterogeneity, we investigated it using subgroup analyses and sensitivity analyses. We considered whether an overall summary was meaningful, and if it was, we used random-effects analysis to produce it.

We carried out the following subgroup analyses for the four primary outcomes.

  1. By type of supporter (professional versus lay person, or both).

  2. By type of support (face-to-face versus telephone support).

  3. By timing of support (antenatal and postnatal versus postnatal alone).

  4. By whether the support was proactive (scheduled contacts) or reactive (women needed to request support).

  5. By background breastfeeding initiation rates (low, medium or high background rates).

  6. By intensity of support (number of scheduled contacts).

Sensitivity analysis

We have carried out sensitivity analysis for primary outcomes by study quality; we did this by dividing the studies into subgroups according to whether they were at low risk of bias as opposed to unclear or high risk of bias. We have performed this for allocation concealment. Because we have excluded studies from any analyses if they had more than 25% attrition, we have not conducted sensitivity analyses for this item.

Results

Description of studies

Results of the search

In this updated version, we assessed 162 reports and have subsequently included a further 31 studies. We excluded 68 studies and have assigned the remainder as either an additional report of another study in the review, a study awaiting classification or an ongoing study (see Studies awaiting classification and Characteristics of ongoing studies). This review now therefore includes 100 studies and has excluded 147 studies.

This updated review is only focused on two primary outcomes each at two different time points. Of the 31 new studies included in this update, 21 studies provided data for one or more of the primary outcomes (see Table 1). Ten new trials met the inclusion criteria for this review but were excluded from the analyses either because they did not present data in a useable form or because of attrition rates >25%. Eleven studies provided data for outcome 1.1; 13 studies for outcome 1.2; eight studies for outcome 1.3; and eight studies for outcome 1.4. The addition of these studies to the studies included in the previous version of the review meant that for this 2016 update a total of 51 studies contributed data for outcome 1.1; 46 studies for outcome 1.2; 33 studies for outcome 1.3; and 32 studies for outcome 1.4.

Table 1. Summary of included studies from 2016 update
  1. Abbreviations

    ante: antenatally
    N: no
    post: postnatally
    Y: yes

StudyRCT 2-armRCT 3-armRCT 4-armClusterBackground breastfeeding rates (low, medium, high)Type of supporter (professional, lay person, both)Type of support (face-to-face, telephone)Timing of support (antenatal (ante) + postnatal (post), or post alone)Whether support was: proactive (scheduled contacts) or reactive (women needed to request support)Number of postnatal contacts (< 4, 4-8, 9+)Data included in outcome 1Data included in outcome 2Data included in outcome 3Data included in outcome 4
Abbas-Dick 2015x   HighProfessionalFace-to-face and telephonePost aloneProactive< 4NNYY
Bonuck 2014 (BINGO trial)  x MediumProfessionalFace-to-face and telephonePost aloneProactiveUnclearYYYY
Bonuck 2014a (PAIRINGS trial)x   MediumProfessionalFace-to-face and telephoneAnte and postProactiveUnclearYYYY
Bortolini 2012x   HighProfessionalFace-to-facePost aloneProactive9+YYNY
Cameron 2013  x HighProfessionalFace-to-faceAnte and postProactive< 4NNNN
Chapman 2008x   MediumProfessionalFace-to-face and telephoneAnte and postProactive9+NNNN
Edwards 2013x   HighLayFace-to-faceAnte and postUnclear9+NNYN
Efrat 2015x   HighProfessionalTelephoneAnte and postProactive9+NNNN
Elliott-Rudder 2014x  xHighProfessionalFace-to-facePost aloneProactive< 4YYNN
Fu 2014 x xHighProfessionalTelephonePost aloneProactive4 to 8NNYY
Hanson 2015x  xHighLayFace-to-faceAnte and postProactive4 to 8NNNN
Hoddinott 2012x   MediumProfessionalTelephonePostProactive9+NNNN
Howell 2014x   High/lowProfessionalFace-to-face and telephonePostProactive< 4NYNN
Jolly 2012x  xLowLayFace-to-face or telephoneAnte and postProactive4 to 8NNNN
Laliberte 2016x   HighProfessionalFace-to-facePost aloneProactiveUnclearYYNN
Lucchini 2013x   HighProfessionalFace-to-facePostProactive< 4NNNN
McLachlan 2016 x xHighProfessionalFace-to-facePost aloneProactiveUnclearYNNN
McQueen 2009x   HighProfessionalFace-to-face and telephonePost aloneProactive< 4NNYY
Mejdoubi 2014x   HighProfessionalFace-to-faceAnte and postProactive9+YNNN
Ochola 2013 x xHighLayFace-to-faceAnte and postProactive4 to 8NYNY
Paul 2012x   MediumProfessionalFace-to-facePost aloneProactive< 4YYNN
Sikander 2015 x xHighProfessionalFace-to-faceAnte and postProactive4 to 8NYNN
Simonetti 2012x   HighProfessionalTelephonePost aloneProactive4 to 8NYNN
Srinivas 2015x   MediumLayFace-to-face and telephoneAnte and postProactive> 9NNNN
Stockdale 2008x   MediumProfessionalFace-to-faceAnte and postUnclearUnclearNNNN
Tahir 2013x   HighProfessionalFace-to-facePost aloneProactive9+NYYY
Vidas 2011x   UnknownProfessionalFace-to-facePost aloneUnclearUnclearNYNN
Wen 2011x   HighProfessionalFace-to-faceAnte and postProactive4 to 8NYNN
Wilhelm 2015x   HighProfessionalFace-to-facePost aloneProactive4 to 8YNNN
Wu 2014x   UnknownProfessionalFace-to-face and telephonePost aloneProactive< 4NNYN
Yotebieng 2015 x xHighProfessionalFace-to-facePost aloneProactiveUnclearNYNN
               
 25528      111388

In the results section we will not discuss further those studies that did not contribute data to the review, but additional information about these trials is provided in the Characteristics of included studies table and further details about the eleven new trials from the update is also provided in Table 1.

Included studies

This updated review includes 100 trials involving more than 83,246 mother-infant pairs of which 73 studies contribute data (58 individually-randomised trials and 15 cluster-randomised trials).

Description of included studies (n = 73)

Seventy-three of the 100 included studies contribute data to this 2016 update of the review. It should be noted that two of the included trials were obtained via a single publication (Bonuck 2014a); one trial is called the BINGO trial and the other called the PAIRING trial. In order to differentiate between these two trials in this review the BINGO trial is identified via the reference (Bonuck 2014a) and the PAIRING trial via the reference (Bonuck 2014b).

The total number of mother-infant pairs in these studies is 74,656 (this total was 56,451 in the previous version of this review (Renfrew 2012b). The 73 studies were published/conducted between 1979 and 2016 and show increases over time both in number of studies (five studies are dated before 1990, 10 between 1990 and 1999, 40 between 2000 and 2011, and 18 are dated between 2012 and 2016), and range of country settings (the seven studies with dates before 1994 were all undertaken in high-income countries, and the eight studies from low-/low-middle income countries were published in 2000 or later). The data in this review come from participants living in 29 countries. Using the World Bank classification of countries by income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups, accessed 30 June 2016):

1 Note: The Tylleskar study, Tylleskar 2011a, Tylleskar 2011b, and Tylleskar 2011c, was undertaken in three countries, two are in the low-income and one in the upper-middle income World Bank category. In this review, we have entered data into the analyses separately for each country.

Methods used in trials

The 73 studies include 58 individually-randomised trials and 15 cluster-randomised trials (Bhandari 2003; Ekstrom 2006; Elliott-Rudder 2014; Fu 2014; Haider 2000; Hoddinott 2009; Kools 2005; Kramer 2001; Kronborg 2007; McLachlan 2016; Morrow 1999; Ochola 2013; Sikander 2015; Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c; Yotebieng 2015).

Participants and setting
Socioeconomic and health status

Participants were women from the general healthy population of their countries. However, 28 of the 73 studies were undertaken with women from low-income groups within their country. These 28 studies include 16 of the 20 USA studies, with four other studies from high-income countries (Jones 1985; Mejdoubi 2014; Quinlivan 2003; Wen 2011), three of the studies from Brazil (Barros 1994; Coutinho 2005; Vitolo 2005), three of the studies from low-middle income countries (Ochola 2013; Sikander 2015; Yotebieng 2015), and the two studies from low-income countries. In one of these (Haider 2000, Bangladesh), participants were mainly of lower-middle and low socioeconomic status. In the other (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c), participants came from three countries in sub-Saharan Africa, with those in one country (Uganda) from low-income groups within that country. With regard to health of the general population of countries, Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c reported local HIV prevalence rates of 10% to 34% in the South Africa study sites; during recruitment, women who had not been HIV tested were encouraged to visit the antenatal clinic, and those who had HIV-positive status were recruited into another study.

Background rates of breastfeeding initiation/'ever breastfed'

Among the 73 studies, World Bank country income group shows an inverse relationship with background rates of breastfeeding initiation ('ever breastfed'). All the studies with intermediate (60% to < 80%, n = 18) or low (< 60%, n = 11) background rates of breastfeeding initiation were undertaken in high-income countries. Nine of the 11 studies with low background rates recruited women from low-income groups in the USA (Brent 1995; Bonuck 2005; Bunik 2010; Chapman 2004; Di Meglio 2010; Frank 1987; Grossman 1990; Pugh 2002; Serafino-Cross 1992); the remaining two (UK) studies were from areas of Scotland with lower breastfeeding initiation rates than the Scottish average (Hoddinott 2009; Muirhead 2006). All the country income groups are represented among the 24 studies with high (≥ 80%) rates, however the seven studies from low-/low-middle income countries all had high rates. Where background rates of 'ever breastfed' were not reported, we have used either rates published in the WHO Global Data Bank on Infant and Young Child Feeding (www.who.int/nutrition/databases/infantfeeding/countries/en/index; accessed July 2016), or those published in the supplementary material to Victora 2016, and for the two studies from Scotland (Hoddinott 2009; Muirhead 2006), we used www.isdscotlandarchive.scot.nhs.uk/isd/1914 (accessed November 2016). For one study that was conducted in China (Wu 2014), data were not presented in the paper or available in the WHO Global Data Bank on Infant and Young Child Feeding and so were therefore excluded from the sensitivity analysis.

Interventions
Level of the intervention

In 64/73 studies, women received the intervention. In eight studies the intervention was additional training in breastfeeding support for staff (five cluster-randomised trials; Bhandari 2003; Ekstrom 2006; Elliott-Rudder 2014; Kramer 2001; Yotebieng 2015; and three individually-randomised trials; Labarere 2005; Santiago 2003; ISRCTN47056748). One cluster-randomised trial evaluated a policy for providing breastfeeding groups (Hoddinott 2009).

Breastfeeding support: proactive/indirect

In 58 of the 64 studies where women received the intervention and seven of the eight studies of staff training, breastfeeding support was delivered directly to women. However, in two of these studies although the support was offered proactively initially, it was up to the women to request follow-up support (Bonuck 2014a; Laliberte 2016). In five other studies (Graffy 2004; Hoddinott 2009; Labarere 2005; Morrell 2000; Winterburn 2003), breastfeeding support was not offered proactively; women were encouraged to access it, but breastfeeding support was not delivered directly to women as part of these interventions. One study evaluated a multi-faceted intervention, of which breastfeeding support delivered directly to women was one component (Kools 2005). For two studies it was not clear if the support was offered proactively or not (Edwards 2013; Vidas 2011).

One-to-one/group support

In 57 of the 73 studies there was individual, one-to-one contact between the breastfeeding supporter and the breastfeeding mother. Two studies offered group support (Hoddinott 2009; Vidas 2011), one offered both individual and group support (Ekstrom 2006), one study offered support to couples (Abbass-Dick 2015), and in two studies this aspect of support was unclear (Kools 2005; Kramer 2001).

Breastfeeding support from professional/lay supporters

In the previous version of this review, the people providing breastfeeding support were categorised as 'professional', 'lay and professional' or 'lay'. Using those categories, the 73 studies in this update comprise 49 studies of professional support, nine of lay and professional support and 15 of lay support. In view of the growing body of work evaluating breastfeeding peer support, we have distinguished between this and other kinds of lay support, following the definition by Dennis 2002: “Peer support is provided by lay individuals who are not part of the client’s own embedded network, who possess experiential knowledge of the targeted behaviour (i.e. successful breastfeeding skills) and similar qualities (i.e. age, socioeconomic status, ethnicity, residency etc.) in order to aid the client during a time of actual or potential stress (i.e. the initiation and continuation of breastfeeding)."

Professional

In 49 of the 73 studies a variety of medical, nursing and allied professionals (for example, nutritionists, lactation consultants and researchers) provided the breastfeeding support (Abbass-Dick 2015; Albernaz 2003; Bashour 2008; Barros 1994 Bonuck 2005; Bonuck 2014a; Bonuck 2014b; Bortolini 2012; Brent 1995; Bunik 2010; de Oliveira 2006; Di Napoli 2004; Ekstrom 2006; Elliott-Rudder 2014; Frank 1987; Froozani 1999; Fu 2014; Gagnon 2002; Grossman 1990; Howell 2014; Jones 1985; Kramer 2001; Kronborg 2007; Laliberte 2016; Lynch 1986; McLachlan 2016; McDonald 2010; McQueen 2009; McQueen 2011; Mejdoubi 2014; Paul 2012; Petrova 2009; Porteous 2000; Pugh 1998; Quinlivan 2003; Santiago 2003; Serafino-Cross 1992; Sikander 2015; ISRCTN47056748; Sjolin 1979; Su 2007; Tahir 2013; Vidas 2011; Vitolo 2005; Wen 2011; Wilhelm 2015; Wrenn 1997; Wu 2014; Yotebieng 2015).

Professional and lay

Professionals provided breastfeeding support with other people in a further nine studies; para-professionals (Kools 2005; Morrell 2000), peer supporters (Bhandari 2003; Hopkinson 2009; Pugh 2002; Pugh 2010), and lay people (employees who had to be mothers in Barros 1994; someone chosen by the mother in Winterburn 2003; and a group of mothers in Hoddinott 2009).

Lay

Lay people provided breastfeeding support in 17 studies. In twelve of these, the lay people were peer supporters (Chapman 2004; Dennis 2002; Di Meglio 2010; Edwards 2013; Haider 2000; Leite 2005; Morrow 1999; Muirhead 2006; Ochola 2013; Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c). The other five studies did not report that the lay supporters met the Dennis 2002 criteria for us to classify them as peer supporters (Aksu 2011; Coutinho 2005; Graffy 2004; Jenner 1988; Mongeon 1995).

Training in breastfeeding support

Overall, 50 of the 73 studies reported that the people providing breastfeeding support had additional training to provide breastfeeding support (33/49 professional, 3/9 professional and lay, and 14/15 peer/lay). In 10 studies the professionals were International Board Certified Lactation Consultants (IBCLC) (Bonuck 2014a; Bonuck 2014b; Bortolini 2012; Brent 1995; Fu 2014; Laliberte 2016; Petrova 2009; Pugh 1998; Tahir 2013; Yotebieng 2015).

In one of the studies of support from professionals and paraprofessionals, the professionals were lactation consultants (Kools 2005), and in the other they were midwives not stated to have had extra training in breastfeeding support (Morrell 2000); in both these studies the para-professionals were trained to refer women with breastfeeding problems to the professionals. Two of the four studies of support from professionals and peers reported training; in Bhandari 2003 peer supporters received WHO-based training, and in Hopkinson 2009 the professionals were IBCLCs and the peer supporters had three days' training in lactation management, 20 hours' training in peer counselling and at least one year’s work experience. One of the three studies study of professional and lay support stated that lay supporters received breastfeeding support training (Barros 1994).

All 10 studies of peer support (alone) reported that peer supporters were trained. The training was WHO 20 hours (Leite 2005), 40 hours (Haider 2000; Ochola 2013) or one week (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c); La Leche League (LLL) 30 hours (Chapman 2004), 20 hours (Di Meglio 2010); over 30 weeks (Edwards 2013), or not specified (Morrow 1999). Two studies reported the length but not the type of training; 2.5 hours and more than two days (Dennis 2002; Muirhead 2006, respectively). Three of the five studies of lay support (alone) reported breastfeeding training; WHO 18 hours plus five days (Coutinho 2005), WHO 18 hours (Aksu 2011), and National Childbirth Trust training (Graffy 2004).

Mode of support (face-to-face or by telephone, or both)

Forty-seven of the 73 studies offered telephone support and all but two of these were undertaken in countries classified as high-income countries by the World Bank (Albernaz 2003, Brazil; Wu 2014, China). Four studies offered breastfeeding support only by telephone (Bunik 2010; Dennis 2002; Di Meglio 2010; Fu 2014). Thirty offered both face-to-face and telephone support, with telephone support either predominating (e.g. Muirhead 2006; Petrova 2009), or as backup (e.g. Chapman 2004). In some studies (e.g. Kools 2005; Pugh 1998), telephone contact with the breastfeeding support specialist came after the women had been visited by someone else. Across the 27 studies examining telephone support, details about whether or not the telephone support was proactively offered by the peer or professional supporter were not reported consistently. Thirty-eight studies offered only face-to-face support. In the one remaining study (Winterburn 2003), the support was not proactive and the mode of support was not specified.

Support with an antenatal component and intention to breastfeed

The outcomes of interventions intended to promote longer duration of breastfeeding could be expected to differ according to whether women were recruited before or after they started to breastfeed. Two-thirds of the studies (49/73) included postnatal women at or after initiation of breastfeeding. In the one study of breastfeeding in groups (Hoddinott 2009), pregnant women and breastfeeding mothers could be invited to attend groups. The remaining 24 studies recruited women before the birth, not all of whom went on to initiate breastfeeding. Six of the 24 studies included only women who intended to breastfeed (Kramer 2001 in Belarus; Jenner 1988 and Winterburn 2003 in the UK; Serafino-Cross 1992 in the USA; Mongeon 1995 in Canada; Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c in Burkina Faso, Uganda and South Africa). In the Tylleskar 2011 study, this inclusion criterion was related to HIV/AIDS prevention and management in the country and study populations. The other studies that recruited before the birth did not specify that participants had to intend to breastfeed.

Intensity of the intervention

Sixty of the 73 studies reported the intensity of the intervention in terms of the number of postnatal contacts the mother could have for breastfeeding support. Twenty-four studies specified three or fewer contacts, 21 specified four to eight contacts, and the remaining 17 studies specified nine or more contacts. We have performed a subgroup analysis and the results are described in the text.

Control group care

Seven of the 73 studies were undertaken in hospital settings with Baby Friendly accreditation (Aksu 2011; Chapman 2004; Coutinho 2005; de Oliveira 2006; ISRCTN47056748; Tahir 2013; Yotebieng 2015). However, in the study by Yotebieng 2015, the intervention was the Baby Friendly Hospital Initiative (BFHI) so the control group did not access this. For the other six studies undertaken in settings with Baby Friendly accreditation, study interventions were additional to care that met Baby Friendly standards and were received by everyone at the hospital including all the study participants in the intervention and control groups. In two community-based cluster-randomised trials (Hoddinott 2009; Kronborg 2007), most of the maternity hospitals in which the participants had given birth had Baby Friendly accreditation.

In 29 studies control group care was not specified (n = 9) or stated to be standard care but not described (n = 20). In the remaining studies there was some description of control group care (see Characteristics of included studies). Standard postnatal care varies both between and within countries. Care may have differed within the study period and may also have differed from that which is offered at the present time.

Outcomes
Level of data collection

In 66 of the 73 studies outcome data were collected from the women who had received the intervention. In the other seven studies, the relationship between the recipients of the intervention and the source of the outcome data varied. In the three individually-randomised trials of staff training (ISRCTN47056748; Labarere 2005; Santiago 2003), outcome data came from all the women randomised to receive, or not to receive, a support intervention from trained staff. In one of the three cluster-randomised trials of staff training (Ekstrom 2006), data came from mothers of singleton term healthy infants at centres where staff had been randomised, or not randomised, to receive training. In another (Bhandari 2003), trained staff visited all families in the intervention villages and outcome data were collected from all infants in the intervention and control villages, and in the third (Kramer 2001), staff in all intervention sites were trained and data were collected from mothers who intended to breastfeed in the intervention and control sites. In the cluster-randomised trial that evaluated a policy for providing breastfeeding groups (Hoddinott 2009), the policy intervention was made at locality level. Pregnant or postnatal women could be invited to groups in intervention clusters; however, only 1310 pregnant or breastfeeding women out of more than 9000 births in the intervention localities attended any group.

Duration of any and/or exclusive breastfeeding

Breastfeeding duration was most commonly assessed at six months. A total of 51 studies measured any breastfeeding at six months and 46 studies measured exclusive breastfeeding at six months. For the other primary outcomes, 33 studies measured any breastfeeding at four to six weeks and 32 measured exclusive breastfeeding at four to six weeks. When data on both seven-day and 24-hour recall were provided, we selected the data for 24-hour recall.

The breastfeeding outcomes reported reflect World Bank country income group of the countries in which the 73 studies were undertaken. Most studies (29/52) reported the effect of the intervention on rates of both any and exclusive breastfeeding. Some studies report details about data collection that make it clear that duration of exclusive breastfeeding at specific time points was not necessarily measured from birth (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c; Vitolo 2005); most studies did not report this level of detail.

Secondary outcomes

Details of secondary outcomes were not collected for this update but will be included in the next update in two years time.

In the previous version of this review (Renfrew 2012b), a few studies reported various infant morbidity and maternal satisfaction with feeding and care outcomes by intervention group: infant morbidity was reported in 11 studies (Bashour 2008; Bhandari 2003; Bunik 2010; Frank 1987; Froozani 1999; Kramer 2001; Morrow 1999; Petrova 2009; Pugh 2002; Quinlivan 2003; Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c); maternal satisfaction with feeding in 11 studies (Bashour 2008; de Oliveira 2006; Dennis 2002; Hoddinott 2009; Hopkinson 2009; Kronborg 2007; Labarere 2005; McDonald 2010; McQueen 2011; Petrova 2009; Pugh 1998), and maternal satisfaction with care in six studies (Bashour 2008; Ekstrom 2006; Graffy 2004; Jones 1985; Kools 2005; Morrow 1999).

 

Excluded studies

The previous version of this review excluded 79 studies from the review and we have excluded a further 68 studies. Thus 147 studies have been excluded with reasons (see Characteristics of excluded studies). The main reason for exclusion was because studies were not randomised trials, or it was not clear that allocation to groups had been carried out randomly; we excluded 18 studies identified by the search for this reason (Caulfield 1998; Davies-Adetugbo 1996; Ebbeling 2007; Garcia-Montrone 1996; Hall 2007; Jang 2008; Kistin 1994; McInnes 2000; Moreno-Manzanares 1997; Neyzi 1991; Nor 2009; Pascali-Bonaro 2004; Perez-Escamilla 1992; Segura-Millan 1994; Sisk 2006; Susin 2008; Thussanasupap 2006; Valdes 2000). A further two papers were reviews rather than reports of a randomised controlled trials (Guise 2003; Lewin 2005).

We excluded 72 trials because the intervention was not relevant to this review. We excluded 42 trials on the grounds that studies examined educational interventions where the focus was on instruction rather than on support to women to encourage breastfeeding (Ahmed 2016; Beiler 2011; Benitez 1992; Bolam 1998; Cattaneo 2001; Christie 2011; Edwards 2013a; Ehrlich 2014; Finch 2015; Flax 2014; Forster 2004; Giglia 2015; Girish 2013; Hanafi 2014; Harari 2014; Hauck 1994; Henderson 2001; Isselmann 2006; Jakobsen 2008; Jones 2004; Labarere 2003; Labarere 2011; Lavender 2004; Louzada 2012; Mattar 2003; Perez-Blasco 2013; Phillips 2011; Pollard 1998; Rea 1999; Rossiter 1994; Sakha 2008; Schy 1996; Svensson 2013; Szucs 2015; Tully 2012; Vianna 2011; Vitolo 2012; Vitolo 2014; Wallace 2006; Wan 2011; Westphal 1995; Williams 2014). We excluded a further 13 trials as the intervention was not designed to support continued breastfeeding; these studies examined more general interventions in the postnatal period (Ball 2011; Barlow 2006; Barnet 2002; Black 2001; Gagnon 1997; MacArthur 2002; Peterson 2002; Pollard 2011; Ratner 1999; Rush 1991; Serrano 2010; Thomson 2009; Wiggins 2005); a further trial by Baqui 2008 focused on breastfeeding initiation only, rather than on postnatal support to encourage continuation. Eleven of the studies examined interventions carried out in the antenatal period only, and had no postnatal support component (Forster 2006; Jahan 2014; Johnston 2001; Katepa-Bwalya 2011; Kronborg 2012; MacArthur 2009; Olenick 2011; Otsuka 2012; Noel-Weiss 2006; Reeve 2004; Wockel 2009).

We excluded 25 of the studies that we assessed for inclusion as they did not focus on healthy mothers with healthy, term infants. Five trials examined interventions for low birthweight babies (Agrasada 2005; Brown 2008; Junior 2007; Pinelli 2001; Thakur 2012), while the Ahmed 2008 study recruited only mothers of premature babies. The Davies-Adetugbo 1997 and Haider 1996 studies recruited the mothers of babies with severe diarrhoea, the Merewood 2006, Phillips 2010 and Phillips 2012 studies recruited only mothers of babies admitted to neonatal intensive care units, and the Pound 2015 study only included babies with jaundice. The Ferrara 2008 and Stuebe 2016 trials focused on an intervention for mothers with diabetes, the Martin 2015 and Carlsen 2013 studies focused on overweight women, and the Gijsbers 2006 and Mesters 2013 trials on families with a history of asthma, while Moore 1985 looked at infants with a parent with eczema or asthma. Three other trials recruited only women in high-risk groups (Chapman 2011; McLeod 2003; Rasmussen 2011). Two studies focused providing support for fathers (Byas 2011; Tohotoa 2012), and one study concerned training for student nurses (Davis 2014).

The remaining trials were excluded for other reasons (Bica 2014; Finch 2002; Haider 2014; Hives-Wood 2013; Hoddinott 2012a; Lieu 2000; Mannan 2008; Nkonki 2014; Nor 2012; Ochola 2013a; Penfold 2014; Rasmussen 2011; Rowe 1990; Sciacca 1995; Steel O'Connor 2003; Thakur 2012; Wasser 2015). Further details of these, and other excluded studies, can be found in the Characteristics of excluded studies tables.

Risk of bias in included studies

Each trial was assessed for methodological quality as outlined in the Methods section (see Figure 1 and Figure 2).

Allocation

Random sequence generation: we considered that a little over half of the studies included in the review used methods that were at low risk of bias to generate the randomisation sequence: we deemed 54 studies to be at low risk; nine studies at high risk and 38 studies to be at unclear risk.

Allocation concealment: we considered that a little less than half of the studies included in the review used methods that were at low risk of bias to conceal allocation to experimental groups: we deemed 44 studies to be at low risk; nine studies at high risk and 48 studies to be at unclear risk.

Blinding

Blinding participants and personnel: with interventions of this type, it is very difficult to assess risk of bias associated with blinding. Both the mothers and the staff providing care would probably be aware that they were either receiving or delivering an intervention. In studies where there was randomisation at the clinic level, all women may have been exposed to the same intervention, and contamination between groups would thereby be reduced, but there may still have been a risk of response bias if outcomes were reported to staff providing care. Therefore, we assessed no studies as being at a low risk of bias for this domain.

Blinding of outcome assessment: we assessed approximately one-quarter of studies as being at low risk of bias for blinding of outcome assessment: we deemed 27 studies to be at low risk, 27 studies to be at high risk, and 47 studies at unclear risk.

Incomplete outcome data

We had prespecified that we would not include data for any outcome where there were missing data for more than 25% of the randomised group. Loss to follow-up was a particular problem in studies where women were recruited in the antenatal period and, as we have described above, we have not included any outcome data from studies that were otherwise eligible for inclusion in the review because of high levels of attrition for all outcomes. For some of those studies that contributed data there was still considerable loss to follow-up, and loss was not always balanced across randomisation groups. When assessing incomplete outcome data, reasons for loss of data were not taken into consideration.

We judged approximately one-third of studies to be at low risk of bias for incomplete outcome data: we deemed 36 studies to be at low risk; 18 studies at high risk and 47 studies to be at unclear risk.

Selective reporting

We assessed bias in most of the studies included in the review from published study reports. In most cases we did not have access to the trial registration or protocol. Under these circumstances assessing risk of bias due to selective reporting bias is very difficult. For this reason in the last version of this review all of the studies were deemed to be at unclear risk of bias for this domain. In this update we were able to access some protocols for newly included studies. Only 10 studies have been assessed as being at low risk of bias; five studies as high risk of bias and 86 studies as unclear.

Other potential sources of bias

We have noted any other concerns about bias (including any apparent baseline imbalance between randomised groups) in the Characteristics of included studies tables along with further information about the judgements we made about risk of bias for each included study. The quality of the studies was very mixed and most of the studies had some methodological weakness, or did not provide good information about methods. It is important that the mixed quality of the evidence is taken into account in the interpretation of results. We judged 28 studies to be at low risk of other potential sources of bias; six studies at high risk of bias and 67 studies at unclear risk.

Effects of interventions

See: Summary of findings for the main comparison All forms of support versus usual care

Interventions to support breastfeeding versus usual care: 73 studies

Primary outcomes
Outcome 1.1: Stopping any breastfeeding up to six months postpartum

The main summary outcome measure was cessation of any breastfeeding at the time of the last study assessment up to six months (Analysis 1.1).

In the meta-analysis for this outcome the previous version of this review we included 40 trials with 14,227 women (effective sample size). With the new studies we added in this update, there are now 51 studies with 21,418 women included. One new study (the BINGO trial, Bonuck 2014a), contributes two intervention arms to the analysis and the control group was split to avoid double counting. One of the cluster-randomised trials (McLachlan 2016) also contributed two intervention arms and splitting over the control group was included in the adjustment for clustering.

Interventions to support breastfeeding appear to have a beneficial effect on the number of women who continue breastfeeding beyond six months, with fewer women in the groups that receive support stopping breastfeeding by this time (average risk ratio (RR) 0.91, 95% confidence interval (CI) 0.88 to 0.95;moderate-quality evidence). Overall, 52.59% of those receiving support interventions had stopped any breastfeeding by six months compared with 56.64% of controls (unweighted percentages). However, there was high heterogeneity for this outcome and results should therefore be interpreted with caution (heterogeneity: Tau² = 0.01, I² = 55%, Chi² = 116.09, P < 0.00001).

Sensitivity analysis using only studies assessed as having a low risk of bias for allocation concealment demonstrated a similar positive treatment effect on breastfeeding at up to six months (Analysis 1.5). A sensitivity analysis omitting the cluster-randomised study (Elliott-Rudder 2014) for which a design effect could not be calculated demonstrated a similar positive treatment effect (average RR 0.91, 95% CI 0.88 to 0.94).

Visual inspection of the funnel plot generated for this outcome suggested that there was some asymmetry with results from smaller studies tending to show a greater positive treatment effect (Figure 3).

Figure 3.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.1 Stopping breastfeeding (any) before last study assessment up to 6 months

Outcome 1.2: Stopping exclusive breastfeeding up to six months postpartum

In the previous version of this review we included 33 studies with 11,961 women in the analysis of women who had stopped exclusive breastfeeding at up to six months. With the new studies we added in this update, there are now 46 studies with 18,591 women included. Two new studies (the BINGO trial, Bonuck 2014a;Yotebieng 2015), contribute two intervention arms to the analysis; we split the control group to avoid double-counting.

Women in the intervention groups were less likely to have stopped exclusive breastfeeding before six months (average RR 0.88, 95% CI 0.85 to 0.92; moderate-quality evidence) (Heterogeneity: Tau² = 0.01, I² = 96%, Chi² = 1076.75, P<0.00001; Analysis 1.2); although 74.9% of women in the intervention groups had stopped exclusive breastfeeding by this time, a greater proportion of women in the control groups had stopped (83.4%; unweighted percentages).

Sensitivity analysis using only those studies assessed as having a low risk of bias for allocation concealment revealed that results still significantly favoured the intervention groups (Analysis 1.6), although the effect size was reduced in the studies at low risk of bias (average RR 0.93, 95% CI 0.89 to 0.96). A sensitivity analysis omitting the one arm of the cluster-randomised study (Yotebieng 2015) for which a design effect could not be calculated demonstrated the same positive treatment effect (average RR 0.88, 95% CI 0.84 to 0.91).

Visual examination of a funnel plot for this outcome suggested that the treatment effect may have been more pronounced in smaller studies (Figure 4).

Figure 4.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.2 Stopping exclusive breastfeeding before last study assessment up to 6 months

Outcome 1.3: Stopping any breastfeeding before four to six weeks postpartum

In the previous version of this review we included 25 studies with 8513 women in the analysis of women stopping breastfeeding before four to six weeks. With the new studies we added in this update, there are now 33 studies with 10,776 women included. Two new studies (the BINGO trial, Bonuck 2014a; Fu 2014), contribute two intervention arms to the analysis, and we have split the control arm to avoid double-counting.

Women receiving support interventions were less likely to stop breastfeeding before six weeks (average RR 0.87, 95% CI 0.80 to 0.95; moderate-quality evidence): while 31.3% of women in the intervention groups had stopped exclusive breastfeeding by this time, 34.8% of women in control groups had also stopped (unweighted percentages). There was considerable variation in the results from individual studies (heterogeneity: Tau² = 0.02, I² = 54%, Chi² = 74.65, P = 0.0001; Analysis 1.3).

Sensitivity analysis using only those studies assessed as having a low risk of bias for allocation concealment revealed that results still significantly favoured the intervention groups (Analysis 1.7), although the effect size was reduced in the studies at low risk of bias (average RR 0.88, 95% CI 0.81 to 0.96).

Visual examination of a funnel plot for this outcome suggested that the treatment effect may have been more pronounced in smaller studies (Figure 5).

Figure 5.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.3 Stopping breastfeeding (any) at up to 4-6 weeks

Outcome 1.4: Stopping exclusive breastfeeding before four to six weeks postpartum

In the previous version of this review, we included 24 studies with 7693 women in the analysis of women who had stopped exclusive breastfeeding before four to six weeks. With the new studies we added in this update, there are now 32 studies with 10,960 women included. Two new studies (the BINGO trial, Bonuck 2014a; Fu 2014), contribute two intervention arms to the analysis, and we have split the controls to avoid double-counting.

Women in the intervention groups were less likely to stop exclusive breastfeeding by six weeks compared with women in the control groups (average RR 0.79, 95% CI 0.71 to 0.89; moderate-quality evidence); and while 57.2% of women in the intervention groups had stopped exclusive breastfeeding by this time, 65.0% of women in control groups had also stopped (unweighted percentages); (heterogeneity: Tau² = 0.10, I² = 97%, Chi² = 1160.22, P < 0.00001; Analysis 1.4).

Again, there was some evidence that the treatment effect may be partly due to bias; sensitivity analysis including only those studies assessed as being at low risk of bias for allocation concealment showed that results still favoured the intervention group although the treatment effect was less pronounced in the studies at lower risk of bias (Analysis 1.8). A sensitivity analysis omitting the cluster-randomised study (Ochola 2013) for which a design effect could not be calculated demonstrated a similar positive treatment effect (average RR 0.80, 95% CI 0.71 to 0.89).

Visual examination of the funnel plot for this outcome suggested that the treatment effect may have been more pronounced in smaller studies and that there may be smaller studies missing which do not find an effect in favour of the intervention (Figure 6).

Figure 6.

Funnel plot of comparison: 1 All forms of support versus usual care, outcome: 1.4 Stopping exclusive breastfeeding at up to 4-6 weeks

Secondary outcomes

This update of the review does not include an analysis of secondary outcomes.

Secondary outcomes were not considered in this update so that the review could be completed in time to inform the World Health Organisation’s review of the evidence and update of the WHO recommendations on breastfeeding in maternity facilities. A new set of core outcomes for Cochrane pregnancy and childbirth breastfeeding reviews is currently being developed and the outcomes from this core set may influence future outcomes chosen for this review.

Subgroup analysis

There was considerable variation between the trials in terms of the interventions examined, the standard care offered to women, and the background breastfeeding initiation rates in the various study settings. We wanted to explore whether different types of support and settings were associated with different or more pronounced treatment effects. Therefore, for the review's four primary outcomes we carried out subgroup analysis to explore the impact of interventions involving different types of supporter (professional versus lay person, or both); types of support (face-to-face versus telephone support or both); timing of support (antenatal and postnatal versus postnatal alone); whether the support was proactive (scheduled contacts) or reactive (women needed to request support); and whether support interventions had similar effects in settings with different background breastfeeding initiation rates (low, medium or high background rates).

For all subgroup analyses, the covariate chosen does little to explain the high heterogeneity; most within-group heterogeneity remains high.

Who delivered the support

For our four primary outcomes, we examined whether the treatment effect was similar where the support was delivered by professionals as opposed to non-professionals (lay support) or both. It should be noted that most studies involved delivery of the intervention by professionals (37 of the 51 studies).

For cessation of any breastfeeding at up to six months it appeared that support from non-professionals was associated with a broadly similar treatment effect to that for support from professionals (Analysis 2.1).

The test for subgroup differences suggests a differential treatment effect according to who delivers the support, but we are not confident in this result due to very different subgroup sizes and high within-group heterogeneity in two of three groups and zero heterogeneity in the other (test for subgroup differences: Chi² = 6.02, degrees of freedom (df) = 2 (P = 0.05), I² = 66.8%). When the smaller, mixed support group is removed from the analysis, there is no evidence of a difference between lay and professional support (test for subgroup differences: Chi² = 2.89, df = 1 (P = 0.09), I² = 65.4%).

For cessation of exclusive breastfeeding at up to six months the treatment effect appears to be greater when the intervention was delivered by non-professionals (lay support) compared with professionals or mixed support (test for subgroup differences: Chi² = 7.74, df = 2 (P = 0.02), I² = 73.1%; Analysis 2.2). The confidence intervals for professional and lay support do not overlap, but due to the high heterogeneity remaining within the subgroups, we advise caution when interpreting this result.

For cessation of any breastfeeding by four to six weeks there is no evidence for a differential effect when professionals, lay or both deliver support (test for subgroup differences: Chi² = 1.47, df = 2 (P = 0.48), I² = 0%; Analysis 2.3).

For cessation of exclusive breastfeeding by four to six weeks the test for subgroup differences indicates a possible differential treatment effect (test for subgroup differences: Chi² = 7.12, df = 2 (P = 0.03), I² = 71.9%). However, we are not confident in this result, because the mixed subgroup is disproportionately small. When this third group is removed from the analysis there is no evidence for a differential effect between professional and lay support test for subgroup differences: Chi² = 2.31, df = 1 (P = 0.13), I² = 56.7%; Analysis 2.4).

Type of support

We compared different types of intervention (support provided predominantly by face-to-face contact, predominantly by telephone, or by both face-to-face and telephone contact) for our primary outcomes.

For cessation of any breastfeeding at up to six months there was no evidence of a differential effect according to type of support (test for subgroup differences: Chi² = 0.40, df = 2 (P = 0.82), I² = 0%; Analysis 3.1).

For cessation of exclusive breastfeeding at up to six months face-to-face interventions may be associated with greater effects than other types of support; however, very high within-group heterogeneity remains in the analysis, and we advise caution when interpreting this result (test for subgroup differences: Chi² = 37.55, df = 2 (P<.00001, I² = 94.7%; Analysis 3.2).

For cessation of any breastfeeding by four to six weeks, there is no evidence of a differential effect according to type of support (test for subgroup differences: Chi² = 0.91, df = 2 (P = 0.64), I² = 0%; Analysis 3.3).

For cessation of exclusive breastfeeding at up to four to six weeks, face-to-face interventions may be associated with greater effects than other types of support; however very high within-group heterogeneity remains in the analyses, and we advise caution when interpreting this result (test for subgroup differences: Chi² = 10.63, df = 2 (P = 0.005), I² = 81.2%; Analysis 3.4).

When the support was offered

We examined whether offering support with an antenatal component rather than postnatal support alone was associated with any difference in treatment effect. The results were similar in both subgroups for all of our four primary outcomes and there were no significant subgroup differences according to the interaction tests (Analysis 4.1 test for subgroup differences: test for subgroup differences: Chi² = 0.15, df = 1 (P = 0.70), I² = 0%); (Analysis 4.2 test for subgroup differences: Chi² = 1.54, df = 1 (P = 0.21), I² = 35.1%); (Analysis 4.3 test for subgroup differences: Chi² = 1.05, df = 1 (P = 0.31), I² = 4.4%); (Analysis 4.4 test for subgroup differences: Chi² = 2.07, df = 1 (P = 0.15), I² = 51.6%).

Proactive versus reactive support

We had planned to carry out formal subgroup analysis by whether support was proactive or reactive, but due to the fact that most interventions included at least one scheduled contact (proactive), we did not think that this way of categorising studies would shed light on types of interventions that were effective or ineffective.

Background breastfeeding initiation rates in study settings

We were interested in whether or not background rates of breastfeeding in different settings had any impact on the success of interventions. We divided the studies into three groups: those carried out in settings where 80% or more women initiated breastfeeding (high background initiation), where between 60% to 80% initiated breastfeeding (intermediate) or where breastfeeding initiation rates were less than 60% (low). These groups showed an inverse relationship with World Bank country income groups. The studies with high background rates of breastfeeding initiation were set in countries from all the World Bank country income groups, however, the four studies from low-/low-middle income countries had the highest rates (more than 95%). All the studies with intermediate or low background rates of breastfeeding initiation were undertaken in high-income countries.

We found the interventions had a greater effect of preventing women stopping exclusive breastfeeding at both time points in countries where background rates were already high; there was no similar effect on any breastfeeding. Because within-group heterogeneity remains high in all analyses, we advise caution when interpreting this result.

For cessation of any breastfeeding at up to six months, there is no evidence of a difference in the effectiveness of the intervention according to the background breastfeeding rate (test for subgroup differences: Chi² = 0.56, df = 2 (P = 0.76), I² = 0%; Analysis 5.1).

For cessation of exclusive breastfeeding at up to six months, the intervention effect appears greater in studies where breastfeeding initiation rates were high (test for subgroup differences: Chi² = 30.73, df = 2 (P <.00001, I² = 93.5%; Analysis 5.2). However, within-group heterogeneity remains very high, and we advise caution when interpreting this result.

For cessation of any breastfeeding by four to six weeks, there is no evidence that the interventions worked differently in trials with different background rates of breastfeeding (test for subgroup differences: Chi² = 2.72, df = 2 (P = 0.26), I² = 26.6%; Analysis 5.3).

For cessation of exclusive breastfeeding at up to four to six weeks, the intervention effect appears stronger in studies where initiation rates were high (test for subgroup differences: Chi² = 9.24, df = 2 (P = 0.010), I² = 78.4% Analysis 5.4). However, within-group heterogeneity remains very high in all subgroups, and we advise caution when interpreting this result.

Intensity of the intervention: the number of postnatal contacts

We examined whether different numbers of postnatal contacts were associated with any difference in treatment effect. We divided the studies into four subgroups: unspecified or no direct contacts (for example in studies that involved staff training rather than direct contacts with women); less than four postnatal contacts; between four and eight contacts; and more than eight contacts. Trials including antenatal contacts are included here, and we used the number of postnatal contacts to determine the appropriate subgroup.

For cessation of any breastfeeding at the final study assessment up to six months, there was no evidence of subgroup differences (test for subgroup differences: Chi² = 1.45, df = 3 (P = 0.69, I² = 0%; Analysis 6.1).

For cessation of exclusive breastfeeding at up to six months, there appears to be a differential effect of the number of postnatal contacts, with four to eight contacts performing best. The confidence intervals for this subgroup do not overlap with any other subgroup, but within-group heterogeneity for all subgroups remains very high, and we advise caution when interpreting this result (Analysis 6.2; test for subgroup differences: Chi² = 13.78, df = 3 (P = 0.003), I² = 78.2%).

For cessation of any breastfeeding by four to six weeks, there was no evidence of a differential treatment effect according to the number of postnatal contacts (test for subgroup differences: Chi² = 1.59, df = 3 (P = 0.66), I² = 0%; Analysis 6.3).

For cessation of exclusive breastfeeding at up to four to six weeks there appears to be differential treatment effect according to the number of support contacts, with four to eight contacts the most effective schedule. However, within-group heterogeneity remains very high in all subgroups, and we advise caution when interpreting this result (test for subgroup differences: Chi² = 7.62, df = 3 (P = 0.05), I² = 60.6%; Analysis 6.4).

Discussion

Summary of main results

This update of the review considered the evidence of the effect of breastfeeding support interventions on primary outcomes of stopping any or exclusive breastfeeding before four to six weeks and at up to six months postpartum. The review includes 100 trials published from 1979 to 2016, 73 of which contributed data to the analyses. The 73 trials that contributed data to the analyses were conducted in 29 countries; 52 studies (62.1% of participants) in high-income countries, 15 (30.1% of participants) in upper-middle income countries, four (3.4% of participants) in lower-middle income countries, and four (4.4% of participants) in low-income countries. The numbers of trials include one (Tylleskar 2011a; Tylleskar 2011b; Tylleskar 2011c) that was conducted in three countries; two low-income and one upper-middle income countries. This number and location of trials indicates that the challenge of supporting women to breastfeed is both longstanding and international; this is also reflected in the continuing low rates of duration and exclusivity of breastfeeding in many countries, despite increasing availability of good-quality evidence of the scale of its public health impact.

This updated review provides evidence that interventions to support breastfeeding appear to reduce the risk of women stopping any breastfeeding at up to six months and exclusive breastfeeding at up to six months. Similarly the review provides evidence that women receiving breastfeeding support interventions were less likely to stop any breastfeeding before six weeks and exclusive breastfeeding at up to four to six weeks. The size of the treatment effects varied considerably in different trials, and average treatment effects may not be applicable in different settings. The subgroup analyses suggested that face-to-face support was associated with a greater treatment effect for exclusive breastfeeding than either telephone support alone or mixed telephone and face-to-face support. Similarly, support interventions were associated with greater effect on exclusive breastfeeding in settings with high background breastfeeding initiation rates compared to settings with low or intermediate breastfeeding initiation rates. Lay support and more contact in the form of scheduled visits (4 to 8 visits) were also associated with greater treatment effects.  However, for all of these subgroup results, the within-group heterogeneity remains high, and we advise caution when interpreting these results.

A striking aspect of this updated review is the heterogeneity of the support interventions, and the diversity of settings and of standard care. Interventions deemed by researchers to be ‘supportive’ included some where it was difficult to see how women might actually feel supported, especially when the support service provided was one they had to ask for, or travel a distance to get to (Graffy 2004; Hoddinott 2009), or where there was only one scheduled contact with the support person. However, this updated review, like the previous update (Renfrew 2012b), has shown that the effect of supportive interventions is robust across settings and population groups, and results from a wide range of interventions. 

Overall completeness and applicability of evidence

This review adds 21 trials contributing data to its evidence base compared to its predecessors (Britton 2007; Renfrew 2012b; Sikorski 2002). The number of mother-infant pairs in these studies has increased to 74,656 from 56,451 in Renfrew 2012b. The reporting of the included studies was, however, often not comprehensive - lacking, for example, in terms of a description of the components of the support intervention, details of the training and qualifications of the supporters, the definitions used of the extent of breastfeeding and in the description of adherence to the support protocol. There was also a failure to present details of the interventions and of the standard care available to both intervention and comparison groups. Very few of the trials described a theoretical basis for the intervention tested, with the result that the findings are difficult to explain or to replicate. There has been slight improvement in study reporting or quality, with 44 out of the 73 trials that contributed data (60%) reporting an approach to allocation concealment that we considered to be at low risk of bias compared to 26 of the 52 trials (50%) in the previous review (Renfrew 2012b).

It is possible that not all existing trials have been included in this meta-analysis. Funnel plot analyses conducted for the primary outcomes all show marked asymmetry, with each suggesting that smaller studies showing a less beneficial effect of the intervention may be missing. This may be the result of publication bias although it is also possible that few or no such trials exist. Nevertheless, caution should be taken when interpreting the evidence as funnel plot asymmetry can also be the result of heterogeneity.

Interventions offered across all included studies were very diverse, as was the provision of standard care. Interventions included, for example, one individual session in hospital, offering women the opportunity to attend a group session in community settings, telephone support, and multiple one-to-one visits at home over several months. Five studies offered the intervention in the context of Baby Friendly accreditation of the hospital, and are unlikely to be generalisable to settings where this standard of care is not available to all women.

Study endpoints also varied widely, with some substantial gaps of many months between the completion of the intervention and the last study outcome assessed. Many only offered support in the early days or weeks. These factors, together with the range of different settings and population subgroups studied, should urge caution in the interpretation of the analysis of pooled data.

Despite this caution, the overall benefit identified from all forms of support interventions has been explored with subgroup and sensitivity analyses and is moderately robust following exclusion of the methodologically weaker trials. In this review, the greatest effect of breastfeeding support interventions on reducing cessation of exclusive breastfeeding before six months occurred in communities with high (over 80%) levels of breastfeeding initiation. This suggests that work to promote breastfeeding at a population level should continue as one strategy to increase breastfeeding duration and exclusivity (Dyson 2009; Rollins 2016).

While the effect size of support interventions on reducing the cessation of any breastfeeding is modest, there is evidence of a greater effect on the prolongation of exclusive breastfeeding. There was a reduction in the cessation of exclusive breastfeeding within the first six months and at up to four to six weeks when lay support was used, although in view of considerable within-subgroup heterogeneity, these findings should be interpreted with caution.

We have explored a range of possible reasons to explain the significant heterogeneity in the findings. As noted above, included studies were very varied in setting, population group studied, content, timing and intensity of the intervention, whether it was proactively offered to women or available only if they asked for it, the standard care available, staff training programmes, and the type and timing of the outcomes measured.

Strategies that depend mainly on face-to-face support appear more effective than those that rely primarily on telephone contact for women who practice exclusive breastfeeding. The duration of the intervention also seems to be an important factor for exclusive breastfeeding. Interventions that relied on one session in hospital are very different from interventions where women receive repeated home visits. We attempted to examine this by assessing the intensity of the intervention, and we found studies with four to eight visits to be associated with a more pronounced treatment effect on exclusive breastfeeding at final study assessment. However there was some evidence that more pronounced treatment effects were associated with studies at higher risk of bias; this could potentially confound any differences between subgroups. Caution is also needed in the interpretation of this finding as there is inconsistent reporting due to variations in the timing of outcome assessments, and the settings of studies and the population groups included in studies with more face-to-face visits. There was no evidence found for a difference between solely postnatal interventions and those interventions with both an antenatal and postnatal component.

It is likely that support will be most effective when it reflects the local needs of the population. It was notable that none of the five studies where women were expected to access support without any proactive element found a difference in outcomes between control and intervention groups. Four of these five were UK-based studies, which may help to explain the lack of effect seen in recent UK trials (Hoddinott 2011).

The findings of the subgroup analysis that suggests that interventions with four to eight contacts are best compared to those with either fewer contacts or nine or more contacts seems counter-intuitive. Given the heterogeneity of the somewhat complex interventions being tested, however, we might assume that it is other aspects of the interventions that may be responsible. One of the ways to test this would be to conduct meta-regression of the effects of the number of contacts; thus ensuring that the exact number of contacts is used for each study rather than the categorization we have used. This is something we will explore in a future update of this review. We will also consider, in a future update, adopting an analysis strategy which would treat the outcomes as time-to-event data (i.e. 'time to breastfeeding cessation' and 'time to cessation of exclusive breastfeeding'). However, whilst some studies do provide such data, many currently do not.

Quality of the evidence

We considered that the overall risk of bias of trials included in the review was mixed. We graded fewer than half of the studies (44/100) as being at low risk of bias for allocation concealment. However, when we carried out sensitivity analysis which included only those studies at low risk of bias for allocation concealment, the results were not substantially different. A potentially important source of bias in these studies was the general lack of blinding. However, given the nature of the intervention it is unlikely that participants or personnel, or both, would be blinded, as for the support interventions, trialists would face considerable difficulties in blinding staff and women. We graded blinding of outcome assessment as being at low risk in about a quarter of studies. However, even where an attempt is made to blind outcome assessment, there is still a risk of response bias for outcomes relying on self-report such as any or exclusive breastfeeding. A further possible source of bias was loss to follow-up and missing outcome data. In the 17 studies with an attrition of more than 25%, the reasons for attrition were unclear, and these studies did not contribute data to the review. However, we are aware that even lower levels of attrition are problematic, particularly where loss was not balanced across different arms of trials. To avoid problems associated with attrition, we carried out intention-to-treat analysis for our primary outcomes; that is, we assumed that all women who were lost to follow-up had stopped breastfeeding by given time points. This is likely to have diluted overall treatment effects but these estimates may be more appropriate given the possibility of response bias and the increased likelihood of women who stopped breastfeeding dropping out before those who continued.

We assessed the four primary outcomes with GRADE criteria. We did not downgrade any evidence for lack of blinding during this assessment; neither did we downgrade trials for other risk of bias domains (our sensitivity analyses were robust, as reported above). We judged all outcomes to be of moderate quality - stopping 'any' breastfeeding at up to six months; 'any' breastfeeding between four to six weeks; stopping exclusive breastfeeding at up to six months; or stopping exclusive breastfeeding between four to six weeks; all analyses had substantial heterogeneity even with a random-effects model. An assessment of moderate quality highlights our uncertainty in the summary estimate presented here. Included trials of breastfeeding support had mixed results for preventing women from stopping exclusive breastfeeding.

In meta-analyses with a large number of trials, as is the case in this review, there is a strong possibility that a large number of small and possibly poor quality trials will have a substantial influence on the result. In such circumstances it is preferable, therefore, to conduct a sensitivity analysis confined to the trials of the best methodological quality, which would be assumed to be the most reliable and unbiased. Apart from allocation concealment, we have not performed such an analysis, since none of the studies were assessed as being low risk of bias across all of the domains of bias we assessed.

Potential biases in the review process

There is a potential for bias to be introduced at any stage of the review process. In order to minimise the bias in the review process, two review authors independently screened studies for inclusion and any disagreements were resolved by a third review author. Data extraction and risk of bias assessment was performed by one reviewer and then checked by a second review author. Again any discrepancies were resolved by a third review author. It must be stressed that 'Risk of bias' assessment is subjective in nature and therefore another team of review authors may have graded studies differently. It is also worth noting that we did not formerly assess risk of bias in the 15 included cluster-randomized trials. Particular biases are unique to cluster designs, as described in the Handbook [section16.3.2] and formal assessments will be made of these in future updates. To minimise language bias any study not reported in English was translated into English and included in the review provided it met the inclusion criteria. This update was limited to primary outcomes so that it could be completed in time to inform important international guidance on infant feeding. All primary and secondary outcomes will be considered in the next update of this review. The development of a core outcome set for breastfeeding reviews is currently underway and this may influence the choice of outcomes in subsequent updates. This update, consistent with the previous versions of the review, combined different levels of interventions, so that trials in which breastfeeding mothers received the intervention were combined with trials where the intervention was directed at the staff providing the support. We will reconsider this approach in the next update. It is also of concern that there was missing data for 28 studies. Whilst we attempted to identify all the evidence on interventions to support breastfeeding (including published abstracts from conference proceedings) and followed-up ongoing studies, it is feasible that relevant research that is unpublished or not registered in a clinical trials register could have been missed.

Agreements and disagreements with other studies or reviews

The overall findings of this review, that breastfeeding support interventions have been shown to be effective in reducing the risk of cessation of any breastfeeding and of exclusive breastfeeding, are similar to the findings of other reviews (Rollins 2016; Sinha 2015). We concur with others, e.g. Hoddinott 2011 and Renfrew 2007, that it is critically important to identify the characteristics of support that may make this important but heterogenous intervention more or less effective in different circumstances and settings. For example, Jolly 2012b found that peer support had a greater effect on reducing the risk of non-exclusive breastfeeding in low- and middle-income countries compared to high-income countries, especially in the UK. Other recent reviews have found that interventions to increase breastfeeding duration and exclusivity are more effective when delivered as multi-component structured programmes such as the Baby Friendly Hosptial Initiative/Baby Friendly Initiative (BFHI/BFI), in a combination of settings (Beake 2012; Pérez-Escamilla 2016; Rollins 2016; Sinha 2015).

Authors' conclusions

Implications for practice

When breastfeeding support is offered to women, the duration and exclusivity of breastfeeding is increased. Characteristics of effective support include: that it is offered as standard by trained personnel during antenatal or postnatal care, that it includes ongoing scheduled visits so that women can predict when support will be available, and that it is tailored to the setting and the needs of the population group. Support is likely to be more effective in settings with high initiation rates. Support may be offered either by professional or lay/peer supporters, or a combination of both. Strategies that rely mainly on face-to-face support are more likely to succeed with women practising exclusive breastfeeding.

Implications for research

There is a very large number of trials in this field and this number continues to grow. This has resulted in a great deal of research time, energy and funding. While there are still questions to address about how best to provide support, the key messages are clear – we have ample evidence to know that women need support to be available and to be provided using the characteristics we have identified to increase the duration and exclusivity of breastfeeding. The key research question for the future is to identify how such support can best be provided consistently, for all women, in all countries. This becomes a scaling-up issue, which needs implementation and quality improvement approaches rather than effectiveness studies.

Any future studies should describe in detail the attributes of the intervention (who delivered it, setting, intensity, proactive or reactive); standard care (Baby Friendly accreditation or not, staff trained in breastfeeding or not); the population group studied (low- versus high-income, any selection criteria); and the background breastfeeding rates in the population studies. Studies should also examine the potential for synergy between support and other interventions that aim to increase breastfeeding rates, as it may be that a package of interventions is more effective than single interventions in tackling the multifaceted challenge of increasing breastfeeding rates. Packages to be tested could include peer and professional support along with, for example, antenatal education, staff training, and mother-to-mother support. Studies should also assess the effectiveness of lay, professional and combined support in different settings - in particular in those communities with low rates of breastfeeding initiation. Implementation of the Baby Friendly Initiative should be accompanied by the continued monitoring of breastfeeding rates to explore whether its effect is similar in countries with differing rates of initiation and prevalence of breastfeeding.

Further study is also required to:

  • test the effectiveness of different training programmes (which should be well-defined and reproducible) and should attempt to address impact on both exclusive and any breastfeeding where possible;

  • analyse and develop the theoretical basis for their approach, and analyse the elements of their approach that appear to have an impact, including training, timing, and intensity of the intervention, and differential impact on different population subgroups;

  • establish the cost-effectiveness of different interventions;

  • investigate appropriate strategies for supporting women who wish to breastfeed for longer than six months;

Acknowledgements

The review authors wish to thank those study authors who were very helpful in responding to queries.

As part of the prepublication editorial process, this review has been commented on by two peers (an editor and referee who is external to the editorial team), a member of the Pregnancy and Childbirth Group's international panel of consumers and the Group's Statistical Adviser.

Work on this review was supported in part by a grant from the National Institute for Health Research Health Technology Assessment programme, grant number 10/106/01.

This research was supported by a grant from the Evidence and Programme Guidance Unit, Department of Nutrition for Health and Development, World Health Organization. The findings, interpretations and conclusions expressed in this paper are entirely those of the authors and should not be attributed in any manner whatsoever to WHO.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Thanks to Hannah Soley for translating Lucchini 2013.

Data and analyses

Download statistical data

Comparison 1. All forms of support versus usual care
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping breastfeeding (any) before last study assessment up to 6 months5121418Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.95]
2 Stopping exclusive breastfeeding before last study assessment up to 6 months4618591Risk Ratio (M-H, Random, 95% CI)0.88 [0.85, 0.92]
3 Stopping breastfeeding (any) at up to 4-6 weeks3311264Risk Ratio (M-H, Random, 95% CI)0.87 [0.80, 0.95]
4 Stopping exclusive breastfeeding at up to 4-6 weeks3210960Risk Ratio (M-H, Random, 95% CI)0.79 [0.71, 0.89]
5 Sensitivity analysis by risk of bias allocation concealment: stopping any breastfeeding at up to six months51 Risk Ratio (M-H, Random, 95% CI)Subtotals only
5.1 Studies at low risk of bias2713465Risk Ratio (M-H, Random, 95% CI)0.93 [0.89, 0.96]
5.2 Unclear or high risk of bias247953Risk Ratio (M-H, Random, 95% CI)0.89 [0.83, 0.95]
6 Sensitivity analysis by risk of bias allocation concealment: stopping exclusive breastfeeding at up to six months46 Risk Ratio (M-H, Random, 95% CI)Subtotals only
6.1 Studies at low risk of bias2711351Risk Ratio (M-H, Random, 95% CI)0.93 [0.89, 0.96]
6.2 Unclear or high risk of bias196828Risk Ratio (M-H, Random, 95% CI)0.74 [0.65, 0.84]
7 Sensitivity analysis by risk of bias allocation concealment: stopping any breastfeeding at 4-6 weeks31 Risk Ratio (M-H, Random, 95% CI)Subtotals only
7.1 Studies at low risk of bias196817Risk Ratio (M-H, Random, 95% CI)0.88 [0.81, 0.96]
7.2 Unclear or high risk of bias123528Risk Ratio (M-H, Random, 95% CI)0.84 [0.68, 1.03]
8 Sensitivity analysis by risk of bias allocation concealment: stopping exclusive breastfeeding by 4-6 weeks32 Risk Ratio (M-H, Random, 95% CI)Subtotals only
8.1 Studies at low risk of bias207107Risk Ratio (M-H, Random, 95% CI)0.87 [0.79, 0.96]
8.2 Unclear or high risk of bias123164Risk Ratio (M-H, Random, 95% CI)0.64 [0.48, 0.86]
Analysis 1.1.

Analysis 1.1.

Comparison 1 All forms of support versus usual care, Outcome 1 Stopping breastfeeding (any) before last study assessment up to 6 months.

Analysis 1.2.

Analysis 1.2.

Comparison 1 All forms of support versus usual care, Outcome 2 Stopping exclusive breastfeeding before last study assessment up to 6 months.

Analysis 1.3.

Analysis 1.3.

Comparison 1 All forms of support versus usual care, Outcome 3 Stopping breastfeeding (any) at up to 4-6 weeks.

Analysis 1.4.

Analysis 1.4.

Comparison 1 All forms of support versus usual care, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Analysis 1.5.

Analysis 1.5.

Comparison 1 All forms of support versus usual care, Outcome 5 Sensitivity analysis by risk of bias allocation concealment: stopping any breastfeeding at up to six months.

Analysis 1.6.

Analysis 1.6.

Comparison 1 All forms of support versus usual care, Outcome 6 Sensitivity analysis by risk of bias allocation concealment: stopping exclusive breastfeeding at up to six months.

Analysis 1.7.

Analysis 1.7.

Comparison 1 All forms of support versus usual care, Outcome 7 Sensitivity analysis by risk of bias allocation concealment: stopping any breastfeeding at 4-6 weeks.

Analysis 1.8.

Analysis 1.8.

Comparison 1 All forms of support versus usual care, Outcome 8 Sensitivity analysis by risk of bias allocation concealment: stopping exclusive breastfeeding by 4-6 weeks.

Comparison 2. All forms of support versus usual care: SUBGROUP ANALYSIS - who delivered the intervention
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding before last study assessment up to 6 months5121418Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.95]
1.1 Professional support3716835Risk Ratio (M-H, Random, 95% CI)0.92 [0.89, 0.96]
1.2 Lay support93109Risk Ratio (M-H, Random, 95% CI)0.85 [0.77, 0.93]
1.3 Both professional and lay support51474Risk Ratio (M-H, Random, 95% CI)0.97 [0.91, 1.03]
2 Stopping exclusive breastfeeding before last study assessment4618424Risk Ratio (M-H, Random, 95% CI)0.88 [0.85, 0.92]
2.1 Professional support3012760Risk Ratio (M-H, Random, 95% CI)0.92 [0.89, 0.96]
2.2 Lay support134590Risk Ratio (M-H, Random, 95% CI)0.76 [0.65, 0.87]
2.3 Both professional and lay support31074Risk Ratio (M-H, Random, 95% CI)0.76 [0.44, 1.32]
3 Stopping any breastfeeding at up to 4-6 weeks3411815Risk Ratio (M-H, Random, 95% CI)0.84 [0.78, 0.92]
3.1 Professional support238104Risk Ratio (M-H, Random, 95% CI)0.81 [0.72, 0.91]
3.2 Lay support82789Risk Ratio (M-H, Random, 95% CI)0.91 [0.78, 1.06]
3.3 Both professional and lay support3922Risk Ratio (M-H, Random, 95% CI)0.87 [0.68, 1.11]
4 Stopping exclusive breastfeeding at up to 4-6 weeks3210934Risk Ratio (M-H, Random, 95% CI)0.79 [0.71, 0.89]
4.1 Professional support227435Risk Ratio (M-H, Random, 95% CI)0.84 [0.75, 0.95]
4.2 Lay support82354Risk Ratio (M-H, Random, 95% CI)0.64 [0.46, 0.89]
4.3 Both professional and lay support21145Risk Ratio (M-H, Random, 95% CI)0.94 [0.89, 0.99]
Analysis 2.1.

Analysis 2.1.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS - who delivered the intervention, Outcome 1 Stopping any breastfeeding before last study assessment up to 6 months.

Analysis 2.2.

Analysis 2.2.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS - who delivered the intervention, Outcome 2 Stopping exclusive breastfeeding before last study assessment.

Analysis 2.3.

Analysis 2.3.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS - who delivered the intervention, Outcome 3 Stopping any breastfeeding at up to 4-6 weeks.

Analysis 2.4.

Analysis 2.4.

Comparison 2 All forms of support versus usual care: SUBGROUP ANALYSIS - who delivered the intervention, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Comparison 3. All forms of support versus usual care: SUBGROUP ANALYSIS - type of support
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding before last study assessment up to 6 months5020946Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.95]
1.1 Predominantly telephone support3677Risk Ratio (M-H, Random, 95% CI)0.87 [0.65, 1.17]
1.2 Predominantly face-to-face contact2413890Risk Ratio (M-H, Random, 95% CI)0.90 [0.86, 0.95]
1.3 Balanced telephone and face-to-face support236379Risk Ratio (M-H, Random, 95% CI)0.92 [0.87, 0.98]
2 Stopping exclusive breastfeeding by last study assessment up to 6 months4619495Risk Ratio (M-H, Random, 95% CI)0.90 [0.87, 0.93]
2.1 Predominantly telephone support2419Risk Ratio (M-H, Random, 95% CI)1.0 [0.99, 1.01]
2.2 Predominantly face-to-face contact2913905Risk Ratio (M-H, Random, 95% CI)0.86 [0.81, 0.90]
2.3 Balanced telephone and face-to-face175171Risk Ratio (M-H, Random, 95% CI)0.97 [0.93, 1.00]
3 Stopping any breastfeeding by 4-6 weeks3211076Risk Ratio (M-H, Random, 95% CI)0.86 [0.79, 0.93]
3.1 Predominantly telephone support31133Risk Ratio (M-H, Random, 95% CI)0.76 [0.54, 1.08]
3.2 Predominantly face-to-face contact135186Risk Ratio (M-H, Random, 95% CI)0.84 [0.75, 0.94]
3.3 Balanced telephone and face-to-face174757Risk Ratio (M-H, Random, 95% CI)0.89 [0.78, 1.02]
4 Stopping exclusive breastfeeding by 4-6 weeks3110311Risk Ratio (M-H, Random, 95% CI)0.79 [0.69, 0.89]
4.1 Predominantly telephone support31142Risk Ratio (M-H, Random, 95% CI)0.92 [0.54, 1.55]
4.2 Predominantly face-to-face contact165382Risk Ratio (M-H, Random, 95% CI)0.68 [0.57, 0.81]
4.3 Balanced telephone and face-to-face133787Risk Ratio (M-H, Random, 95% CI)0.93 [0.88, 0.99]
Analysis 3.1.

Analysis 3.1.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS - type of support, Outcome 1 Stopping any breastfeeding before last study assessment up to 6 months.

Analysis 3.2.

Analysis 3.2.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS - type of support, Outcome 2 Stopping exclusive breastfeeding by last study assessment up to 6 months.

Analysis 3.3.

Analysis 3.3.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS - type of support, Outcome 3 Stopping any breastfeeding by 4-6 weeks.

Analysis 3.4.

Analysis 3.4.

Comparison 3 All forms of support versus usual care: SUBGROUP ANALYSIS - type of support, Outcome 4 Stopping exclusive breastfeeding by 4-6 weeks.

Comparison 4. All forms of support versus usual care: SUBGROUP ANALYSIS - timing of support
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding at last study assessment up to 6 months5121418Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.95]
1.1 Postnatal support alone3515570Risk Ratio (M-H, Random, 95% CI)0.91 [0.86, 0.95]
1.2 Antenatal component to support165848Risk Ratio (M-H, Random, 95% CI)0.92 [0.88, 0.97]
2 Stopping exclusive breastfeeding by last assessment up to 6 months4518374Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.94]
2.1 Postnatal support alone2911683Risk Ratio (M-H, Random, 95% CI)0.89 [0.84, 0.94]
2.2 Antenatal component to support176691Risk Ratio (M-H, Random, 95% CI)0.93 [0.89, 0.97]
3 Stopping any breastfeeding at 4-6 weeks3211262Risk Ratio (M-H, Random, 95% CI)0.86 [0.80, 0.93]
3.1 Postnatal support alone227793Risk Ratio (M-H, Random, 95% CI)0.83 [0.75, 0.93]
3.2 Antenatal component to support103469Risk Ratio (M-H, Random, 95% CI)0.90 [0.81, 1.00]
4 Stopping exclusive breastfeeding at up to 4-6 weeks3110311Risk Ratio (M-H, Random, 95% CI)0.79 [0.69, 0.89]
4.1 Postnatal support alone237764Risk Ratio (M-H, Random, 95% CI)0.75 [0.61, 0.93]
4.2 Antenatal component to support82547Risk Ratio (M-H, Random, 95% CI)0.89 [0.81, 0.96]
Analysis 4.1.

Analysis 4.1.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS - timing of support, Outcome 1 Stopping any breastfeeding at last study assessment up to 6 months.

Analysis 4.2.

Analysis 4.2.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS - timing of support, Outcome 2 Stopping exclusive breastfeeding by last assessment up to 6 months.

Analysis 4.3.

Analysis 4.3.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS - timing of support, Outcome 3 Stopping any breastfeeding at 4-6 weeks.

Analysis 4.4.

Analysis 4.4.

Comparison 4 All forms of support versus usual care: SUBGROUP ANALYSIS - timing of support, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Comparison 5. All forms of support versus usual care: SUBGROUP ANALYSIS - breastfeeding initiation
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding by last assessment up to 6 months4921162Risk Ratio (M-H, Random, 95% CI)0.92 [0.89, 0.95]
1.1 Settings with high breastfeeding initiation rates2111798Risk Ratio (M-H, Random, 95% CI)0.91 [0.86, 0.95]
1.2 Settings with Intermediate initiation rates187238Risk Ratio (M-H, Random, 95% CI)0.93 [0.89, 0.98]
1.3 Settings with low initiation rates102126Risk Ratio (M-H, Random, 95% CI)0.92 [0.84, 1.00]
2 Stopping exclusive breastfeeding at last assessment up to 6 months4116768Risk Ratio (M-H, Random, 95% CI)0.91 [0.87, 0.94]
2.1 Settings with high breastfeeding initiation rates2611347Risk Ratio (M-H, Random, 95% CI)0.84 [0.80, 0.90]
2.2 Settings with Intermediate initiation rates104052Risk Ratio (M-H, Random, 95% CI)0.97 [0.93, 1.02]
2.3 Settings with low initiation rates51369Risk Ratio (M-H, Random, 95% CI)1.00 [0.99, 1.01]
3 Stopping any breastfeeding at up to 4-6 weeks3112929Risk Ratio (M-H, Random, 95% CI)0.88 [0.82, 0.93]
3.1 Settings with high breastfeeding initiation rates115295Risk Ratio (M-H, Random, 95% CI)0.81 [0.71, 0.92]
3.2 Settings with Intermediate initiation rates176096Risk Ratio (M-H, Random, 95% CI)0.92 [0.85, 1.00]
3.3 Settings with low initiation rates61538Risk Ratio (M-H, Random, 95% CI)0.89 [0.79, 1.00]
4 Stopping exclusive breastfeeding at up to 4-6 weeks299911Risk Ratio (M-H, Random, 95% CI)0.78 [0.69, 0.89]
4.1 Settings with high breastfeeding initiation rates165933Risk Ratio (M-H, Random, 95% CI)0.72 [0.62, 0.84]
4.2 Settings with Intermediate initiation rates82609Risk Ratio (M-H, Random, 95% CI)0.87 [0.80, 0.95]
4.3 Settings with low initiation rates51369Risk Ratio (M-H, Random, 95% CI)0.97 [0.86, 1.08]
Analysis 5.1.

Analysis 5.1.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS - breastfeeding initiation, Outcome 1 Stopping any breastfeeding by last assessment up to 6 months.

Analysis 5.2.

Analysis 5.2.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS - breastfeeding initiation, Outcome 2 Stopping exclusive breastfeeding at last assessment up to 6 months.

Analysis 5.3.

Analysis 5.3.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS - breastfeeding initiation, Outcome 3 Stopping any breastfeeding at up to 4-6 weeks.

Analysis 5.4.

Analysis 5.4.

Comparison 5 All forms of support versus usual care: SUBGROUP ANALYSIS - breastfeeding initiation, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

Comparison 6. All forms of support versus usual care: SUBGROUP ANALYSIS - number of postnatal contacts
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Stopping any breastfeeding before last study assessment up to 6 months5121418Risk Ratio (M-H, Random, 95% CI)0.91 [0.88, 0.95]
1.1 Unspecified number of contacts107187Risk Ratio (M-H, Random, 95% CI)0.91 [0.85, 0.97]
1.2 Less than 4 postnatal contacts125151Risk Ratio (M-H, Random, 95% CI)0.93 [0.86, 1.00]
1.3 Between 4 and 8 postnatal contacts143236Risk Ratio (M-H, Random, 95% CI)0.86 [0.77, 0.97]
1.4 9 or more postnatal contacts155844Risk Ratio (M-H, Random, 95% CI)0.93 [0.88, 0.98]
2 Stopping exclusive breastfeeding before last study assessment4618424Risk Ratio (M-H, Random, 95% CI)0.88 [0.85, 0.92]
2.1 Unspecified number of contacts73645Risk Ratio (M-H, Random, 95% CI)0.92 [0.84, 1.02]
2.2 Less than 4 postnatal contacts114511Risk Ratio (M-H, Random, 95% CI)0.96 [0.91, 1.01]
2.3 Between 4 and 8 postnatal contacts165148Risk Ratio (M-H, Random, 95% CI)0.73 [0.63, 0.84]
2.4 9 or more postnatal contacts125120Risk Ratio (M-H, Random, 95% CI)0.89 [0.81, 0.98]
3 Stopping any breastfeeding at up to 4-6 weeks3311180Risk Ratio (M-H, Random, 95% CI)0.86 [0.79, 0.93]
3.1 Unspecified number of contacts62631Risk Ratio (M-H, Random, 95% CI)0.86 [0.75, 0.99]
3.2 Less than 4 postnatal contacts144789Risk Ratio (M-H, Random, 95% CI)0.83 [0.70, 0.99]
3.3 Between 4 and 8 postnatal contacts61088Risk Ratio (M-H, Random, 95% CI)0.79 [0.63, 1.00]
3.4 9 or more postnatal contacts82672Risk Ratio (M-H, Random, 95% CI)0.92 [0.80, 1.06]
4 Stopping exclusive breastfeeding at up to 4-6 weeks3210960Risk Ratio (M-H, Random, 95% CI)0.79 [0.71, 0.89]
4.1 Unspecified number of contacts51972Risk Ratio (M-H, Random, 95% CI)0.91 [0.84, 0.99]
4.2 Less than 4 postnatal contacts123768Risk Ratio (M-H, Random, 95% CI)0.90 [0.84, 0.96]
4.3 Between 4 and 8 postnatal contacts71519Risk Ratio (M-H, Random, 95% CI)0.63 [0.48, 0.82]
4.4 9 or more postnatal contacts93701Risk Ratio (M-H, Random, 95% CI)0.74 [0.40, 1.38]
Analysis 6.1.

Analysis 6.1.

Comparison 6 All forms of support versus usual care: SUBGROUP ANALYSIS - number of postnatal contacts, Outcome 1 Stopping any breastfeeding before last study assessment up to 6 months.

Analysis 6.2.

Analysis 6.2.

Comparison 6 All forms of support versus usual care: SUBGROUP ANALYSIS - number of postnatal contacts, Outcome 2 Stopping exclusive breastfeeding before last study assessment.

Analysis 6.3.

Analysis 6.3.

Comparison 6 All forms of support versus usual care: SUBGROUP ANALYSIS - number of postnatal contacts, Outcome 3 Stopping any breastfeeding at up to 4-6 weeks.

Analysis 6.4.

Analysis 6.4.

Comparison 6 All forms of support versus usual care: SUBGROUP ANALYSIS - number of postnatal contacts, Outcome 4 Stopping exclusive breastfeeding at up to 4-6 weeks.

What's new

DateEventDescription
29 February 2016New search has been performed

Search updated and 31 new studies included. The review now includes a total of 100 studies, with 73 studies providing data.

A 'Summary of findings' table has been incorporated in this update. In order to expedite this review rapidly to be ready to inform the World health Organisation recommendations on breastfeeding in maternity facilities, we have restricted the outcomes analysed in this update to the primary outcomes only. Secondary outcomes analysed in the previously published version of this review will be added in the next update of this review in two years time..

29 February 2016New citation required but conclusions have not changedConclusions broadly similar.

History

DateEventDescription
12 December 2011New search has been performedIn the previous version of this review (Britton 2007) we included 34 trials in 14 countries. In this updated version, we assessed 218 reports; corresponding to 150 separate studies. We have included 67 studies and excluded 79. Four studies are still ongoing or awaiting further assessment. In this updated version we have added further subgroup analysis and discuss the impact of different types of support interventions.
12 December 2011New citation required but conclusions have not changedThe update was prepared by a new author team. Studies were carried out in 21 countries. Overall conclusions have not changed, but we include more evidence on the effect of interventions in different settings and for different types of interventions; proactive interventions that rely mainly on face-to-face support are more likely to succeed.
27 July 2009AmendedSearch updated, 68 reports added to Studies awaiting classification.
6 November 2008AmendedConverted to new review format.
30 January 2006New citation required and conclusions have changed

New review team prepared this update.

Previous versions of this review categorised support as 'professional' or 'lay'. This edition introduces a new category: combined lay and professional support. Studies in this category demonstrated a significant effect on duration of any breastfeeding, especially in the first two months.

30 January 2006New search has been performedSearches updated. We have included fourteen new studies and excluded an additional 30 studies.

Contributions of authors

This update is based on the previous Cochrane Review, Renfrew 2012b, and has involved new authors.

Alison McFadden contributed to planning its restructure, assessment of study eligibility, data extraction and analysis and drafting text for the Background, Discussion and Conclusions, and commented on review drafts.

Anna Gavine contributed to planning its restructure, assessment of study eligibility, data extraction and analysis, drafting text for the Description of included studies, and commented on review drafts.

Mary Renfrew was co-author of earlier versions of this review and lead author of the previous version. In this update of the review she contributed to planning its restructure, and drafting text for the Background, Discussion and Conclusions, and commented on review drafts.

Angela Wade provided statistical advice for this and all the earlier versions of this review. She advised about including cluster-randomised trials in the analyses and commented on review drafts.

Phyll Buchanan contributed to assessment of study eligibility, data extraction, and commented on drafts.

Jane Taylor contributed to assessment of study eligibility, data extraction, and commented on drafts.

Emma Veitch contributed to assessment of study eligibility, data extraction, and commented on drafts.

Anne-Marie Rennie contributed to assessment of study eligibility, data extraction, and commented on drafts.

Susan Crowther contributed to assessment of study eligibility, data extraction, and commented on drafts.

Sara Neiman contributed to assessment of study eligibility, data extraction, and commented on drafts.

Steve MacGillivray co-ordinated this update and contributed to planning its restructure, assessment of study eligibility and data extraction. He set up conducted and reported the analyses, drafted text for the Methods and Results sections and commented on review drafts.

Declarations of interest

Alison McFadden: nothing to declare.

Anna Gavine: my institution (University of Dundee) has received two small grants from WHO to support my contribution to this review.

Mary Renfrew: my institution (University of Dundee) received two small grants from WHO to help with completion of this review. This paid for some research support for data extraction and analysis.

Angela Wade: nothing to declare.

Phyll Buchanan: I am a trustee of the Breastfeeding Network and therefore interested in the effectiveness of support for breastfeeding mothers, especially peer support.

Jane Taylor: I am a volunteer in the Breastfeeding Network and therefore interested in the effectiveness of support for breastfeeding mothers.

Emma Veitch: I am a volunteer in the Breastfeeding Network and therefore interested in the effectiveness of support for breastfeeding mothers.

Sara Neiman: I am a volunteer in the Breastfeeding Network and therefore interested in the effectiveness of support for breastfeeding mothers. I work for the NHS as a Registered Midwife and therefore the evidence base is very important to me in my work.

Anne-Marie Rennie: as a midwife I have an interest in support for breastfeeding mothers, and my role as Infant Feeding Co-ordinator is also interested in support for breastfeeding mothers.

Susan Crowther: nothing to declare.

Steve MacGillivray: my institution (University of Dundee) has received two small grants from WHO to support my contribution to this review.

Sources of support

Internal sources

  • University of York, UK.

External sources

  • Cochrane Pregnancy and Childbirth received a grant from the Evidence and Programme Guidance Unit, Department of Nutrition for Health and Development, World Health Organization, Switzerland.

  • National Institute for Health Research Health Technology Assessment programme, grant number 10/106/01, UK.

Differences between protocol and review

In the original protocol, (1998), Odds ratios (ORs) with 95% confidence intervals (CIs) were specified as being the measure of treatment effect. However, in the first published version of the review, Sikorski 1999, and in all subsequent versions of the review, Risk Ratios (RRs) with 95% CIs have been presented. In the original protocol, the subgroups specified for investigation of heterogeneity were reported as being income group and both ante- and post-natal time periods. Income group was removed from subsequent versions and with the addition of many more studies, the following subgroups have been incorporated:

  1. By type of supporter (professional versus lay person, or both).

  2. By type of support (face-to-face versus telephone support).

  3. By timing of support (antenatal and postnatal versus postnatal alone) - in original protocol.

  4. By whether the support was proactive (scheduled contacts) or reactive (women needed to request support).

  5. By background breastfeeding initiation rates (low, medium or high background rates).

  6. By intensity of support (number of scheduled contacts.

No sensitivity analyses were specified in the original protocol, 1998. In subsequent versions of the review and in the current update, sensitivity analyses looking at the effect of allocation concealment by comparing results from studies at low risk of bias as opposed to unclear or high risk of bias were incorporated.

The methods section has been updated to the current standard methods for Cochrane Pregnancy and Childbirth reviews and the review now focuses on healthy mothers with healthy term infants. A 'Summary of findings' table has been incorporated for this 2016 update.

In this update, 2016, we have not included data for the following secondary outcomes. Primary outcomes were recorded for stopping any or exclusive breastfeeding before four to six weeks and before six months postpartum. Other outcomes of interest in previous versions of this review were stopping any or exclusive breastfeeding at other time points (two, three, four, nine and 12 months), measures of neonatal and infant morbidity (where available) and measures of maternal satisfaction with care or feeding method. Secondary outcomes were not considered in this update so that the review could be completed in time to inform the World Health Organisation’s review of the evidence and update of the WHO recommendations on breastfeeding in maternity facilities. A new set of core outcomes for Cochrane pregnancy and childbirth breastfeeding reviews is currently being developed and the outcomes from this core set may influence future outcomes chosen for this review.

Secondary outcomes included in last update, 2012:

  1. Stopping breastfeeding before two, three, nine and 12 months postpartum.

  2. Stopping exclusive breastfeeding before two, three, nine and 12 months postpartum.

  3. Maternal satisfaction with care.

  4. Maternal satisfaction with feeding method.

  5. All-cause infant or neonatal morbidity.

In this update, 2016, "healthy" in terms of types of participants has been more clearly defined: "Participants were healthy pregnant women considering or intending to breastfeed or healthy women who were breastfeeding healthy babies.Healthy women and babies were considered those who did not require additional medical care (e.g. women with diabetes, women with HIV/AIDs, overweight or obese women) or surgical care (e.g. women who required a Caesarean Section). Studies which focused specifically on women with additional care needs were excluded."

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abbass-Dick 2015

Methods2-arm RCT, single-site, n = 214
Participants

Large urban teaching hospital in Toronto, Canada

Background rates of breastfeeding initiation: 89%

Inclusion criteria: primiparous mothers in the first 2 days postpartum, singleton birth, ≥ 18 years old, ≥ 37 weeks’ gestation at delivery, able to speak and read English, and living with a male partner

Exclusion criteria: women sharing a hospital room with a current study participant, a medical problem that could interfere with breastfeeding, infant not discharged from hospital with them, no access to the Internet or a telephone, planning to breastfeed for < 12 weeks, and had a partner who would not be available to participate in the study

Interventions

Intervention: the trial intervention was a multifaceted coparenting breastfeeding support intervention, provided face-to-face on the postpartum unit, at which time the couples were provided with breastfeeding information, the information package was reviewed, and couples were given the option of watching a video. The session took ∼15 min in the majority of cases. Couples had a take-home breastfeeding booklet, developed by Best Start: Ontarios Maternal, Newborn and Early Child Development Resource Centre,

access to a secure study web site that consisted of extensive information on breastfeeding and coparenting and contained links to related information and resources on the Internet including a copy of the video to watch at home. The couples were followed up at home with emails at 1 and 3 weeks postpartum and a telephone call at 2 weeks postpartum to answer any questions or concerns about the information provided.

Control: couples received usual care, which included standard in-hospital breastfeeding support and any breastfeeding assistance that was proactively sought in the community.

Outcomes

Primary:

Exclusive breastfeeding at 6 weeks and 12 weeks postpartum

Secondary:

Breastfeeding duration at 6 and 12 weeks postpartum

Maternal perceptions of breastfeeding support

Maternal perception of the coparenting relationship at 12 weeks postpartum

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskIntervention group by sequentially numbered randomly generated numbers
Allocation concealment (selection bias)Low riskSealed, opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskEnvelopes were constructed by a research assistant who was not involved in any other trial procedure. Participants not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskParticipants in intervention group were known to assessors because they were interviewed.
Incomplete outcome data (attrition bias)
All outcomes
Low riskMissing data were < 25%. Complete follow-up data were collected from 87.9% (n = 188) of fathers at 6 weeks and 88.3% (n = 189) of mothers at 6 weeks and 91.6% (n = 196) at 12 weeks.
Selective reporting (reporting bias)Low riskPrimary and secondary outcomes detailed in the study protocol were reported.
Other biasUnclear riskThere were no significant differences in baseline characteristics between the groups except prenatal education. However, there was a non-significant difference between the 2 groups in attendance at a prenatal breastfeeding class.

Aidam 2005

Methods3-arm RCT, with individual randomisation n=231
Participants

The study was carried out in the Tema area of Ghana (sub-Saharan Africa). Women were recruited in prenatal clinics in 2 hospitals (1 government and 1 private) that served urban areas (an industrial city and a commercial town).

High baseline prevalence of breastfeeding in Ghana, the median duration of breastfeeding was reported as being 22 months and 53.4% of women with babies < 6 months breastfeed exclusively. It was reported that "almost all" mothers initiated breastfeeding.

231 women randomized (136 eligible at the beginning of the intervention period).

Inclusion criteria: pregnant women in the last trimester planning delivery in the study hospitals and to stay in study area for 6 months after delivery. After delivery: singleton babies with normal birthweight (> 2500 g) and Apgar scores ≥ 6 at 1 min and 5 min

Exclusion criteria: multiple birth, low Apgar score or planning to move out of area

Participant characteristics:

38% of the women had only primary level or no formal education; 90% were married or living with a partner; 46% were primiparous; 73% had vaginal birth; 24% lived in households with access to a car; 74% were described as trader/artisan

Interventions

All 3 groups (intervention 1, intervention 2 and control) were allocated to 2 educational group sessions during pregnancy by trained nurses and 9 proactive home visits by trained nurse counsellors at 1, 2, 4, 6, 8, 12, 16, 20 and 24 weeks postpartum. These were in addition to standard care. The content of the sessions differed between the 3 groups. 63% of intervention 1, 73% of intervention 2 and 65% of the control group women received all 9 scheduled home follow-up visits.

Intervention 1 (n = 74): 43 followed up. Content of sessions was breastfeeding and exclusive breastfeeding. Trained local nurses with experience of breastfeeding gave 2 educational sessions, of approximately 20 min each, to groups of 2-4 women during their third trimester. At postpartum home visits women received individual counselling and nurses were advised to respond to concerns. Materials were developed from WHO/UNICEF breastfeeding counselling training manual.

Intervention 2 (n = 72): 44 followed up. Content of the pregnancy sessions was general health and childcare as for control group. Content of the postpartum home visits was breastfeeding and exclusive breastfeeding as for intervention 1.

Control (n = 85): 49 followed up. Content of sessions was general health and childcare topics such as immunisation, HIV/AIDS, nutrition and family planning.

OutcomesBreastfeeding status at 1, 2, 3, 4, 5, and 6 months, exclusive breastfeeding up to 6 months, infant morbidity and growth
NotesWe have not included data from this study in the review due to high levels of attrition (> 25% loss to follow-up). Most data were reported in graphs and difficult to interpret. Several measures of exclusive breastfeeding were reported; at 1 and 6 months women were asked about breastfeeding since birth, during previous month and on previous day. In this review we have reported figures for exclusive breastfeeding since birth for both time points. Figures in the paper were expressed as percentage of women still exclusively breastfeeding; in order to use the data we used subtraction to calculate a figure for women who had stopped breastfeeding.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: “Randomization was achieved by writing numbers 1 to 3 on folded pieces of paper."
Allocation concealment (selection bias)High risk

Quote: "The numbers were not viewed by either study staff or mothers and the pieces of paper looked the same on the outside. Before offering papers to mothers, they were shuffled in the interviewer’s palm.”

Quote: “The randomisation scheme used was not a formal one. It was one that could be conducted easily in the field. Despite this, it functionally produced balanced groups with no evidence of bias.” 

Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was stated that women were informed only that they would receive “health education” that would be beneficial to their infants and themselves, but were not aware of their group allocation or of differences in the content of the health education. However, it is not possible to blind.
Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "It was impossible to keep counsellors unaware of study design.... research assistants [collecting outcome data] were aware of mothers group allocation."
Incomplete outcome data (attrition bias)
All outcomes
High risk

231 women randomized during the third trimester. At delivery 95 women were excluded as they were no longer eligible (41% lost before the intervention). A further 13 women were lost to follow-up during the intervention period.  123 completed the final follow-up at 6 months (i.e. 53% of the original randomized sample but 90% of those still eligible at delivery).

Results were reported in graphs and percentages and it was not clear how many women commenced breastfeeding, so group denominators are not clear.

Loss to follow-up appeared balanced across groups.

Selective reporting (reporting bias)Unclear riskFailure to provide denominators for results means that they are very difficult to interpret.
Other biasUnclear riskWomen in the 3 arms of the trial appeared similar at baseline. Analysis was according to group allocation.

Aksu 2011

MethodsRCT, single site, a Baby-Friendly hospital, March-July 2008, n = 66
Participants

Urban state maternity hospital in Turkey

Background rates of breastfeeding initiation: high

Inclusion criteria: primaparous, live vaginal birth, healthy term singleton infant, living in study area, able to speak Turkish, no history of chronic diseases, non-smoker, intending to breastfeed

Exclusion criteria: infant birthweight < 2500 g, Apgar score ≤ 7, congenital anomalies, serious disease or needing intensive care

Baseline prevalence of "ever breastfed" in Turkey: 96.7% (WHO Global data bank 2010, accessed 6 October 2011).

Interventions

Intervention: women received standard breastfeeding support plus support from trained lay supporters who had undergone WHO/UNICEF 18-h training. The intervention was a single home visit on day 3 after the birth (in hospital), by 2 lay breastfeeding supporters, that lasted about 30 min and covered the same topics as routine support.

Control: at this Baby-Friendly hospital, a standard breastfeeding education session lasting 20-30 min was provided to all mothers before standard discharge home at 24 h after the birth. The session included the topics covered by the 18-h WHO/Unicef training.

OutcomesExclusive breastfeeding at 2 and 6 weeks and 6 months postpartum; breastfeeding duration (any/exclusive) to 18 months; breastfeeding knowledge scores at 2 and 6 weeks postpartum
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random numbers
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information provided to enable a judgement to be made
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskWomen were contacted either through home visits or via the phone and data on breastfeeding was collected, however, not reported whether the assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk82% follow-up at 18 months. Reasons for loss were explained and were balanced across groups.
Selective reporting (reporting bias)Low riskNot apparent
Other biasLow riskGroups appeared similar at baseline.

Albernaz 2003

MethodsPrimary care facilities, recruitment over 5 months, n = 169
Participants

3 hospitals in the city of Pelotas, in southern Brazil

Background rates of breastfeeding initiation: 88%

Ethnic composition not described.

Inclusion criteria: term healthy baby, family income ≥ USD 500 per month (no economic constraints to baby's growth), mother intended to breastfeed and did not smoke.

Exclusion criteria: multiple birth, gestational age not 37-42 weeks, significant perinatal morbidity, maternal smoking and family income USD 500 per month.

Interventions

Intervention: hospital visit, home visits at 5, 15, 30, 45, 90 and 120 days, and 24-h telephone hotline for help or to arrange visits. 2 members of the lactation support team had received the 40-h WHO lactation support training course.

Control: attended paediatric clinics where general advice on advantages of breastfeeding may have been offered, but specific lactation counselling was not provided.

OutcomesBreastfeeding pattern and duration up to age of 4 months. Breastmilk intake for a subgroup of 68 infants at 4 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated code
Allocation concealment (selection bias)Low riskSealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information provided to enable a judgement to be made
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe interviewers were not informed about the intervention or control status of each mother, and did not know the study's objectives.
Incomplete outcome data (attrition bias)
All outcomes
High risk188 women were randomized. 21 were excluded after 2 weeks as they had introduced formula milk. A further 26 withdrew (some data were available for some of these women). 141 women completed the trial (75%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskExcluding women who introduced formula within 2 weeks of randomisation is likely to have introduced bias although similar numbers were excluded from both groups (9 women lost from the intervention group for this reason and 11 women from the control group and an additional control was withdrawn for smoking).

Anderson 2005

Methods2-arm RCT, with individual randomisation N=135
Participants

Hartford area of Connecticut, USA in a hospital providing care for predominantly Latina low-income women

Inclusion criteria: age ≥18 years; gestational age < 32 weeks at first approach; healthy, considering breastfeeding, planning delivery at study hospital and resident in area for 3 months after the birth, 185% of the federal poverty level, available for telephone contact and willing to participate

Exclusion criteria for mothers: medical conditions such as diabetes or hypertension; drug use that could impair breastfeeding

Exlusion criteria for infants: preterm, low birthweight (< 2500 g), any complications requiring admission to special care, Apgar score < 7 at 1 min and 5 min

Participant characteristics: at baseline: intervention n = 63; control n = 72

Participant characteristics:

Married/cohabiting: intervention 40%; control 26%

Hispanic race: intervention 81%; control 64%

Education less than high school: intervention 31%; control 38%

Received welfare: intervention 31%; control 38%

Primiparous: intervention 92%; control 89%

Planned breastfeeding duration < 6 months: intervention 20%; control 46%

Planned breastfeeding duration 6-12 months or longer: intervention 80%; control 54%

Interventions

Intervention: in addition to standard care, women received 3 prenatal home visits, daily in-hospital visits and 9 postpartum home visits from peer counsellors: 3 in first week, 2 in second week and 1 in each week for weeks 3-6. Women could also phone peer counsellors. Peer counsellors were mothers from the area with experience of successful breastfeeding and training from a lactation consultant (LC).

Control: women received what would have been standard care for private patients (these women may not have normally qualified to receive this care as many were participating in welfare programmes). This consisted of: breastfeeding support line open to mothers after delivery staffed by a lactation specialist. Usual in-patient care and support for breastfeeding was provided by hospital staff.

OutcomesInfant feeding practices (weekly for first month) breastfeeding and exclusive breastfeeding. Infant morbidity (diarrhoea and ear infection). Breastfeeding outcomes measured in 3 different ways – over the past 24 h, over the past week and since the birth (ever given).
NotesWe have not included data from this study in the review due to high levels of attrition (> 25% loss to follow-up).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSPSS software was used to randomly assign subjects to study groups.
Allocation concealment (selection bias)Low risk

Quote: "Recruited subjects were entered into the database at the end of every week” and then random allocation by computer software.

 

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated if women or peer counsellors were blinded, but unlikely.
Blinding of outcome assessment (detection bias)
All outcomes
High riskNot a double-blind study and the interviewer knew the study hypotheses. Steps were taken to prevent interviewer bias by asking questions regarding peer counsellor contact at the very end of each follow-up interview session.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk182 women were recruited and randomized. 162 were still eligible at delivery and 135 completed the trial (84% of those still eligible at delivery and 74% of the total randomized).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups appeared similar at baseline although women in the control group were more likely (46%) to plan to breastfeed for < 6 months than women in the intervention group (20.4%). This difference in breastfeeding intentions means that the results are more difficult to interpret.

Barros 1994

Methods2-arm RCT, single-site, n = 900
Participants

Urban setting in Brazil: in-patient maternity unit

Background rates of breastfeeding initiation: high

Ethnic composition not described

Inclusion criteria: family income < twice the minimum Brazilian wage; hospital stay < 5 days; wanting to breastfeed: living within the city of Pelotas

Baseline prevalence in Pelotas (1993) for any breastfeeding: 85% at 1 month, 66% at 3 months and 38% at 6 months.

Interventions

Intervention: 3 home visits at 5, 10 and 20 days postpartum by a social assistant or nutritionist. The visitor was required to have a personal history of successfully breastfeeding a child and received training in breastfeeding physiology and common breastfeeding problems and their solutions.

Control: usual care, a social assistant would not normally make routine home visits but would visit only when requested to do so by the hospital team.

Outcomes

Breastfeeding at monthly intervals to 6 months and median duration of breastfeeding

Time to introduction of artificial feeds

Difficulties encountered during breastfeeding and reasons for weaning also recorded.

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskRecord in Portugese and no information in the translation regarding blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThe nurse collecting outcome data was not aware of previous contacts, but the authors stated that s/he may have been made aware of group assignment as women were likely to talk about the intervention.
Incomplete outcome data (attrition bias)
All outcomes
Low risk900 randomized, approximately 8% lost to follow-up in the intervention and control groups.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskNo baseline imbalance apparent. Assessment of risk of bias was made from translation notes. The original paper is in Portuguese.

Bashour 2008

Methods3-arm RCT, with individual randomisation N=903
Participants

Recruited from Maternity Teaching Hospital in Damascus, Syria

Background rates of breastfeeding initiation: high

Inclusion criteria: consenting women who delivered a healthy newborn by vaginal delivery or caesarean section, who lived within 30 km from hospital, and were available for follow-up for the next 6 months

Exclusion criteria for infants: premature, low birthweight (< 2500 g), with apparent congenital anomalies

Participant characteristics:

Age not clear.

Approximately 37% primiparous

90% had normal labour

> 99% of the women were married

Home conditions were described as bad (number of rooms, poor sanitation or water, etc.) in 28.5% of control group and approximately 20% of the intervention groups

Few of the women (approximately 5%) worked outside the home.

Interventions

Intervention 1 (n = 301): 4 structured home visits from trained midwives at 1, 3 and 7 days and 4 weeks after the birth. Midwives examined mothers and infants and provided and advice and support on a range of healthcare issues including breastfeeding support and education.

Intervention 2 (n = 301): a single postnatal visit from a trained midwife at 3 days which included advice and education on breastfeeding.

Control (n=301): received standard care in Syria (no postnatal visits).

Outcomes

Primary:

Maternal postpartum morbidities, postnatal care uptake, contraceptive uptake and type, infant morbidities, infant immunisation according to the national schedule at 3 months and Infant feeding (specifically exclusive breastfeeding during the first 4 months of life)

Secondary:

Women’s perceptions of their health, impressions about the home visit and perceptions of its quality

NotesSome baseline imbalance, women in the control groups were more likely to have poor home conditions and were less likely to have received antenatal care.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipants were randomized into blocks to either of the intervention groups (4 home visits or 1 home visit) or to the control group (no home visits). Randomisation was in blocks of 7 where a caseload of 21 eligible deliveries per day was assumed, based on the average daily number of deliveries in the hospital (ranging from 30 to 35) after excluding non-eligible cases.
Allocation concealment (selection bias)Low riskQuote: "Numbered, opaque and sealed envelopes..”  Group allocation was carried out by a senior midwife not involved in the rest of the study.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskThe midwives carrying out the intervention were not blinded. It was not stated whether the participants were blinded, but this is unlikely.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThe interviewers carrying out outcome assessment were not informed of groups, but would be aware of which group women were in from the interviews.
Incomplete outcome data (attrition bias)
All outcomes
Low risk903 women met the inclusion criteria. After randomisation (301 in each arm), 27 women were excluded (18 due to lack of address detail and 9 refusals). A total of 876 women were followed up in the 3 study groups: Intervention 1 (285 women), Intervention 2 (294 women) and Control (297 women). Incomplete data were addressed.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskSome baseline imbalance, women in the control groups were more likely to have poor home conditions and were less likely to have received antenatal care. Outcome data were collected at 4 months, but it is likely that there may have been recall bias for some outcomes, e.g. breast engorgement – women in the intervention groups would have discussed this and maybe it was recorded at the time it occurred, women in the control group would not have been asked until 4 months postpartum. Outcome data were collected for a large number of variables, so any differences may have occurred by chance.

Bhandari 2003

MethodsCluster-randomised study with 8 sites, n = 1115
Participants

8 village communities located 3 km-5 km from the main highway in Haryana, India

Background rates of breastfeeding initiation: high

Inclusion criteria: born in a study village within 9 months of start of intervention

Exclusion criteria: not reported

Baseline breastfeeding prevalence stated to be high

Interventions

Intervention: health and nutrition workers in the intervention communities received training based on Integrated Management of Childhood Illnesses Training Manual on Breastfeeding Counseling (WHO 1997). Messages - feed only breast milk for first 6 months of life; breastfeed the infant day and night, at least 8 times in 24 h; possible adverse effects of other foods and fluids given to breastfeeding infants - given to mothers at birth, plus monthly home visits, immunisation clinics and neighbourhood meetings.

Control: at the control sites, the research team provided routine services, in which, according to national policy, workers are required to advise exclusive breastfeeding for 4-6 months.

OutcomesFeeding at 3 months
Anthropometry and diarrhoea prevalence at 3 and 6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCommunities were paired on the basis of similar scores for socioeconomic, mortality and morbidity indicators. 1 of each pair was allocated to the intervention using a random number table. 8 areas were randomized (4 to each condition).
Allocation concealment (selection bias)Low riskStatistician independent of project carried out randomisation.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot stated whether participants and peer counsellors were blinded but unlikely.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAuthors state "we attempted to keep to a minimum reporting bias by use of a separate team for assessment of outcomes; this team did not take part in the intervention and was unaware of the hypothesis being tested".
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskReasons for drop-out recorded. 1151 births within the study period (not clear how many in each area). 588 families received the intervention and 527 no intervention. 895 completed 3 months follow-up (80%) and 880 6 months (79%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskAreas were paired, but it was not clear whether this achieved similar baseline characteristics between groups. Results were reported to have been adjusted for clustering.

Bloom 1982

Methods2-arm RCT, with individual randomisation (although the study also included a non-randomised comparison group)
Participants

100 breastfeeding mothers randomized; recruited 3 days after the birth

Inclusion criteria: married, primiparous with healthy infants born at a maternity hospital in Nova Scotia, Canada

Exclusion criteria: infants with birthweight < 2500 g, with Apgar scores < 5, twins, women having operative deliveries, women who did not speak English

Interventions

Women in both groups received a pamphlet on breastfeeding.

Intervention: weekly telephone calls beginning 10 days after the birth made by a nurse interviewer, offering support and advice and referral if necessary. Calls lasted 5-10 min and were described as friendly. Women received up to 3 calls up to 6 weeks postpartum. Calls ceased when women discontinued breastfeeding.

Control: women received usual care (not specified)

OutcomesInterviews at 6 weeks postpartum. Women were asked about infant behaviour and infant feeding and breastfeeding duration.
NotesWe have not included data from this study, because results in this paper were not reported in a form in which we could use them in the review. Most of the results were not reported according to randomisation group (rather authors described factors and associations with, e.g. breastfeeding). Breastfeeding in the randomized groups at 6 weeks was not reported and it was not possible to contact the authors to obtain this information. It was stated that average breastfeeding duration was 28.6 days in the intervention group vs 21.0 days for controls, but no SDs were reported. It was not clear when or how breastfeeding duration data were collected; if at the 6-week postpartum interviews this suggests that figures for average breastfeeding duration only apply to those women who had discontinued breastfeeding and denominators are therefore not clear.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskDescribed as “randomly assigned”.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskThe interviewer who recruited women also carried out the intervention.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe interviewer carrying out outcome assessment was reported not to be aware of the initial feeding choice (but may have been made aware of the intervention allocation by women).
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskRates of follow-up at 6 weeks were high (97%). However, denominators for breastfeeding duration results were not reported.
Selective reporting (reporting bias)Unclear riskMost results were not reported by randomisation group and are difficult to interpret.
Other biasUnclear riskUnclear - no baseline characteristics table for randomized groups.

Bonuck 2005

Methods2-arm RCT, n = 382
Participants

From 2 prenatal care centres in the Bronx, New York (reported to be the county in the USA with the highest poverty rate)

Background rates of breastfeeding initiation: low

Inclusion criteria: able to speak English or Spanish, singleton or twin pregnancy < 24 weeks (twins subsequently excluded), intending to keep infant and attend for prenatal and postnatal care at centre and affiliated hospital, telephone contact numbers available

Exclusion criteria: HIV-positive status, chronic disease with medication not compatible with breastfeeding, diabetes, serious illness, or breast reduction surgery

Participant characteristics:

57% Hispanic, 36% African-American, 62% multiparous (70% of these had previous breastfeeding experience), mean age 25 years (SD 6.23), 51.5% married or living with a partner, 57% receiving Medicaid

Interventions

Intervention (n = 188): delivered by a trained LC. Women were recruited when < 24 weeks pregnant, and had 2 prenatal LC visits scheduled. During late pregnancy there was telephone contact, and hospital and home visits and telephone support (up to 12 months postpartum) were planned for the postnatal period. In the postnatal period 25% of the intervention group received at least 1 hospital contact; approximately 50% had telephone and/or home visits; but 36% received no home or hospital visits and no telephone support.

Control (n = 194): women had no contact with the LC. Standard care varied between the sites and neither site followed an established protocol for breastfeeding. Women enrolled in women and child nutrition programmes (WIC) had the opportunity to visit a breastfeeding co-ordinator.

Outcomes

Infant health outcomes:

Duration of breastfeeding and exclusive breastfeeding was presented mostly in graphical form and was difficult to interpret. Breastfeeding was categorised on a 7-point scale from 7 = exclusive breastfeeding (which was defined as no other milk or food, but infants may have received water and other liquids) through to exclusive formula, between these extremes of the scale there were various 'intensities' of breastfeeding (e.g. > 50% breast milk). This meant that results were complicated and not easy to interpret. Women were followed up for up to 12 months and detailed (graphical) weekly data were reported for weeks 1-26 postpartum.

NotesResults estimated from graphs.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: “The project’s biostatistical office generated and maintained a list of random codes for subjects... undisclosed blocking factor and stratification according to center.”
Allocation concealment (selection bias)Low riskSealed envelopes, numbered and opened sequentially.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskIt was not stated whether the women were blinded. The LC providing the intervention was not blinded with respect to treatment group.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThe research assistant collecting breastfeeding outcome data was not blinded with respect to treatment group.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskWomen were recruited in the antenatal period. 382 women were randomized.  Loss to follow-up included 10 women who miscarried or terminated the pregnancy. 304 women were followed up into the postnatal period (80% of those randomized).  There were further missing data for longer term follow-up. Loss to follow-up was balanced across groups.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThe intervention did not appear to be standardised and many women in the intervention group (36%) did not receive any postnatal visits.

Bonuck 2014a

MethodsParallel 2-arm participant-level RCT, n = 666
Participants

Women who attended an urban medical centre providing prenatal care to a low income population in the Bronx, New York City.

Background rates of breastfeeding initiation:79%

Inclusion criteria: English- or Spanish-speaking women aged ≥18 years, in the first or second trimester of a singleton pregnancy

Exclusion criteria: risk factors for premature birth maternal or infant conditions that would preclude or complicate breastfeeding (e.g. mother HIV-positive, infant congenital anomaly)

Interventions

666 women were randomized in a 1:3:3:1 ratio to: usual care, electronic prompt (EP) alone, Lactation Consultant (LC) + EP, or LC alone. Only the LC and EP+LC arms are included in this review as the EP arm (n=253) was antental only and therefore does meet the review inclusion criteria for a breastfeeding support intervention.

LC intervention (n= 80): Two LCs were allocated to this intervention.The LC protocol included 2 prenatal sessions, a hospital visit, and regular phone calls postpartum for 3 months or until breastfeeding ceased. The prenatal sessions occurred in the examination room, during the 30-plus min of 'downtime' while waiting for the prenatal care provider. Attempts were made to complete interrupted sessions after the examination. The first session focused on rapport building and education, and the second was on the practical aspects of breastfeeding. The study provided nursing bras and breast pumps to LC group participants as needed. LCs met mothers and their infants at the 1-week routine paediatric visit, modelling practice on a recent review. Postpartum home visits were optional, based upon participant and LC preference and comfort.

LC + EP intervention (n=253): Included the LC protocol detailed above and electronic prompts for healthcare providers to ask three brief open-ended questions which portrayed breastfeeding as the norm. This was done during pre-natal care appointments.

Control (n=80): usual care

Outcomes

For BINGO, the prespecified primary outcome measure was 3-month breastfeeding intensity.

Quote: "We categorized breastfeeding intensity as < 20% (low), 20% to 80% (medium), and greater than 80% (high) of all feeds from breast milk consistent with previous studies and Infant Feeding Practices Survey II analyses.

Other analysis was planned. Power calculations were affected by the finding - “we found that breastfeeding intensity was not normally distributed, and most women stopped breastfeeding altogether during follow-up".
Other outcomes:

Quote: “Study staff assessed infant feeding at 1, 3, and 6 months postpartum during phone interviews using items adapted from the Infant Feeding Practices Survey II”; exclusive breastfeeding, breastfeeding intensity (“defined as the percentage of all feedings in the past 7 days that were breast milk”), breastfeeding initiation, and total duration data collected.

NotesThe paper reported 2 trials that appear in this review (PAIRINGS and BINGO).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Quote: "Women were randomized using sequentially numbered opaque sealed envelopes, generated by the study’s biostatistician".

Quote: "Randomization incorporated an undisclosed blocking factor and nativity status (US-born vs foreign-born)."

Allocation concealment (selection bias)Low riskSequentially numbered opaque sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "It was infeasible to blind participants and clinical staff to treatment group."
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "we sought to minimize bias by restricting access to allocation assignment, stripping group assignment from study databases to which research staff had access, and omitting group identifiers from participant interview form."
Incomplete outcome data (attrition bias)
All outcomes
Low riskThe BINGO analytic sample included 94% of those randomized (628 of 666 participants).
Selective reporting (reporting bias)Low riskWe checked the Clinicaltrials.gov record and the key breastfeeding outcome data seemed to be reported in this paper.
Other biasLow risk 

Bonuck 2014b

MethodsParallel 2-arm, participant-level RCT, (n=275)
Participants

Women who attended an urban medical centre providing prenatal care for a economically diverse population in the Bronx, New York City.

Background rates of breastfeeding initiation:79%

Inclusion criteria: English- or Spanish-speaking women aged ≥18 years, in the first or second trimester of a singleton pregnancy

Exclusion criteria: risk factors for premature birth maternal or infant conditions that would preclude or complicate breastfeeding (e.g. mother HIV-positive, infant congenital anomaly)

Interventions

Intervention (n=136): lactation counselling and electronic pumps. One LC was allocated to this intervention.The LC protocol included 2 prenatal sessions, a hospital visit, and regular phone calls postpartum for 3 months or until breastfeeding ceased. The prenatal sessions occurred in the examination room, during the 30-plus min of 'downtime' while waiting for the prenatal care provider. Attempts were made to complete interrupted sessions after the examination. The first session focused on rapport building and education, and the second was on the practical aspects of breastfeeding. The study provided nursing bras and breast pumps to LC group participants as needed. LCs met mothers and their infants at the 1-week routine paediatric visit, modelling practice on a recent review. Postpartum home visits were optional, based upon participant and LC preference and comfort. electronic prompts for healthcare providers to ask three brief open-ended questions which portrayed breastfeeding as the norm. This was done during pre-natal care appointments.

Control (n=139): usual practice.

Outcomes

For PAIRINGS, the prespecified primary outcome was exclusive breastfeeding at 3 months.

Other outcomes:

Quote: “Study staff assessed infant feeding at 1, 3, and 6 months postpartum during phone interviews using items adapted from the Infant Feeding Practices Survey II”; exclusive breastfeeding, breastfeeding intensity (“defined as the percentage of all feedings in the past 7 days that were breast milk”), breastfeeding initiation, and total duration data collected.

NotesThe paper reported 2 trials that appear in this review (PAIRINGS and BINGO).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipants were randomized using sequentially numbered opaque sealed envelopes, generated by the study’s biostatistician.
Allocation concealment (selection bias)Low riskSequentially numbered opaque sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "It was infeasible to blind participants and clinical staff to treatment group."
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "we sought to minimize bias by restricting access to allocation assignment, stripping group assignment from study databases to which research staff had access, and omitting group identifiers from participant interview form."
Incomplete outcome data (attrition bias)
All outcomes
Low riskAnalytic sample included 95% of those randomized (262 of 275 participants.
Selective reporting (reporting bias)Unclear riskBreastfeeding outcomes reported in Clinicaltrials.gov were reported in this paper. Other outcomes on weight and length were not reported in this paper, but they are not included as outcomes in this systematic review.
Other biasLow risk 

Bortolini 2012

Methods2-arm RCT, 1 site setting, n = 397 (unclear if this was the total number in the study overall)
Participants

Children recruited at birth at the Hospital Centenário (the only hospital in the city of São Leopoldo, state of Rio Grande do Sul, Brazil), only children in Brazilian National Health Service (Sistema Único de Saúde, SUS) wards were enrolled, between October 2001-June 2002.

Background rates of breastfeeding initiation: 95.8%

Inclusion criteria: newborn infants with birthweight ≥ 2500 g and gestational age ≥ 37 weeks

Exclusion criteria: none noted

Interventions

Intervention: mothers provided with dietary counselling based on the guidance provided in the Ten Steps for Healthy Feeding of Children Younger Than Two Years.

Counseling took place through 10 home visits: one in the first 10 days after birth, monthly up to 6 months and then at 8, 10 and 12 months. The dietary recommendations that the mothers were given prioritised exclusive breastfeeding up to 6 months and introduction of complementary foods at the age of 6 months. Mothers were advised not to give their children bottles or pacifiers. 12 undergraduate students of nutrition conducted the home visits in pairs. The entire team was trained in the dietary guidelines and in techniques for counselling mothers about the Ten Steps for Healthy Feeding of Children Younger Than Two Years. Each dietary counselling session lasted 30 min-40 min.

Control: women were visited at 6 and 12 months for collection of anthropometric, dietary and sociodemographic data and to collect data on the infants’ health status.

Interviewers, who were not involved in the intervention process and who were blinded to the group to which the children belonged, conducted home visits at 6 and 12 months in order to collect data on the study variables. Interviewers informed mothers about the anthropometric results and instructed them to attend the nearest health service if nutritional problems were detected.

OutcomesFollowing outcomes at 6 months of age for both groups: proportion of children exclusively breastfed for < 1 month; proportion of children exclusively breastfed for 4 months or more; proportion of children exclusively breastfed at 6 months; proportion of children recieving breastmilk at 6-12 months and age at introduction of cows milk.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskReported in another paper (Vitolo 2005) which is in Spanish and needs to be translated.
Allocation concealment (selection bias)Unclear riskReported in another paperVitolo 2005 which is in Spanish and needs to be translated.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskIt is not stated whether the women and undergraduate students providing the intervention were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskInterviewers who were not involved in the intervention process and were blind to the group to which the children belonged conducted home visits at 6 and 12 months in order to collect data on the study variables.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnable to assess with the information given.
Selective reporting (reporting bias)Unclear riskOutcomes not prespecified in clinicaltrials.gov record.
Other biasUnclear riskNone noted.

Brent 1995

Methods2-arm RCT with individual randomisation, single-site, duration not stated, n = 115
Participants

Urban USA - ambulatory care centre and in-patient maternity unit

Background rates of breastfeeding initiation: low

Baseline prevalence of breastfeeding at birth in national WIC sample = 33% (1991)

Inclusion criteria: English-speaking; nulliparous

Exclusion criteria: separated from child at birth; preterm delivery; child in NICU > 72 h

Ethnic composition: described as 71% white

90% of participants were eligible for WIC programmes for those on low income.

Study population not limited to those intending to breastfeed.

Interventions

Intervention: package of: 2-4 prenatal sessions with LC (10 min-15 min each); telephone call 48 h after discharge; visit to lactation clinic at 1 week postpartum (staffed by paediatrician or LC); contact with LC at each health supervision visit until weaning or 1 year; professional education of nursing and medical staff.

Control: women were offered optional prenatal breastfeeding classes, postpartum breastfeeding instruction by nurses and physicians and outpatient follow-up by nurses and physicians in the paediatric ambulatory department.

OutcomesRates of breastfeeding at 2 months and median duration of breastfeeding
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskSample stratified by age with block randomisation in blocks of 8.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and LC were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome data were collected by questionnaire administered by the LC who was not blinded to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskFollow-up 94%. It appeared that 115 women were randomized. It was stated that 7 in  the intervention group were excluded as they did not receive the intervention. 8 women in the control group were subsequently excluded from the analysis for at least some outcomes as the treatment they received deviated from protocol.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskPotential confounders: women were excluded from intervention group following randomisation if they had received fewer than 2 prenatal lactation consultations; ITT analysis not performed (8 women in control group who met LC excluded); intervention included input by staff caring for both intervention and control groups.

Bunik 2010

Methods2-arm RCT, with individual randomisation, with add-on qualitative study, n = 339
Participants

Denver, USA; a clinic providing care for a predominantly Hispanic, medically underserved population

Background rates of breastfeeding initiation: low

Inclusion criteria: women ≥ 18 years, primiparous with healthy, term, singleton baby who were willing to consider breastfeeding

Exclusion criteria: primary language not English or Spanish, medical complication that interfered with breastfeeding, hospital stay > 72 h following vaginal births or > 96 h following caesarean section, baby with medical problems, admitted to NICU or had a hospital stay > 72 h

Participant characteristics:

Mean age 22 years; 88% Hispanic or Latino; 77% vaginal delivery

Planned to breastfeed only: intervention group 50%, control group 55% (other women planned to combine breastfeeding with formula)

> 60% were participating in WIC programmes at 1 month and 74% of these women were provided with formula at WIC clinics.

Interventions

Intervention: daily telephone support, from the day following hospital discharge until 2 weeks postpartum, from trained nurses following a specific protocol covering advantages and disadvantages of breastfeeding, cultural issues, technique, problems and with referral for any lactation or medical problems.

Control: usual hospital care (pamphlets on breastfeeding, a breast pump, lanolin cream and a water bottle); usual discharge care (commercial discharge packs) and scheduled healthcare visits at 3-5 days and at 2 weeks at the local community health centre.

Outcomes

Any breastfeeding or predominantly breastfeeding

Maternal satisfaction

Healthcare utilisation

Reasons for stopping breastfeeding

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated block random allocation
Allocation concealment (selection bias)Low riskSequentially numbered opaque sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding for participants or caregivers.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding not described for outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk341 women were randomized. At 1 month there was approximately 8% loss to follow-up, By 6 months 27% loss. 73% were described as included in the analyses; women in the intervention group that did not receive the intervention as planned were not included.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups appeared similar at baseline.

Caldeira 2008

MethodsStudy methods were not clear. This appeared to be a cluster-randomised trial in 35 clinics. The intervention was carried out with healthcare workers. Results were for women attending intervention and control clinics before and after the intervention period.
Participants

Setting: family healthcare teams from Montes Claros city in South East Brazil

Baseline prevalence of breastfeeding initiation in country/setting: not clear

1423 women recruited (unclear). Follow-up for 12 months

Inclusion criteria: mothers with children between 0 and 2 years old registered with the family health teams

Participant characteristics:

Approximately 20% under 20 years, 38% primiparous, 27% vaginal deliveries, 90% with > 4 years' education

Interventions

Intervention: 20 healthcare teams received staff training to promote breastfeeding, based on the Baby Friendly Hospital Initiative. Duration of the intervention was unclear; there was an initial interview before the study and a second interview 12 months after the start of training. 

Control: healthcare teams (n = 15 - unclear) in control clinics did not receive the training.

OutcomesNumber of exclusive breastfeeding days; survival curves
NotesWe have not included data from this study. Data were not reported in a way in which we could incorporate results into the review. Authors reported the number of days, not the number of participants, for exclusive breastfeeding. It is reported that the median duration of exclusive breastfeeding was 106 days before and 107 days after the intervention period for the control group. For the intervention group the median duration of exclusive breastfeeding was reported to be104 days before and 125 days after the intervention period; the difference was reported to be statistically significant.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskMethod not described; it was reported that half of the women were assigned to the Intervention group and the other half to the control group.
Allocation concealment (selection bias)Unclear riskNot described; 20 intervention clinics and 15 control (not clear).
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot described in translation form.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot described in translation form.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot clear. Authors reported that dropouts were negligible because all children registered were contacted with the help of community health agent.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskData extraction from translation (original paper in Portuguese). Cluster trial with no apparent adjustment for design effect.

Cameron 2013

Methods4-arm RCT, 1 study site, n = 802
Participants

Maternity hospital in Dunedin, New Zealand

Background rates of breastfeeding initiation: not specified.

Inclusion criteria: all mothers who had booked into the single maternity hospital (> 97% of all births) serving the city of Dunedin, New Zealand, between May 2009-November 2010, as well as mothers who planned to give birth at home and were invited to participate by their midwife. Mothers were invited to participate at 28-30 weeks gestation and an 'opt out' recruitment strategy (eligible participants were contacted and excluded only when they said they were unwilling to participate) was used.

Exclusion criteria before birth: home address outside the greater Dunedin area, planning to move away from Dunedin in the next 2 years, booked into the maternity centre after 34-week gestation, or unable to communicate in English or Te Reo Maori [language of the indigenous (Maori) ethnic group of New Zealand].

Exclusion criteria after birth: identification of a congenital abnormality that was likely to affect feeding or growth, or the infant being born before 36.5 weeks gestation. When a mother delivered twins, the oldest child was recruited into the study. There were no triplets born during the study recruitment period.

Interventions

Interventions: various types of support:

1) infant sleep education only intervention (sleep);

2) Food, physical activity and breastfeeding (FAB) intervention: LC providing food, activity and breastfeeding help intervention;

3) combination of both 1 and 2 (Combo), participants received both the sleep and FAB interventions.

Total number randomized: n = 802 (sleep 192, FAB 205, Combo 196)

Control: usual care n = 209

Outcomes

Outcomes: delayed introduction of complementary foods at 5 months and preferably until 6 months

Complementary foods were defined as foods other than breast milk or infant formula (p 1483)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskUsed a computerised random-number generator, which assigned blocks of participants to the 4 arms.
Allocation concealment (selection bias)Low riskAllocation was concealed and performed after application of the prebirth exclusion criteria, stratified by socioeconomic status with use of the New Zealand Deprivation Index 2006.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskGroup allocation was revealed to the participant after consent to participate had been obtained.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskMost of the breastfeeding and other data were collected by a researcher who was not aware of the participants' group, and no data were collected by the LC who delivered the intervention. The statistician remained blinded to group allocation codes until primary analyses were conducted.
Incomplete outcome data (attrition bias)
All outcomes
Low risk< 25% attrition
Selective reporting (reporting bias)Unclear risk This study is a sub-sample of results from a larger study and the outcomes reported in the trial registration document are not reported in this study, However, the full study results have not yet been published to be able to judge this outcome.
Other biasLow riskAppears to be free of demographic variables, looks comparable across the groups.

Chapman 2004

Methods2-arm RCT, with individual randomisation; recruitment July 2000-August 2002 at an urban USA hospital with BFI accreditation, n = 219
Participants

Urban USA hospital prenatal clinic serving a low-income, predominantly Latina population

Background rates of breastfeeding initiation: low

Antenatal inclusion criteria: low-income women ≥ 18 years old, at ≤ 26 weeks' gestation, considering breastfeeding, not yet enrolled in peer counselling programme, resident in hospital area, available for telephone follow-up

Postnatal inclusion criteria: healthy, full term singleton infants, no congenital abnormalities, no maternal history of HIV and no admission to NICU

Exclusion criteria: none specified

After birth, n = 165 women remained in the study, 90 in the intervention group and 75 controls.

Participant characteristics: ethnic composition 80% Hispanic (61% Puerto Rican origin), 9% African American, 3% white, 8% other

Interventions

Intervention: 1 prenatal home visit, daily visits during postpartum hospitalisation, home visit within 24 h and at least 2 more home visits as requested, and telephone/pager contact. Intervention from peer counsellors with 30 h classroom training that covered La Leche League International Peer Counseling Program and Hispanic Health Council's curricula. Peer counsellors had to score 85% in a written exam and work for 3-6 months with experienced peer counsellors to demonstrate competence before working independently with clients. Peer counsellors had 1 h per month continuing education and were paid for their work.

Control: routine breastfeeding education offered by the study hospital, and the same breastfeeding services as women paying privately. A small amount of exposure to peer counsellors among the control group was reported.

OutcomesBreastfeeding rates at birth and 1, 3 and 6 months postpartum
Subgroups most responsive to breastfeeding peer counselling
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBy computer programme
Allocation concealment (selection bias)Unclear riskNot described.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo detail provided about whether participants and personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was not stated whether outcome assessors were blinded, but to minimise bias, data related to peer counsellor contact were collected at the end of each interview.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLoss to follow-up appeared reasonably balanced although there was more loss from the control group. Reasons for loss to follow-up stated. 219 were randomized, 72% followed up at 1 month, 70% at 3 months and 66% at 6 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskGroups appeared similar at baseline. It was reported that many women in the intervention group received less than half of the planned visits.

Chapman 2008

Methods2-arm RCT , 1 site, n = 206
Participants

Hartford Hospital prenatal clinic. Hospital with BFI status, the prenatal clinic serves a low-income, predominantly Latina population. Study population (82% Latina, with Puerto Ricans comprising 50% of Latinas)

Background rates of breastfeeding initiation: not specified

Inclusion criteria at prenatal recruitment: be considering breastfeeding and have a prepregnancy BMI ≥ 27, ≥ 18 years of age, ≤ 36 weeks' gestation, singleton pregnancy, absence of medical conditions that would interfere with breastfeeding, planning to remain in the area for 6 months postpartum, income < 185% of the federal poverty level, and have telephone access

Inclusion criteria at delivery: ≥ 36 weeks' gestation, birthweight ≥ 2.5 kg and ≤ 3.9 kg, 1 min and 5 min Apgar scores of ≥ 6, and no NICU admission

Exclusion criteria: none stated

Interventions

Intervention: specialised breastfeeding peer counsellor (SBFPC) made 3 prenatal visits, plus daily in-hospital support, and up to 11 postpartum home visits promoting exclusive breastfeeding and addressing potential obesity-related breastfeeding barriers. Prenatal visits involved assessment of previous breastfeeding experiences/knowledge, personalised education about breastfeeding logistics, the risks of formula feeding, and anticipatory guidance. During hospitalisation, women received 1 SBFPC visit per day, which were similar in content to those provided by 'Breastfeeding: Heritage and Pride' (BHP) peer counsellors. The SBFPC ensured that intervention participants received a manual breast pump before discharge.

Control: standard breastfeeding support and staff peer counsellors (see below), which involved routine access to breastfeeding support from hospital personnel, including staff peer counsellors, plus prenatal breastfeeding education that included brief breastfeeding discussions during routine clinic appointments and receipt of written educational materials. Staff nurses provided routine perinatal breastfeeding assistance, with LCs available as needed. After discharge, participants could call the hospital telephone hotline with breastfeeding questions.

Standard care also included optional breastfeeding support from Breastfeeding: Heritage and Pride (BHP) peer counsellors (PC), who provided the following: up to 3 prenatal visits (covering breastfeeding benefits, breastfeeding myths, positioning, and common breastfeeding problems and to educate with up to 7 personalised home visits during the first year postpartum; and telephone support. If available, electric breast pumps were loaned as needed. To receive prenatal PC visits, controls could self-refer or be referred to the BHP program.

Outcomes

Primary: breastfeeding initiation and the rates of exclusive and any breastfeeding at 2 weeks, 1 month, 3 months, and 6 months postpartum

Secondary: infant morbidity (diarrhoea, otitis media, emergency department visits, hospitalisation), maternal amenorrhoea, and breastfeeding intensity

NotesHigh attrition due to randomisation prior to birth resulting in high exclusion (Intervention n = 76, 26.2%; Control n = 78, 24.3%) with further study attrition at 6 months (intervention n = 55; control n = 53 (> 25% attrition for various stated reasons)).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskAll participants provided written informed consent. Each week, the study co-ordinator used SPSS software (SPSS Inc, Chicago, IL) to randomly assign 50% of newly recruited participants to the intervention group, thus preserving allocation concealment.
Allocation concealment (selection bias)Unclear riskEach week, the study co-ordinator used SPSS software (SPSSInc, Chicago, IL) to randomly assign 50% of newly recruited participants to the intervention group, thus preserving allocation concealment (not sure how they did this using SPSS).
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThe interviewer was not informed of participants' group assignment, but was not completely blinded because she collected participant contact data. To minimise potential bias, participant contact questions were asked at the end of each interview.
Incomplete outcome data (attrition bias)
All outcomes
High riskAll attrition > 25%
Selective reporting (reporting bias)Unclear riskThe paper contains additional outcomes that were not included in the clinicaltrials.gov record.
Other biasHigh riskThe intervention group was significantly younger and differed in delivery mode, compared with the control group.

Chen 1993

Methods3-arm quasi-RCT, with sequential allocation, n = 180?
Participants

180 women (not clear) attending a hospital in Southern Taiwan

Inclusion criteria: breastfeeding at hospital discharge, term, healthy infant, able to read Chinese (hospital discharge at approximately 5 days)

Interventions

Intervention 1 - telephone support: weekly phone calls for 2 weeks after hospital discharge then at 4 and 8 weeks postpartum by maternity nurse. The calls were to increase women’s self confidence.

Intervention 2 - home visits intervention: same schedule as phone support group with visits at home by the maternity nurse

Control: usual care

OutcomesBreastfeeding duration and analysis of factors affecting duration of breastfeeding
NotesWe have not included data from this study in the review as data were not reported in a way that allowed us to enter them into RevMan 2014 for meta-analysis.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High risk

Sequentially to 1 of 3 groups

 

Allocation concealment (selection bias)High riskIn sequence (could be anticipated and changed by the person carrying out randomisation)
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient detail provided to judge this.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient detail provided to judge this.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot clear: 180 women were followed up. It was not clear whether this number was randomized.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskBaseline characteristics of 3 groups were similar.

Coutinho 2005

Methods2-arm RCT, with individual randomisation N=350
Participants

The study was carried out in 2 hospitals serving urban areas and neighbouring small towns in the interior of the State of Pernambuco, north-eastern Brazil.

Background rates of breastfeeding initiation: high

Inclusion criteria: singleton infants

Exclusion criteria: infants with congenital anomalies or serious illness necessitating intensive care and those whose mothers had serious disease or mental illness or were planning to leave the area within 6 months

Approximately 60% had an income lower than the minimum wage; 33% did not have access to a flush toilet, approximately 35% of the mothers were < 20 years, 39% primiparous, approximately 28% had a caesarean delivery

Interventions

90% of maternity staff in both hospitals received the 18-h UNICEF/WHO Baby Friendly Hospital Initiative training course. All participants in the intervention and control groups received their hospital postnatal care from these Baby-Friendly trained staff.

Intervention: women (N=175) received 10 postnatal home visits (mean duration 30 min); 4 during the first month, 2 during the second month and 1 per month during the third to sixth months. Each mother was given an illustrated booklet. At each visit the home visitors observed the positioning of the infant at the breast, flow of milk and the baby’s satisfaction; encouraged exclusive breastfeeding for 6 months and continued breastfeeding for at least 2 years, and used the booklet as a basis for discussions of key topics relevant to the infant’s age. If there were any difficulties home visitors could not resolve he/she referred the mother for more specialist help at the hospital. If other family members were present, their attitude towards exclusive breastfeeding was assessed and their support was sought, including help with household chores.

Control: (N=175) usual care with no postnatal home visits

OutcomesPrimary outcome: exclusive breastfeeding. Data collected prospectively at 1, 10, 30, 60, 90, 120,150 and 180 days after birth. Any breastfeeding at same time points. The type of other fluids introduced were also recorded at each time point.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomised in blocks of 10 per town by use of a random numbers table. The random numbers were generated by the project manager, and enrolment and group assignment were made by 2 maternity-based research assistants.
Allocation concealment (selection bias)Unclear riskConcealment was achieved by drawing numbers from envelopes at the time of assignment.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: "Mothers in the trial were not close neighbours, so discussion with other mothers is unlikely, but we did not formally assess whether masking was maintained". It was not stated whether the personnel delivering the intervention were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData were collected in the trial by 4 researchers who were not aware of group allocation and were unconnected with the delivery of the interventions, however, authors did not formally assess whether masking was maintained.
Incomplete outcome data (attrition bias)
All outcomes
Low risk350 women were randomized, 175 in each group. 20 women (6%) were lost to follow-up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

The random numbers were generated by the project manager and so this may lead to bias.

Results were presented in graphs and aggregated results were not simple to interpret.

de Oliveira 2006

Methods2-arm RCT, with individual randomisation, methods unclear N=211
Participants

From maternity ward of the Hospital de Clinicas de Porto Alegre in Brazil, a university general hospital with Baby Friendly accreditation

Background rates of breastfeeding initiation high, however median duration of exclusive breastfeeding 29 days

Inclusion criteria: mothers living in the city of Porto Alegre, healthy non twin newborns with a birthweight ≥ 2500 g

Exclusion criteria: mother-infant pairs that were unable to stay together due to a health concern for either the mother or infant

Participant characteristics: ≥ 20 years old 76%, vaginal delivery 72%, white mothers 70%, > 8 years' education 64%, living with partner 83%

Interventions

Intervention (n=74) in hospital, 2 nurses reinforced the orientation about breastfeeding technique routinely given to mothers, following the WHO breastfeeding counselling principles, in a 30-min session with no more than 2 mother-infant pairs. Topics included comfortable and proper mother and infant positioning, correct attachment of the child to the breast and manual milk expression. Pictures, dolls and a model breast were used for demonstrating proper breastfeeding technique. Women also received 2 home visits from the same nurse, when the child reached 7 and 30 days of age. Infant feeding patterns, positioning, attachment, milk expression and breastfeeding problems were discussed, and breast examination performed.

Control (n=137): standard hospital care met Baby-Friendly standards. The control group appear not to have received home visits.

Outcomes

Primary outcome: number of mothers who breastfed and exclusively breastfed on maternity ward and at 30 days

Secondary outcome: frequency of breastfeeding-related problems

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskFollowing interviews and feeding assessments, mother-infant pairs were randomly assigned by pulling coloured balls from a bag indicating either the control or experimental group. After the number of mothers for the experimental group were selected, all women eligible for the study were added to the control group until the sample was complete.
Allocation concealment (selection bias)High riskBy drawing coloured balls from bags – this could be changed and it was not clear that all women in the control group were randomly allocated.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo detail provided regarding whether participants or personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "The researchers responsible for the breastfeeding evaluations did not participate in the intervention and were blinded to the group to which the mother infant pairs had been assigned.”
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk233 women were eligible, 211 followed up. (It was not clear how many were randomized.)
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Groups were described as similar at baseline, although it appeared that more women in the control group that had had previous breastfeeding experience were more likely to feed for 6 months (65%) compared to women in the intervention group (47.5%).

Unequal numbers in the intervention and control group.

The groups were not balanced (74 in the intervention group and 137 controls). It was not clear that all the women in the control group were randomly allocated.

Dennis 2002

Methods2-arm RCT, with individual randomisation, single-site study, recruiting over 10 months, n = 258
Participants

Women at home in Toronto, Canada

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: English-speaking, primiparous, ≥ 16 years, single full-term baby, intending to breastfeed,

Exclusion criteria: none specified.
Breastfeeding initiation 79%

Interventions

Intervention: telephone support by briefly-trained volunteers (2.5 h session) who had personal breastfeeding experience for at least 6 months. First contact within 48 h of hospital discharge and then as required. Mean number of contacts in those completing log-books = 5.4. Mean duration of telephone contact = 16.2 min. 97% of contacts by telephone, 3% at home.

Control: not described

OutcomesBreastfeeding (any or exclusive) at 1, 2 and 3 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomly generated numbers were provided by a statistician who was not involved in the recruitment process.
Allocation concealment (selection bias)Low riskConsecutively numbered, sealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot explicitly stated if peer counsellors were blinded but as they were recruited for the study, it is unlikely. No detail provided on blinding participants.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: “A research assistant blinded to group allocation telephoned the participants to collect data regarding current infant feeding status, breast problems encountered and health services used.”
Incomplete outcome data (attrition bias)
All outcomes
Low riskVery little loss to follow-up. 258 women randomized and 2 women lost to follow-up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo apparent differences between groups at baseline.

Di Meglio 2010

Methods2-arm RCT, with individual randomisation, n = 78
Participants

Setting: 2 hospitals in Rochester, NY, USA

Background rates of breastfeeding initiation: low

Inclusion criteria: maternal age < 20 years, uncomplicated postpartum, breastfeeding singleton infant born at gestational age > 36 weeks and weighing > 2000 g, mothers and infants discharged home together

Exclusion criteria: maternal contraindications to breastfeeding (HIV, active substance abuse), postpartum transfusion or intensive care; infants in intensive or special care unit > 6 h, infants with anomalies that interfered with breastfeeding (e.g. cleft lip or palate)

Participant characteristics: mean age 18.3 years, approximately half were African Americans, approximately one-third had private or health maintenance organisation insurance, the rest were on Medicaid or with Medicaid health maintenance organisations, > 80% were first time mothers and gave birth vaginally.

Interventions

Intervention: telephone support from trained peer supporters (teen mothers who had breastfed for > 4 weeks). Peer supporters telephoned the new teen mothers at 2, 4, 7 days and 2, 3, 4 and 5 weeks postdischarge. Peers introduced themselves and talked about the breastfeeding experience. No specific discussion topics were assigned. Peers offered their telephone numbers so that new mothers could call for support. They were advised to refer anyone with a problem to telephone resources for breastfeeding information or to their physician. Peers and women received gift voucher incentives to complete assessments and training.

Control: usual care included access to paediatric care providers and hospital LCs. The control group did not receive telephone peer support.

Outcomes

Primary outcome: ‘any breastfeeding’ duration, as measured by the age in days at complete breastfeeding cessation

Secondary outcome: exclusive breastfeeding duration, as measured by the time to the first introduction of any other supplement (water, juice, vitamins or formula)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Computer-generated random numbers

 

Allocation concealment (selection bias)Low riskQuote: “The assignment was recorded in a sealed and numbered envelope. Envelopes were sequentially opened.”
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: “In order to blind subjects to the study hypothesis, recruiters explained that this study was about: how young mothers who breastfeed in the hospitals feed their babies at home; how young mothers make feeding decisions and who helps them make those decisions.” Not clear if this attempt was successful.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: “a single research assistant conducted all the telephone interviews, using standardised, closed ended questionnaires. The interviewer had no knowledge of the study hypothesis or design.”
Incomplete outcome data (attrition bias)
All outcomes
High risk

78 randomized (38 intervention, 40 control)

In intervention group: 6 dropouts before first interview; 3 dropouts before 8-week interview; 7 dropouts between 8 and 37 weeks

In control group: 5 dropouts before first interview; 2 dropouts before 8-week interview; 9 dropouts between 8 and 21 weeks

Overall,  11 women dropped out immediately after recruitment (14%). By 8 weeks 21% lost to follow-up. 46/78 (61%) were successfully followed up to complete breastfeeding cessation (22 intervention and 24 control).

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear risk

Of the 5 adolescents who completed peer support training, there was only 1 that remained involved for the entire duration of the study.

There was very poor compliance with possibly only half of the intervention group receiving the planned intervention. The analysis is presented in diagrams that are not simple to interpret.

Study results published in 2010, data collected 1996-1997

Di Napoli 2004

Methods2-arm RCT, single-site study, mothers recruited March 2000-December 2001, n = 605
Participants

Urban Italy

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: mothers in public maternity ward in Rome, intending to breastfeed

Exclusion criteria: mothers who did not speak Italian, had no phone, breastfeeding medically contraindicated, baby in SCBU

Ethnic composition not defined. Baseline national breastfeeding initiation rate 70%.

Interventions

Intervention (home visit and telephone contact): home visit, from 1 of the 6 midwives from the maternity ward of the study hospital, took place within 7 days of hospital discharge. Telephone breastfeeding counselling session provided by the same midwife. These midwives had attended the UNICEF 18-h intensive training course on breastfeeding techniques and management.

Control: standard care (not described)

OutcomesAny breastfeeding up to 60 days
NotesExtra information about reported numbers requested and received from author.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskSample was stratified "for age and parity, and finally randomly assigned to either the intervention or control group".
Allocation concealment (selection bias)Unclear riskNot described.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details were provided about blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes
High riskA trained interviewer conducted the interviews, but was not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk605 women were randomized. Full data were available for 278 women (46%) and partial data available for a further 264 (44%). Follow-up rates for breastfeeding outcomes collected up to 180 days, but after 60 days follow-up rates were < 75% so only outcomes up to 60 days are included in this review. Reasons for drop-out were reported by group.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskBaseline characteristics similar and no apparent differences between those who refused intervention and those who received it, see Table 1.

Edwards 2013

Methods2-arm RCT, single site, n = 248
Participants

A major USA urban university hospital community doula intervention

Participant: low-income, African-American mothers < 22 years old

Breastfeeding rates: young African-American mothers continue to breastfeed at low rates, and commonly introduce complementary foods earlier than recommended. In the 2006 National Health and Nutrition Study, for example, only 30% of black adolescent mothers had ever attempted to breastfeed their infants.

Background rates of breastfeeding initiation:79%

Inclusion criteria: women who were < 34 weeks pregnant, < 21 years of age, and planning to deliver at the affiliated hospital were eligible to participate in the study.

Exclusion criteria: mothers who were aware at the time of recruitment that they would require a surgical delivery, who planned to move from the area, or who planned to give up custody of the infant

Interventions

Intervention (n=124):

Women received additional care from doulas who were women from the same communities as the women attending the clinic. During pregnancy women received weekly home visits (average = 10) where the doula focused on building a relationship with the mother and discussed pregnancy health, childbirth preparation, and bonding with the unborn infant.Doulas were present during labour to provide support and help initiate breastfeeding after birth.Doulas continued to provide face-to-face breastfeeding support in the post-natal period (average 12 home visits). Doulas undertook a 20-week doula training course provided by the Chicago Health Connection (Health Connect One) and a 10-week breastfeeding peer counsellor training programme from the same organisation.

Control (n=124): mothers received usual prenatal care; no doula input

Outcomes

Primary outcomes: data on breastfeeding attempts were collected by mother report at the hospital the second morning after the birth and from review of the nursing notes in the mothers medical chart after the mothers discharge. mothers were considered to have attempted breastfeeding if breastfeeding was indicated by either self report or nursing notes. At 4 months postpartum, the mothers participated in an interview on feeding practices. Mothers reported on whether they were currently breastfeeding and, if not, when they had stopped breastfeeding.

Secondary: mothers were also asked about whether they had started feeding their infants cereal, either in the bottle or by spoon, or other solid foods, and reported the infant age.

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "Randomization took place in blocks of 4, 6, or 8, with equal numbers assigned to the intervention and control groups."
Allocation concealment (selection bias)Low riskQuote: "A biostatistician prepared a set of opaque envelopes, each labelled with a subject ID number and containing a group assignment. Envelopes were opened by the interviewer in the presence of the mother at the completion of the baseline interview."
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible to blind participants.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData were collected by research staff through interviews with mothers and by chart review. Not stated whether research staff were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskA total of 221 mothers,113 in the control group and 108 in the doula participated in the 4-month interview. Attrition < 25% for both groups.
Selective reporting (reporting bias)High riskBreastfeeding at 12 months was reported as a secondary outcome in the Clinicaltrials.gov record, but this was not reported in the paper.
Other biasLow riskMothers in the 2 groups were compared on a variety of demographic, psychological, and health variables measured before randomisation and no significant differences were found.

Efrat 2015

MethodsParallel 2-arm RCT, single-site study, n = 298
Participants

Community health centres in Los Angeles County, USA

Participants: low-income, Hispanic women

Breastfeeding rates: local breastfeeding rates not reported but authors state that within the Hispanic population the exclusive breastfeeding rate in hospital is 27.9% and at 1 week postpartum 33% of breastfeeding Hispanic women also give their babies formula.

Inclusion criteria: women 26–34 weeks pregnant, Medicaid recipient, self-identified Hispanic, available via telephone, not assigned to a WIC peer counsellor, gave birth to a healthy full-term singleton, absence of congenital abnormality, the infant was not admitted to a NICU

Exclusion criteria: participants whose babies had medical conditions that could significantly interfere with breastfeeding. The researchers also avoided recruiting participants from health clinics located near WIC sites that offered peer support.

Interventions

Intervention (n = 146): WIC Supplemental Nutrition Programmes. The standard WIC programmes provide monthly food vouchers, nutrition education and breastfeeding support to women, infants and children aged ≤ 5 years. Breastfeeding support includes breastfeeding classes, access to a free breastfeeding helpline, breast pumps and LC service. Some programmes also offered breastfeeding and support and education using peer counsellors. The intervention group received additional support from LCs who were undergraduate students who had completed a semester-long lactation education course and 10 h of postcourse training. The lactation education course included content knowledge on the normal breastfeeding process and cultural sensitivity training. The intervention entailed 4 prenatal and 17 postpartum phone calls (first call initiated when mothers were in the third trimester of pregnancy and the last call when mother was 6 months postpartum. The intervention participants were also provided with the lactation educator’s phone number so they could contact her more frequently if need be. On occasion, text messages were used to implement phone contacts with participants.

Control (n = 143): standard WIC programme

Outcomes

Primary and secondary outcomes not distinguished.

Exclusive breastfeeding at 72 h

Any breastfeeding at 72 h

Exclusive breastfeeding at 1 month

Any breastfeeding at 1 month

Exclusive breastfeeding at 3 months

Any breastfeeding at 3 months

Exclusive breastfeeding at 6 months

Any breastfeeding at 6 months

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details provided to enable judgement of this.
Allocation concealment (selection bias)Unclear riskNo details provided to enable judgement of this.
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome data collected by the research assistants who also acted as lactation educators and were not blinded.
Incomplete outcome data (attrition bias)
All outcomes
High riskFollow-up varied between 61% and 38%.
Selective reporting (reporting bias)Unclear riskOutcomes not specified in trial registration document.
Other biasUnclear riskNone noted.

Ekstrom 2006

MethodsLongitudinal study, 2-arm cluster-randomised trial, 10 Swedish municipalities randomized n=540
Participants

Setting: Antenatal Centres and Child Health Centres in 10 municipalities in southwest Sweden

Background rates of breastfeeding initiation: high

Inclusion criteria: Swedish-speaking mothers who gave birth to singleton, healthy, term infants spontaneously, by vacuum extraction or by caesarean section

Participant characteristics: mean age approximately 27 years, married 61%-69%, vaginal delivery 70%-75%, university educated 36%

Interventions

Intervention: the intervention included continuity of care at the antenatal and child centres, and a process-oriented training program of 7 sessions for health professionals. The staff training included reflection on personal experience of breastfeeding and breastfeeding counselling, management and promotion. Staff were encouraged to develop a common breastfeeding policy between the antenatal and child health centres. The family classes were also kept together before and after childbirth.

Control: offered standard family classes, usually discontinued at birth

OutcomesMaternal perceptions of the relationship with the infant, maternal feelings for the infant and duration of exclusive/any breastfeeding
Notes10 centres randomized. A total of 540 women took part in the study (intervention group 206 women; 2 control groups 162 + 172 = 334 women). Data collection took place at different times for the 2 control groups. We have included data from 378 women; the intervention group (206 women) and 1 control group (172 women), from whom data were collected at the same time as from the intervention group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskThe 10 largest municipalities were classified in pairs that were similar in size and had similar figures of breastfeeding duration. The municipalities were randomized pair-wise to either an intervention or control group.
Allocation concealment (selection bias)Unclear riskTrial report did not report.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo detail regarding blinding of participants or personnel, but appears unlikely.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskMaternity staff distributed the first questionnaire. Follow-up questionnaires were sent to women. It was not stated whether there were any blinding procedures.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

The sample included women cared for in intervention clinics and then 2 control groups. However, data collection in 1 of the control groups was carried out before the intervention period, so in the analyses we have included only the control group data that were collected simultaneously with the intervention group (total 540 women, 378 included in analysis).

Response rates at 3 days 84% and 93% in the intervention and control groups, by 9 months postpartum 64% and 73%.

There was no adjustment for cluster design.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskNo baseline imbalance was apparent, although duration of exclusive breastfeeding was presented as a baseline characteristic.

Elliott-Rudder 2014

Methods2-arm cluster-RCT, n = 330 in 15 clusters
Participants

NSW, Australia, primary care setting of general practice in rural agricultural settings. Maternity hospitals were not Baby Friendly accredited, although at each hospital an International Board Certified LC and registered midwives encouraged mothers to breastfeed.

35.3% of infants were currently fed solids at 4 months, while 52.9% had received solids, infant formula or other nonhuman milk, at least once, by 4 months.

Background rates of breastfeeding initiation:92%

Inclusion criteria: all pregnant women who had registered to give birth at 1 of the 3 local hospitals (n = 3127) over 14 months, had reached 24–36 weeks of pregnancy, who planned to have their postnatal care at a participating general practice and who were still breastfeeding at8 weeks were randomised.

Exclusion criteria: not reported

Interventions

Intervention (n = 154): a structured conversation to support continuation of breastfeeding following a Conversation Tool flowchart that used a motivational interviewing approach. The Conversation Tool was used with each breastfeeding mother who attended a general practice intervention site for her infant to be immunised at 2, 4 or 6 months. Mothers were informed of the recommendation for breastfeeding exclusively to 6 months and maintenance to 1-2 years and asked ‘How would that work for you?’ According to the mother’s response, the practice nurse provided a targeted proactive conversational action.

Intervention practice nurses attended 2 x 5-h training workshops that were delivered by a team of a midwife/LC/trainer and a family doctor/breastfeeding counsellor and based on WHO-based resource that presented breastfeeding maintenance as appropriate and physiological. In addition, training addressed motivational interviewing and reflective practice. Information about local government and community breastfeeding support services, and handout literature for mothers, were provided.

Control (n = 176): mothers received usual care from nurses who had not received WHO breastfeeding support training, and who commonly asked whether the mother had any problems.

Outcomes

Outcomes not clearly stated

Exclusive and full/predominant (substitution of breastmilk with water-based substances allowed) breastfeeding at 4 and 6 months

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskClusters were coded, computer randomized and assigned to the intervention or control group.
Allocation concealment (selection bias)Low riskClusters randomized at same time, so concealment was not an issue.
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Blinding was not possible for the practice nurses.

Participants were unaware of the group allocation process, but not clear if this was effective.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskResearch assistants, who were not otherwise associated with the study, collected blinded outcome data by telephone interview.
Incomplete outcome data (attrition bias)
All outcomes
Low risk2% attrition in intervention group and 3% in control group.
Selective reporting (reporting bias)Unclear riskThe protocol did not state the predefined outcomes clearly.
Other biasHigh riskDifference in prenatal intentions to rejoin employment within 12 months between the 2 groups (70% intervention, 56% control).

Ellis 1984

Methods2-arm RCT, with individual randomisation n=120
ParticipantsSetting not clear: women expecting to give birth in an urban maternity unit, Canada. 120 women recruited in late pregnancy. 
Interventions

Intervention: in addition to usual care, prenatal breastfeeding class and postnatal drop-in breastfeeding session. Telephone follow-up by nurse at 2, 6 and 12 weeks postpartum. 

Control: usual care in hospital with assistance from nurses who had received breastfeeding education.

OutcomesExclusive breastfeeding at 1 and 3 months and any breastfeeding at 3 and 6 months
NotesWe have not included data from this study in the review due to high levels of attrition (> 25% loss to follow-up). Recruitment to the study took place during pregnancy and by 1 month postpartum there was high loss to follow-up and loss was not balanced across groups. At 1 month 42% of controls and 22% of the intervention group were not available for follow-up. The high level and unbalanced attrition means that results from this study were difficult to interpret.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskDescribed as “randomly assigned”.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details provided about blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskDid not state who collected the data. No details provided about blinding of outcome assessment.
Incomplete outcome data (attrition bias)
All outcomes
High riskRecruitment to the study took place during pregnancy and by 1 month postpartum there was high loss to follow-up and this was not balanced across groups. At 1 month 42% of controls and 22% of the intervention group were not available for follow-up. The high level and unbalanced attrition means that results from this study are difficult to interpret. 
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThere was very little information about study methods and most of the results in the paper were not reported by randomisation group.

Frank 1987

Methods4-arm (factorial design) RCT, single site, recruiting over 17 months, n = 343
Participants

Urban USA: inpatient maternity unit

Background rates of breastfeeding initiation: low

Inclusion criteria: breastfed once in hospital; able to speak Spanish or English; baby needed < 48 h on NICU; able to be contacted by telephone after discharge

Participant characteristics:

57% primiparous

Ethnic composition: black 65%, Hispanic 19%, white 13%, other 4%

Socioeconomic status defined by: < 100% poverty level - 69%; 100%-200% poverty level - 21%; > 200% poverty level - 10%

Mean age of participants 25.7 years

Interventions

Intervention: women received postpartum breastfeeding counselling in hospital by trained counsellor (20-40 min) and by telephone at 5, 7, 14, 21, 28, days and 6, 8 and 12 weeks, also 24-h advice by pager. Given research discharge pack in English and Spanish.

Routine care consisted of postpartum staff nursing contacts (including discharge teaching session on infant care), infrequent breastfeeding classes, written information on breastfeeding management and the opportunity to access a midwife-run telephone advice line.

Outcomes

Exclusive breastfeeding at 1, 2, 3 and 4 months

Any breastfeeding at 4 months

Median duration of breastfeeding

Time to introduction of formula or solids

Rehospitalisation of infants

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomised block design (block size 8) with computer-generated list of random numbers
Allocation concealment (selection bias)Low riskSequentially numbered opaque sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipants were aware of the overall goal of the interventions but not aware of the study hypotheses. It is not detailed whether personnel were blinded but appears unlikely.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskFor follow-up at 4 months it was stated that the investigator was not aware of group assignment.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Participants received a fee to minimise sample attrition.

343 women were recruited. There were a small number of protocol deviations (7 women received the wrong type of discharge pack and were analyzed according to treatment received rather than by randomisation group). 19 women were lost to follow-up. Attrition and reasons for attrition were described as similar across groups. Follow-up 94%. Appropriate randomisation procedures.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo baseline imbalance apparent.

Froozani 1999

MethodsSingle-site study recruiting over 7 months, n = 134
Participants

Urban Iran

Background rates of breastfeeding initiation: high

Inclusion criteria: women without breastfeeding experience or chronic disease giving birth normally at term to a healthy baby ≥ 2.5 kg

Interventions

Intervention: nutritionist trained using WHO Breastfeeding Counseling training course (40 h). Contact in hospital immediately after birth, between 10 and 15 days, after 30 days and monthly to the fourth month at home or in a lactation clinic

Control: standard care (not described)

Outcomes

Exclusive breastfeeding at 1, 2, 3 and 4 months

Mean number of days illness with diarrhoea

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAllocation by day of the week of birth.
Allocation concealment (selection bias)High riskAllocation could be anticipated in advance and different days of the week may have had different characteristics (e.g. staff on duty).
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen were not told directly which group they had been assigned to but would be aware of whether or not they had received the intervention. The nutritionist carrying out the intervention would have been aware of allocation.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThe nutritionist carrying out the intervention also carried out all the measurements and noted breastfeeding pattern at each visit.
Incomplete outcome data (attrition bias)
All outcomes
Low risk134 randomized and 120 followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskNo baseline imbalance apparent.

Fu 2014

MethodsMulticentre, 3-arm cluster-RCT, n = 722 (clusters (hospitals) n = 3)
Participants

Mother–infant pairs were recruited from the postnatal units of 3 geographically distributed public hospitals providing obstetrical services in Hong Kong.

Participants: 722 primiparous breastfeeding mothers with uncomplicated, full-term pregnancies

Background rates of breastfeeding initiation: 80%

In Hong Kong current breastfeeding patterns are similar to those of other developed countries, with > 80% of women initiating breastfeeding, but with only 20% continuing to breastfeed exclusively for 3 months.

Inclusion criteria (mother): Hong Kong Chinese primiparas, ≥ 18 years old, intending to breastfeed, and without any major obstetric complications (i.e. severe postpartum haemorrhage) or serious medical problems (i.e. psychiatric illness)

Inclusion criteria (baby): gestational age ≥ 37 weeks; birthweight ≥ 2500 g, 5-min Apgar score ≥ 8, and no physical anomalies that would contraindicate or complicate breastfeeding

Exclusion criteria: mothers who were planning to live in mainland China after delivery

Interventions

Intervention 1: standard care plus 3 in-hospital professional breastfeeding support sessions, of 30–45 min in duration

Intervention 2: standard care plus weekly postdischarge breastfeeding telephone support, of 20–30 min duration, for 4 weeks.

Both interventions were delivered by 4 trained research nurses, who were either highly experienced registered midwives or certified LCs.

Control: standard postnatal maternity care that consisted of routine perinatal care according to the type of delivery, group postnatal lactation education provided by a midwife or LC, 1-on-1 assistance with breastfeeding if problems arose and time permitted, and postdischarge follow-up, either at the outpatient clinic of the delivery hospital or at the nearest Maternal and Child Health Centre. Information on available peer-support groups was also provided upon hospital discharge.

Outcomes

Primary: prevalence of any and exclusive breastfeeding at 1, 2, and 3 months postpartum. Classified infant feeding status into 3 categories: exclusive breastfeeding; any breastfeeding; and exclusive formula feeding.

Secondary: overall duration of any and exclusive breastfeeding. Measured the duration of any and exclusive breastfeeding as the age of the infant in weeks when the participant completely stopped breastfeeding and first introduced infant formula, respectively.

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe allocation sequence was generated using an online program (www.randomization.com). All participants at each study site were allocated to the intervention to which the hospital was randomly assigned for that week. Cluster-randomisation was used, with hospitals being the unit of randomisation. Each week, a study hospital was randomly assigned each study hospital to 1 of the 3 treatment groups.
Allocation concealment (selection bias)Low riskConducted by a person not involved in the subject recruitment or data collection. Assignments placed in sequentially numbered opaque sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThe blinding of either participants or those delivering the intervention was not possible for this type of study design. For the control and telephone support group, a research nurse not involved with delivering the intervention, recruited the participants. However, authors state that for the inpatients, the same nurse who recruited the participants also delivered the intervention.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskA study research assistant, who was blinded to the participants’ treatment allocation, conducted the telephone follow-up.
Incomplete outcome data (attrition bias)
All outcomes
Low risk97% of participants had complete follow-up.
Selective reporting (reporting bias)Unclear riskNo evidence of predefined outcome measures so unable to make a judgement.
Other biasHigh risk

Not all intervention groups received the full intervention.Of the 191 participants allocated to the in-hospital support group, 137 (71.7%) received all 3 sessions, 52 (27.2%) received 2 sessions, and 2 (1.0%) received only 1 session before hospital discharge. Of the 268 participants in the telephone support group, 199 (74.3%) received all support sessions for which they were eligible; 27 (10.1%), 24 (9.0%), 13 (4.9%), and 5 (1.9%).

Baseline characteristics and maternal and birth data were similar across the 3 groups although there were some minor variations in maternal education, family income, intention to exclusively breastfeed, and antenatal breastfeeding class attendance.

Gagnon 2002

Methods2-arm RCT, with individual randomisation, n = 586, 292 assigned to intervention and 294 to control
Participants

Study conducted at a university teaching hospital and affiliated community health centres in urban Quebec, Canada. Recruitment January 1997-September 1998

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: mothers participating in hospital short-stay programme

Ethnic and socioeconomic composition of sample not reported

Baseline prevalence of breastfeeding initiation in Canada (excluding territories) 1994-5 = 73%

Interventions

Intervention: home visit from community nurse 3-4 days postpartum. Nurses were Baccalaureate prepared, had a minimum of 3 years' clinical experience in maternal-child health, and had attended training to ensure assessment skills of maternal-newborn and breastfeeding support. Contact with the nurse continued if required.

Control: usual care was a 48-h postpartum contact and 1 postpartum hospital clinic visit (day 3) following a standard plan of care and lasting up to 45 min. Referral for continued care was available.

OutcomesBreastfeeding frequency and infant weight gain assessed at 2 weeks postpartum
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBlock randomisation (block size 8) stratified by parity, by computer-generated random numbers.
Allocation concealment (selection bias)Unclear riskNot described.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "masking of the women and health professionals was not possible."
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was reported that outcome data were collected by blind investigators. It was not clear whether planned blinding was effective, although investigators apparently asked women "not to divulge their group status".
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk586 randomized. 21 protocol deviations, but analysis performed according to randomisation. 499 completed trial and provided information on primary outcome (15% attrition). Some further missing data for some outcomes.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so were unable to evaluate.
Other biasLow riskGroups described as similar at baseline.

Graffy 2004

Methods2-arm RCT with individual randomisation, conducted in 32 general practices in the UK; recruitment April 1995-August 1998, n = 720; 363 assigned to intervention and 357 to control
Participants

Urban south-east England

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: mothers considering breastfeeding who had not breastfed a previous child for 6 weeks after birth

Exclusion criteria: planning to contact a breastfeeding counsellor, address considered unsafe to visit, baby born before 36 weeks' gestation

Ethnic composition of sample: 59% white (UK) participants, 11% white (other) participants, 16% African or Caribbean, 8% Indian subcontinent, 6% other

Socioeconomic status on RG classification: 10% I, 26% II, 19% IIINM, 26% IIIM, 12% IV, 3% V, 5% other

First baby: 74%

National baseline prevalence 66% breastfeeding at birth

Interventions

Intervention: women received 1 antenatal visit from a National Childbirth Trust trained breastfeeding counsellor, who offered postnatal support by telephone or further visits if the mother requested this after the birth

Control: standard care (UK standard care includes postnatal home visits from midwives and health visitors)

OutcomesPrevalence of any breastfeeding to 6 weeks; duration of any breastfeeding to 4 months; time to introduction of formula feeds; maternal satisfaction and common feeding problems; mothers' perspectives on support from counsellors; association between counselling uptake and feeding behaviour
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskPermuted block design stratified by GP practice and parity, randomisation schedule prepared by statistician.
Allocation concealment (selection bias)Low riskNumbered sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDid not state whether participants or personnel were blinded, however, it seems unlikely due to the nature of the intervention.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskReported that responses to follow-up questionnaires were coded by blinded assessors.
Incomplete outcome data (attrition bias)
All outcomes
Low risk720 women recruited and randomized. 97% available for follow-up at birth, 93% at 6 weeks and 86% at 4 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not evaluate this.
Other biasUnclear riskGroups were similar at baseline although more women in the intervention group (16) than the control group (6) were undecided about breastfeeding intention at the antenatal assessment. It was reported that a sensitivity analysis was carried out to adjust for this possible confounder.

Gross 1998

MethodsCluster-randomised trial. 4 clinics were 'randomly assigned' to 4 different interventions n=548
Participants

Setting: 4 WIC clinics in Baltimore USA

Women were predominantly African American (> 90%)

548 women attending study clinics enrolled at between 6 and 24 weeks’ gestation. Women were WIC eligible with singleton pregnancies, planning to keep the baby and to stay in study areas

Interventions

The study was carried out in 4 clinics. Each clinic offered a different intervention.

Clinic 1: standard care (usual breastfeeding promotion by clinic staff)

Clinic 2: standard care plus a motivational video (encouraging breastfeeding) that was played repeatedly in the clinic waiting area

Clinic 3: peer support by a mother who had breastfed and undertaken training. Peer supporters contacted pregnant women and discussed breastfeeding. Women were offered a 1-h group breastfeeding support session in the WIC clinic before the birth. After the birth, peer counsellors contacted women and remained in contact with breastfeeding women (phone or visits) until 16 weeks after the birth.

Clinic 4: standard care plus video plus peer support

OutcomesInfant feeding method at 8 weeks and 16 weeks postpartum and maternal work status
Notes

We were not able to include data from this study in the review due to very high levels of attrition. The study was at a high risk of bias. This was a cluster trial with 4 clinics each allocated to a different intervention and with no adjustment for study design effect.

Women were recruited in the antenatal period. 548 women enrolled but information was only available for 273 women at 7-10 days postpartum (50%); of the 275 women lost to follow-up 31% (74) were excluded due to pregnancy complications, the remaining 73% (201 women) refused or could not be contacted – these women represented 37% of the original randomized sample. It was not clear whether loss was similar in the 4 clinics.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskCluster trial. 4 clinics;  method of randomisation not described
Allocation concealment (selection bias)Unclear risk

Not described

 

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDid not state whether participants or personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskDid not state who the interviewers were or if any attempt at blinding outcome assessment was made.
Incomplete outcome data (attrition bias)
All outcomes
High risk548 women were enrolled on the study, but information was only available for 273 women at 7 to 10 days postpartum (50%); of the 275 women lost to follow-up 31% (74) were excluded due to pregnancy complications, the remaining 73% (201 women) refused or could not be contacted – these women represented 37% of the original randomized sample. It was not clear whether  loss was similar in the 4 clinics.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not evaluate this.
Other biasUnclear riskBaseline characteristics: imbalance for educational status, employment and parity - although these were adjusted for in the analysis.

Grossman 1990

Methods2-arm quasi-RCT, with individual randomisation, single-site study recruiting over 10 months, n = 97, follow-up 90%. Quasi-randomisation via coin toss, with women sharing same room allocated by 1 toss
Participants

Urban USA - inpatient maternity unit

Background rates of breastfeeding initiation: low

WIC breastfeeding prevalence at birth 1991 = 33%

Inclusion criteria: women eligible for WIC programme services for those on low incomes; women intending to breastfeed

Participant characteristics: approximately one-third were primiparous.

Ethnic composition described as 54% black.

Mean age was 25.4 years.

Interventions

Intervention: package included 30-45 min face-to-face meeting in hospital with LC (a registered nurse) after birth - educational booklet given; telephone contacts on days 2, 4, 7, 10 and 21; a telephone help-line staffed by a nurse or paediatrician; and back-up support for those with problems from a lactation clinic

Control: routine postnatal teaching on infant care and feeding by obstetric nursing staff

Outcomes

Rates of breastfeeding at 6 weeks and 3 and 6 months

Median duration of breastfeeding

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskCoin toss at the point of randomisation.
Allocation concealment (selection bias)High riskCoin toss at the point of randomisation, so allocation could be altered. If 2 women occupied the same room they were allocated to the same group.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDid not state whether women or personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskSome data were derived from medical records, but telephone outcome assessment was not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk97 women randomized, by 6 weeks 4 control group women could not be contacted (> 90% follow-up but loss not balanced across groups).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not evaluate this.
Other biasUnclear riskGroups appeared similar at baseline.

Haider 2000

MethodsCommunity-based cluster-randomised study (40 adjacent areas randomized), recruitment over 10 months, n = 726
Participants

Setting: Dakka, Bangladesh

Background rates of breastfeeding initiation: high

Socioeconomic status: mainly lower-middle and low

Inclusion criteria: women aged 16-35 years with ≤ 3 children (or ≤ 6 pregnancies) and no serious illness

Exclusion criteria: multiple births, children with congenital abnormalities, and those weighing < 1800 g

National baseline prevalence reported in paper was similar to the control group rates; UNICEF quoted higher rates - 53% exclusive breastfeeding at 0-3 months

Interventions

Intervention: peer counselling by women with personal breastfeeding experience trained over 40 h with the WHO/UNICEF Breastfeeding Counseling course. Paid honorarium. Supervised caseload of 12-25 mothers. 15 home visits: 2 in last trimester/4 in month 1/2-weekly in months 2-5. Duration of visits 20-40 min.

Control:not specified

OutcomesExclusive breastfeeding at birth, 4 days, 4 weeks, 2, 3, 4 and 5 months.
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandom number tables
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and counsellors aware of group assignment.
Blinding of outcome assessment (detection bias)
All outcomes
High riskInterviewers collecting outcome data would also be aware of assignment.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk40 areas randomized (20 intervention, 20 control) 726 women randomized. 653 available to follow-up at delivery (90%). 573 available at 5 months (79%). Loss appeared balanced across groups. No ITT analysis.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not evaluate this.
Other biasLow riskNo differences in baseline characteristics apparent. Staed that results were based on individual level analysis, but with adjustment for cluster level of randomisation.

Hall 1978

Methods3-arm RCT n=49
Participants49 women giving birth in a small community hospital in the USA planning to breastfeed for at least 6 weeks and breastfeeding for the first time. All women had healthy babies. Women were described as married and middle class aged 17–31 years
Interventions

3 groups:

Intervention 1: 15 randomized, 13 followed up (not clear): usual care plus an educational session

Intervention 2: 16 randomized, 15 followed up (not clear): usual care plus education plus daily visits by nurse while in hospital and telephone support 2 days after discharge and 1 week later and further support if necessary (up to 5 weeks postpartum).

Control: 18 randomized, 12 followed up (not clear)

OutcomesOutcomes were unclear, but included breastfeeding at 6 weeks and breastfeeding problems.
NotesWe have not included data from this study in the review due to methodological weakness and high and unbalanced levels of attrition. More than 30% of the control group were lost to follow-up and results were therefore difficult to interpret. Most results were not reported according to randomisation group and the only result for breastfeeding duration was approximate, stating: “Approximately 50% of the control group and 50% of the group which received the teaching unit were still nursing at 6 weeks. Of the group who received the teaching plus support 80% were still nursing at 6 weeks.” 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described.
Allocation concealment (selection bias)Unclear riskDescribed as 'randomly assigned'.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome assessment was not by the same nurse as the 1 delivering the intervention, but unclear if they were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskThere was high attrition in this small study, > 30% of the control group were lost to follow-up and results were therefore difficult to interpret.
Selective reporting (reporting bias)Unclear riskMost results were not reported by randomisation group.
Other biasUnclear riskNo baseline characteristics reported.

Hanson 2015

Methods2-arm cluster-RCT, whole population in 132 wards (clusters)
Participants

Setting: rural Tanzania. Most residents were subsistence farmers living in small settlements (subvillages) and 90% lived within 5 km of primary facilities.

Background rates of breastfeeding initiation: not stated

Inclusion criteria: households in intervention and comparison wards with live births. If the village had fewer than 130 households, all households in the village were included.

Exclusion criteria: If the village had greater than 130 households, segmentation was used to limit the sample to a maximum of 131 households.

Interventions

Intervention: home-based counselling - this strategy, branded Mtunze Mtoto Mchanga, which means "protect your newborn baby" in Swahili, was developed in 20082009. The strategy was designed in consultation with the Ministry of Health and members of the WHO, UNICEF, and professional organisations. Key counselling messages were selected on the basis of the frequency of the behaviour in 2007 the feasibility of change, and the likely impact on survival on the basis of evidence published at the time. They included hygiene during childbirth, early and exclusive breastfeeding, and extra care for low-birthweight babies, including skin-to-skin care.

Control: usual practice

Outcomes

Primary: all-cause neonatal mortality rate, per 1000 live births, defined as the proportion of all live births who died in the first 28 days of life

Secondary:

Breastfeeding within an hour of delivery;

Soap or use of gloves for those attending home deliveries;

Exclusive breastfeeding for 3 days after birth;

Skilled attendance at birth;

Birth preparedness;

Immediate drying and covering of the baby;

Clean cord care;

Delayed bathing;

Identification and extra care for small babies, including skin-to-skin care for small babies and referral to hospital for very small babies

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomisation was performed using STATA" (p.8).
Allocation concealment (selection bias)Unclear riskNo information provided to enable us to judge this.
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded to the intervention. Volunteers who provided the intervention were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "The survey team was unaware of cluster allocation. The data analyst was masked to the cluster allocation until data cleaning was complete and a copy of the data lodged with the data and safety monitoring board". Unclear if these procedures were effective.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskProbably high as the data were obtained retrospectively in the 2013 survey and results from the previous year were used in the data analysis. Six of the sampled sub-villages refused to participate. In 6% of households no one was present, 1% of households refused to participate.
Selective reporting (reporting bias)High riskBreastfeeding was not a prespecified outcome in the clinicaltrials.gov record.
Other biasHigh riskRisk of contamination, quote: "Methodological limitations include our inability to rule out some degree of leakage of the intervention into the comparison areas and response bias for newborn care behaviours".

Hoddinott 2009

Methods2-arm cluster-RCT with prospective mixed method embedded case studies to evaluate implementation processes. 14 localities randomized; recruitment 2002-2004 n=18858
Participants

Setting: women registered at GP practices in 14 localities (of 66) in Scotland

Background rates of breastfeeding initiation: low

In Scotland, in 2005, only 44% of babies had received any breast milk at 6 weeks.

14 clusters randomized, birth records supplied data for n = 9747 in intervention group and n = 9111 in control group.

Inclusion criteria: pregnant women and breastfeeding mothers

Exclusion criteria: not stated

In intervention localities 25.2% of the populations were in the most deprived social groups, compared with 32.1% in the control localities. Mean age of mothers at the first child health record was 28-29 years. In 7 areas (3 intervention, 4 control) women gave birth at Baby-Friendly hospitals.

Interventions

Intervention: a policy intervention aimed at locality areas rather than at individual women. The policy aimed to double the number of local breastfeeding support groups and to make weekly support groups open to all pregnant women and breastfeeding mothers. These local breastfeeding support groups were facilitated by health professionals taking a woman-centred approach and aiming to provide breastfeeding support and social interaction for women. 

Control: control localities received no additional intervention; however, breastfeeding support groups existed in some control areas.

Outcomes

Primary: number of babies receiving any breast milk at 6-8 weeks, as reported in routinely collected data for the 2 pretrial years and 2 trial years

Secondary: any breastfeeding at birth, 5-7 days and 8-9 months, and maternal satisfaction

Results were not presented in a way which allowed us to enter them into data and analysis tables, but we have summarised findings in the text.

NotesWhen we updated our search in October 2011, Hoddinott 2009 was the only evaluation we found: a) of a policy-level intervention; b) of breastfeeding in groups; and c) that used routinely collected locality-level outcome data.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCluster-RCT; 14 localities randomized. Localities varied in size, baseline breastfeeding rates and numbers of pre-existing groups and how pregnancy and postnatal care were organised. Localities were matched on breastfeeding rates and existing support groups: quote: “An independent statistician used random number tables to randomise locality pairs to either intervention or control”. 
Allocation concealment (selection bias)Low riskResearchers analysing primary and secondary outcomes were blinded to allocation, ensured by coding of localities.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCluster-randomised trial, so women may not have been aware of the study although they would be aware of the intervention. Not stated whether personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskResearchers analysing primary and secondary outcomes were reported to be blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAccording to flow chart no clusters discontinued the intervention or were lost to follow-up and there was follow-up of national data in all localities included in the trial. The amount of data missing varied for different outcomes (e.g. birth and 6 week postpartum records were available for most of the eligible population but child health records at 8-9 months were only available for approximately a quarter of the children).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskAnalysis took into account aspects of design effect. It appeared that there were some differences in the localities at baseline. Control localities may have had higher levels of social deprivation.

Hoddinott 2012

Methods2-arn RCT, single-site study, n = 69
Participants

Setting: a maternity unit serving a mixed urban and rural population in Scotland

Background rates of breastfeeding initiation: at hospital discharge, 54% of babies were exclusively breastfed and 6% were receiving breast and formula milk. In the most disadvantaged areas, 39% exclusively breastfed compared with 63% in the most advantaged areas.

Inclusion criteria: women admitted to the ward between 26 July-18 October 2010 who lived in the 3 most disadvantaged postcode area quintiles for the Scottish Index of Multiple Deprivation (SIMD 1-3) in 2009 and who were breastfeeding

Exclusion criteria: women aged < 16 years with serious medical or psychiatric problems or with insufficient spoken English to communicate by telephone

Interventions

Intervention (n = 35): proactive telephone calls (intervention) daily for 1 week following hospital discharge. Calls were terminated at the woman’s request or if breastfeeding ceased. At 1 week following discharge, women could choose to continue receiving daily calls for a further week, change the frequency of calls, or have no further calls. Women could telephone the feeding team at any point over the 2 weeks following discharge. Text and answer phone messaging was available. All proactive calls stopped 14 days after hospital discharge.

Control (n = 34): reactive telephone calls; women could telephone the feeding team at any point over the 2 weeks following discharge. Text and answer-phone messaging was available.

OutcomesAny breastfeeding at 6-8 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Using a website randomisation sequence service set up by an independent statistician. Randomisation was stratified to ensure balance of primiparous and multiparous women across both trial arms."
Allocation concealment (selection bias)Low riskPerformed by an independent statistician.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "Although not informed of the randomisation outcome, women knew if they had been randomized to the proactive group as they received a phone call from the feeding team within 24 h of hospital discharge". Healthcare professionals providing intervention would have been aware of allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcomes were collected by telephone by a researcher who was blind to randomisation and who had no other contact with study women.
Incomplete outcome data (attrition bias)
All outcomes
High risk3/35 in the intervention group and 8/34 of those in the control group did not have data at follow-up.
Selective reporting (reporting bias)Unclear riskNo evidence of outcomes being prespecified anywhere, so difficult to judge this.
Other biasHigh riskWomen in the proactive call group were a year older on average, with more living in the most disadvantaged postcode areas (SIMD 1). Hospital stays were half a day longer on average in the proactive call group; however, data were imbalanced by a small number of women with unusually long hospital stays. Otherwise the randomized groups were similar for parity, method of delivery, gestation and admission to the neonatal special care unit.

Hopkinson 2009

Methods2-arm RCT, n = 522
Participants

A large metropolitan hospital in Houston, Texas, USA, serving predominantly immigrant Hispanic women (85% monolingual Hispanic)

Background rates of breastfeeding initiation were high in this study population.

Inclusion criteria: mothers of low-risk infants, mixed feeding in hospitals, had telephones and access to transportation

Exclusion criteria: infants with elevated risk for hyperbilirubinaemia (preterm, discharged at < 48 h old, jaundice within 24 h of birth, Rhesus-incompatibility, cephalohematoma, positive Coombs test, family history of disorders of red blood cell enzyme defects, or defects of red blood cell shape and size)

Participant characteristics:

Mean maternal age: intervention group 26.8 years, control group 27.1 years

Mean parity: intervention group 1.5, control group 1.5

Mothers born in the USA: intervention group 2.8%, control group 1.1% (most of the women were born in Mexico or Central America)

Interventions

Intervention: mothers were given an appointment to visit the hospital-based breastfeeding clinic at 3-7 days postpartum. At the breastfeeding clinic, peer counselling sessions included a breastfeeding history, breast examination, infant oral-motor assessment, measurement of infant weight, evaluation of latch and milk transfer, and discussion of the mother's concerns and support system. Additional visits and telephone consultations were provided if deemed necessary by the mother and the clinic staff. Women who missed appointments received a telephone call.

Control: received usual care, which included bedside breastfeeding assistance before hospital discharge and the phone number of the hospital breastfeeding clinic with instructions to call if needed.

Outcomes

Primary: exclusive breastfeeding at 1 month

Secondary: volume of formula given by mothers who were mixed feeding, and incidence of breastfeeding problems

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk

Generated by random number table.

 

Allocation concealment (selection bias)Low riskAfter participants had given informed consent, the group was determined using opaque, sealed envelopes containing assignments generated by random table number. The envelope was opened by the mother.
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were not blinded as the envelope was opened by the mother. Caregivers were also not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskFor outcome assessors, outcomes were determined by telephone survey at 4 weeks postpartum by interviewers blinded to group assignment.
Incomplete outcome data (attrition bias)
All outcomes
Low risk522 randomized (255 in intervention group and 267 in control group. 55 women were lost to follow-up at 4 weeks (10.5%). Loss was balanced in the 2 groups. Issues around incomplete data were addressed.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol so could not judge this.
Other biasLow riskThere were slight baseline differences between the control group and the experimental group. Women in the intervention group were more likely to have an emergency caesarean, and were taller. Due to low compliance with the intervention, secondary analysis was carried out, but we have reported data from the primary analysis (unadjusted).

Howell 2014

Methods2-arm RCT, single site, n = 540
Participants

Black and Latina women who had delivered at a large tertiary hospital located in New York City, USA

Background rates of breastfeeding initiation: not stated

Inclusion criteria: participants were black/African American or Latina/Hispanic, spoke English or Spanish, had a working telephone, ≥ 18 years old, and had infants with birthweights > 2500 g and 5-min Apgar scores > 7

Exclusion criteria: not specified

Interventions

Intervention (n = 270): The intervention used a behavioural educational approach and aimed to prepare and educate mothers about postpartum symptoms and experiences provide social support, and develop self management skills. The intervention was delivered in two parts. The first part was delivered whilst the women was in hospital by a social worker who reviewed an education pamphlet and partner summary sheet with each mother. Education materials provided information about post-partum care and included information on breastfeeding and breast/nipple pain.. Additional information was provided on social support. The second part was a 2-week postdelivery call, where the social worker assessed patients’ symptoms, skills in symptom management, and other needs. Patients and the social worker created action plans to address current needs that included assessment of community resources.

Control: enhanced usual care; participants received a list of community resources and received a 2-week control call

OutcomesDuration and exclusivity of breastfeeding at 6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible
Blinding of outcome assessment (detection bias)
All outcomes
Low riskData were collected in person at baseline and by telephone during follow-up interviews by bilingual clinical research co-ordinators who were blinded to intervention status.
Incomplete outcome data (attrition bias)
All outcomes
Low risk79.3% of intervention group and 77.4% of control group had data available at 6 month follow-up.
Selective reporting (reporting bias)Unclear riskNot clear
Other biasLow riskBaseline sociodemographic, clinical, psychosocial, and breastfeeding characteristics were similar among intervention vs control subjects. There were no clinically important differences between intervention and control groups in baseline sociodemographic, clinical, and psychosocial characteristics, except that comorbid conditions were more prevalent among the control subjects than intervention subjects (27% vs 20%; P < .05).

ISRCTN47056748

Methods2-arm RCT, single centre, single blind, recruitment 2005-2006 n=182
Participants

Setting: maternity unit in Northern Ireland with Baby-Friendly accreditation

Background rates of breastfeeding initiation: intermediate, one-fifth of women were reported to have stopped breastfeeding before hospital discharge.

Participants randomized n = 182
Inclusion criteria: primigravid women who attended for antenatal care when 20 weeks pregnant, intended to give birth at the study hospital and consented to participate

Exclusion criteria: women < 20 years old who had commenced the ‘young mums’ parentcraft programme prior to the 20-week visit. Vulnerable women, e.g. women who neither spoke nor understood English. Mothers separated from their babies, for example when a baby was admitted to the neonatal unit, who did not receive routine instruction (postrandomisation exclusion).

Sample characteristics for n = 144 who completed the research (not reported by randomized group):

Age 21-30 years: 79/144 (55%)

Age 31-40 years: 53/144 (37%)

Socioeconomic status: 38 (26%) professionals; 20 (14%) not working 

Interventions

All study participants received standard care at the study hospital, this met Baby-Friendly standards and complied with National Institute for Clinical Excellence (NICE) guidelines.

Intervention: staff training; women (n = 93) received a 'motivationally enhanced' version of control group care from staff who had been trained in a programme called ‘Designer Breastfeeding’.

Control (n = 89): women received a 2-h antenatal infant feeding class, a breastfeeding book and midwife support for the first 3 postnatal weeks.

Outcomes

Primary: women’s motivational profile was measured, using 7-point Likert scales, in relation to 3 motivational factors: total value placed on breastfeeding, perceived midwife support, and expectancy for successful breastfeeding.

Secondary: breastfeeding behaviour on discharge from hospital and at 3 weeks postnatally. Breastfeeding initiation was defined according to the Department of Health as giving 1 breastfeed or 1 episode of expressed breast milk. Duration of breastfeeding was categorised in accordance with the Index of Breastfeeding Status, which classifies breastfeeding on a scale in accordance with the amount of breast milk the infant receives

NotesOnly 53/89 women randomized to the control group were known to have initiated breastfeeding. In the intervention group 57/93 women randomized initiated breastfeeding.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "Prior to recruitment a randomized table was created."
Allocation concealment (selection bias)Low riskThe authors state: "Neither the researcher, nor the research participants could predict their allocated treatment".
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDescribed as single blind. Women were said to be not aware of groups, but there were stickers on the notes so care providers would be aware of group assignment.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details available about who collected outcome data to enable us to judge this.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk234 assessed for eligibility, 182 consented and 144 completed.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskThere were some baseline differences between groups. Women in the control group were more likely to be discharged from hospital early and were less likely to attend antenatal infant feeding classes. It is not clear what impact these differences had on the results.

Jenner 1988

MethodsQuasi-RCT, recruitment location/duration not stated, n = 38
Participants

UK white, working-class women 19-32 years old, living with partner and intending to breastfeed

Background rates of breastfeeding initiation: intermediate: prevalence of breastfeeding in 1985 = 64% at birth and 26% at 4 months

Interventions

Intervention: 3 antenatal home visits/1 hospital visit/1 'immediate' home visit and 1 or 2 further home visits 'in the early weeks'; plus face-to-face and telephone support by a single lay supporter (mother/previous breastfeeding experience, but no indication of training)

Control: 1 antenatal home visit and 1 postnatal hospital visit

OutcomesBreastfeeding at 3 months. Partial breastfeeding grouped with formula feeding as 'breastfeeding failure'
NotesModerate-to-high risk of bias
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAlternation
Allocation concealment (selection bias)High riskAlternate allocation
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding was not attempted.
Blinding of outcome assessment (detection bias)
All outcomes
High riskBlinding was not attempted.
Incomplete outcome data (attrition bias)
All outcomes
Low risk38 women included. It appeared that all were followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol to judge this.
Other biasUnclear riskVery little information available about study methods.

Jolly 2012a

Methods2-arm cluster-controlled trial, n = 1267
Participants

Primary Care Trust health district (PCT) in Birmingham, UK

Background rates of breastfeeding initiation: 58%, with continuation rates poorly collected, but considered to be lower than national average

Inclusion criteria: all pregnant women registered with a GP within the PCT, with an estimated delivery date between 1 February 2007-31 July 2007

Exclusion criteria: none stated

Interventions

Intervention (n = 1267): antenatal peer support offered to all women in intervention clusters to encourage breastfeeding initiation, and postnatal peer support for women who initiated breastfeeding to increase continuation. Community peer support workers were employed and trained by the breastfeeding personnel in the PCT in line with WHO/UNICEF Baby Friendly breastfeeding management course. Antenatal support was aimed to be 2 support sessions (at least 1 at home, although almost all actually took place in the clinic/Children’s Centre setting). The support workers were informed when the women were discharged from hospital so that they could contact and visit them within 24 h–48 h. Further contact would be needs-based, but with a minimum of 1 more contact in the first week. Additional needs-based contacts could be by telephone or home visits.

Number randomized = 1267 (416 consented to follow-up at 6 months, and 271 of these responded at 6 months)

Control (n = 1370): routine maternity care.

Number randomized = 1370 (432 consented to follow-up at 6 months, 301 responded at 6 months)

OutcomesAny breastfeeding and exclusive breastfeeding at 10–14 days, 6 weeks and 6 months and 6 months
Notes

The numbers randomized in this paper do match the MacArthur paper which states:

Intervention: n = 1140 deliveries

Women with data on initiation of breastfeeding n = 1083

Women who initiated breastfeeding n = 747

Comparison: n = 1371 deliveries

Women with data on initiation of breastfeeding n = 1315

Women who initiated breastfeeding n = 896

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskPractices were "randomized by the trial statistician with stratification by midwifery team and numbers of deliveries per clinic". Unclear how the sequence was generated.
Allocation concealment (selection bias)Unclear riskNo details provided to allow us to assess this.
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen were aware of allocation at recruitment.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskWomen’s options for 6 month follow-up were by postal questionnaire in English, or by telephone in their language of choice by a researcher blinded to the trial allocation. Unclear whether the questionnaire would have contained identification related to allocation.
Incomplete outcome data (attrition bias)
All outcomes
High riskWhen based upon the number of women who consented to be followed up at 6 months, the follow-up was 69.7% in the intervention group and 65.1% in control group. When based on the number actually in the clusters this number is 21.4% in intervention group and 20.5% in the control group.
Selective reporting (reporting bias)Low riskOutcomes in paper match those prespecified in ISRCTN registry.
Other biasLow riskNone identified

Jones 1985

MethodsQuasi-RCT, individual randomisation, single-site study; recruitment period 18 months, n = 678
Participants

Maternity department of UK district general hospital

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: all women who attempted at least 1 breastfeed

Exclusion criteria: birth of child overlapped intervention and control periods

55% of the sample were primiparous. Ethnic composition not stated. Socioeconomic status defined by UK census categories (I and II 22%, III 46%, IV and V 13%)

Interventions

Intervention (n = 228): individual support and problem solving by lactation nurse in hospital and at home. Duration of the intervention not specified.

Control (n = 355): not specified

Outcomes

Breastfeeding rates at 4 weeks, and 3, 6 and 12 months

Satisfaction with care and intention to breastfeed after next pregnancy

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAlternating 2 week periods (i.e. 2 week intervention recruitment period, 2 week control recruitment period)
Allocation concealment (selection bias)High riskThe randomisation method did not achieve balanced group size; 228 in the intervention group vs 355 controls.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBlinding of participants and personnel not described.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskStated that 12 month follow-up was conducted by an independent interviewer.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

678 women randomized and 649 available to follow-up (96%).

Potential confounder: late exclusion of 66 women because of overlap of recruitment periods, and group sizes were uneven.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskThe method of recruiting intervention and control women appeared different; possibly face-to-face for intervention group but records not clear for the control group.

Kaojuri 2009

MethodsNot clear; described as 'case control randomized trial', 2-armed n=120
Participants

Setting: Tehran, Iran; mothers and babies recruited in a Baby Friendly accredited hospital. 120 women (baseline characteristics not described)

Inclusion criteria: women giving birth to singletons by caesarean section only

Exclusion criteria: infants with congenital abnormalities or serious illness necessitating intensive care, and mothers who had a serious illness or were planning to leave the area within 6 months, infants weighing < 2500 g at birth

Interventions

Intervention: 4 postnatal home visits (not clear)

Control: standard care (not clear)

Outcomes

Follow-up interviews by telephone on days 90, 120, 150 and 180

Results were not reported in a way in which we can include them in the review. Authors reported that "the patterns of exclusive breastfeeding in the 2 groups for days 3 to 180 differed significantly (P < 0.0001) with a mean aggregated of 67.72% among the group assigned home visits compared with 31.78% for the group assigned none".

NotesWe have not included data from this study in the review. Results were difficult to interpret and data were not reported in a way that allowed us to include them in meta-analyses.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding of participants/professionals reported.
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding of participants/professionals reported.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot clear, 120 women were recruited but it was not clear how many were followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear risk

Did not state what was included in the telephone interview.

Results reported on exclusive breastfeeding (not reported in a form we can use in the review).

Khresheh 2011

Methods2-arm RCT, recruited August 2008-April 2009, n = 140
Participants

Recruitment from postnatal wards of 2 hospitals in South Jordan

Prevalence of 'ever breastfed' in country: 93% (WHO Global Data Bank on Breastfeeding, accessed 12 Oct 2011). Paper stated that traditionally most women initiate breastfeeding and breastfeed for up to 2 years, with 32% fully breastfeeding for > 6 months.

Inclusion criteria: primiparous women following vaginal delivery with term infants

Exclusion criteria: women who lived outside the study area or who could not be contacted by phone

Interventions

Intervention: women received a 1-h education session approximately 2 h after the birth. The session included demonstrations of breastfeeding. Mothers were encouraged to ask questions and were given a pamphlet on breastfeeding. At 2 and 4 months postpartum women were contacted by phone by the same researcher/nurse. The purpose of calls was to offer support, monitor breastfeeding practices and identify any problems.

Control: usual care; women were given an appointment for 6 weeks after discharge to attend the maternal and child health services for support and follow-up. Paper states most women did not return for these appointments and were not receiving any postnatal care. Control group women did not receive postnatal home visits from a midwife or a child health nurse.

Outcomes

Primary: exclusive breastfeeding at 6 months and breastfeeding knowledge

Secondary: infant hospital admissions for diarrhoea and vomiting or respiratory tract infections

NotesDue to high levels of attrition (36%) we have not included outcome data from this study in the review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Low riskPaper stated randomisation occurred by women selecting 1 envelope from a group of sealed opaque envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThe researchers carried out the intervention and would have been aware of allocation. No details provided regarding whether mothers were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding described and it appears that the same researchers who collected data also carried out recruitment and delivered the intervention.
Incomplete outcome data (attrition bias)
All outcomes
High riskSerious loss to follow-up. At 6 months, follow-up was 62.5% in the intervention group and 66.2% in the control group.
Selective reporting (reporting bias)Unclear riskNot apparent
Other biasUnclear riskData collection procedures varied at 6 months. Some women were visited at home while others were telephoned. It was not clear how many women in the control and intervention groups were telephoned vs visited. The different data collection procedures may have affected responses.

Kools 2005

Methods2-arm cluster-randomised study with 10 sites, divided into 2 groups, which had similar numbers of births and breastfeeding rates. Recruitment December 2000-December 2002, n = 781, 408 women in sites assigned to the intervention and 373 in sites assigned to the control
Participants

Child healthcare centres in Limbourg province, the Netherlands

Background rates of breastfeeding initiation: high

Inclusion criteria: mothers applying for maternity care at any of the 10 centres

Exclusion criteria: birthweight < 2000 g

Ethnic composition not defined. Baseline prevalence of breastfeeding initiation was 80% in the Netherlands in 2002.

Interventions

Intervention: programme with 3 elements: structured health counselling by maternity and child healthcare nurses and physicians; booklet to transfer information between caregivers and between mother and caregivers and used at each consultation; lactation consultancy available via caregiver faxing consultant with details of problem (LC would then contact the caregiver or mother within 24 h of receiving the fax).

Control: not specified

OutcomesExclusive and complementary breastfeeding rates at 3 months; determinants of breastfeeding at 3 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBy coin flip
Allocation concealment (selection bias)Low riskClusters were randomized after sites were paired for similarity of breastfeeding rates and the number of births in each centre.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details provided about whether women and personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details provided about whether the caregivers (who collected some of the data) or those responsible for conducting the questionnaires were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk20 centres and 781 women were randomized. Data available for 701 for the first follow-up (90%) and 683 (87%) at 6 months postpartum.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasLow riskAnalyses adjusted for cluster effect by multi-level analysis. No baseline imbalance apparent.

Kramer 2001

MethodsMulti-site cluster-randomised study, recruitment period 19 months, n = 17,046
Participants

Urban and rural sites within Belarus

Background rates of breastfeeding initiation: high

Inclusion criteria: intention to breastfeed, healthy mother, child ≥ 2500 g at term, Apgar ≥ 5 at 5 min

Baseline breastfeeding prevalence 50% at 3 months

Interventions

Intervention: WHO/UNICEF BFI training for all staff dealing with mothers and babies in hospitals and community polyclinics. Infants seen monthly for polyclinic well-child visits and whenever ill.

Control: staff did not receive the training

Outcomes

Any breastfeeding at 3, 6, 9 and 12 months

Incidence of respiratory, gastrointestinal infection, and atopic eczema in first year

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCluster-randomised trial with double randomisation procedure. Random number tables were used to ascribe numbers to sites and higher/lower numbers were used to allocate sites to A or B interventions. Then later, in public, a coin flip was used to determine whether A or B would be intervention or control sites.
Allocation concealment (selection bias)Low risk2-stage randomisation procedure
Blinding of participants and personnel (performance bias)
All outcomes
High riskPersonnel working in the hospital were not blinded. It was not stated whether the women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe paediatricians carrying out the interventions were aware of the status of the study infants. An audit was carried to assess data validity, but it was not clear what this identified.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk34 sites randomized, 2 of which refused to carry out allocated intervention and 1 clinic falsified outcome data and was excluded. 31 sites contributed data. In addition, follow-up data were missing for 3.3% of women.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this
Other biasUnclear risk

A steering group ensured that "control sites did not institute any changes that would render their maternity hospitals or polyclinics more baby friendly".

Analysis took account of cluster design.

Groups appeared similar at baseline.

Kronborg 2007

MethodsCluster-randomised, 2-community-based trial; 22 municipalities randomized to intervention and control clusters n= 109 Health visitors and 1588 women
Participants

Western Denmark, urban and agricultural areas

Background rates of breastfeeding initiation: high. The 5 hospitals serving the area had adopted UNICEF/ WHO Baby Friendly Hospital Initiative standards, and 3 of the 5 were accredited at the time of the study.

Inclusion criteria: Danish mothers who lived in the 22 municipalities and gave birth to a single child with gestational age of ≥ 37 completed weeks

Participant characteristics: 36% primiparous, 7.5% multiparous with previous short breastfeeding experience

Interventions

Usual care included hospital care at hospitals working to Baby-Friendly standards, and an existing Health Visitor service in all municipalities.

Intervention cluster: 1-3 structured home visits within the first 5 postnatal weeks from Health Visitors with additional training. Main topics for the first visit were effective breastfeeding technique and learning to know the baby; for the second visit, self-regulated feeding and interpretation of the baby's cues; for the third visit, sufficient milk and interaction with the baby. Mothers were also given a booklet about how to breastfeed and how to read the baby's cues.

Control cluster: Health Visitors' usual practice consisting of 1 or more non-standardised visits

OutcomesDuration of exclusive breastfeeding and mother’s satisfaction with breastfeeding
NotesThe authors did not adjust for cluster design effect. In our data and analysis tables we have adjusted the sample size and event rates to take account of the design effect. We calculated an effective sample size by dividing figures by the design effect – calculated using the ICC for breastfeeding cessation given in the paper: ICC = 0.02.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe 22 clusters were stratified according to their number of births the year before the trial, and within 3 strata, 11 municipalities were randomized to the intervention group and 11 to the comparison group. The randomisation was computerised and done independently of the investigators.
Allocation concealment (selection bias)Low riskAs for the sequence generation
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and caregivers were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe health visitors provided the mothers with questionnaires which appear to have been self-completed as the mothers were asked to return the questionnaire in a stamped addressed envelope. The identity of the health visitors was blinded to the investigators and it is not clear whether this partial blinding was effective.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk22 municipalities were randomized. 2186 women had babies during the study time period. 1760 women were followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear risk

Reported that there were no significant differences between groups at baseline.

This was a cluster-randomised trial and authors stated they did not make allowance for clustering in the sample size calculation as the cluster effect was expected to be small. Elsewhere in the paper an ICC value was provided, which the authors said indicated that cluster effect was small. It was not clear that the cluster design effect was taken into account in any of the analyses.

Labarere 2005

Methods2-arm RCT, with individual randomisation, recruitment October 2001-May 2002, n = 231
Participants

Setting: the maternity section at the Chambery Teaching hospital in Chambery, France

Background rates of breastfeeding initiation: intermediate. Breastfeeding prevalence rates were 70.8% in hospital and 58.1% at 1 month of infant age.

Inclusion criteria: mothers of healthy singleton infants (gestational age: > 37 completed weeks), breastfeeding on the day of discharge and consenting to participate in the study.

Exclusion criteria: infants admitted to neonatal unit, mothers transferred to ICU, mothers < 18 years old, living outside the area, unable to speak French, or unable to complete follow-up monitoring because of psychosocial problems such as homelessness

Participant characteristics:

Age: mean (SD): intervention: 29.3 years (4.1); control: 29.7 years (4.8)

Education beyond high school graduate level: intervention: 87 (75.0); control 84 (73.0)

White collar worker: intervention: 92 (79.3); control 87 (75.6)

Primiparous: intervention: 58 (50.0); control: 63 (54.8)

Interventions

Intervention (n = 116): in addition to standard care, mothers were invited to an outpatient visit in a primary care physician’s office within 2 weeks of the birth to see a primary care doctor who had received special breastfeeding education. Topics covered included general health assessment, lactation physiology, feeding position and latch on assessment, management of common lactation problems (nipple pain, nipple cracks, sore nipples, mastitis, and maternal concern regarding low milk supply), management of infant problems (insufficient weight gain, breastfeeding jaundice, diarrhoea and dehydration), maternal medication use while breastfeeding and sources of support. The physicians' training programme was delivered through lectures, panel discussions, role playing exercises and printed educational materials.

Control (n = 115): standard care; mothers received verbal encouragement from maternity ward staff to maintain breastfeeding. On discharge, the infant was examined by the paediatrician working in the department, for a general health assessment and an evaluation for evidence of successful breastfeeding behaviour. The mothers were also provided with the telephone number of a peer support group that they could call to ask questions and request help. The postdischarge follow-up monitoring consisted of routine, preventive, outpatient visits in a primary care physician’s office at 1, 2, 3, 4, 5 and 6 months of infant age.

Outcomes

Primary: exclusive breastfeeding at 4 weeks (exclusive breastfeeding defined as giving maternal milk as the only food source, with no other liquids or foods)

Secondary: any breastfeeding at 4 weeks, median duration of breastfeeding, breastfeeding difficulties and maternal satisfaction with the infant feeding experience

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskThe allocation sequence was generated by the statistical adviser of the study with random permuted blocks with a block size of 8.
Allocation concealment (selection bias)Low riskThe randomisation assignments were unknown to any of the investigators and were concealed in consecutively numbered, sealed, opaque envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding of participants or personnel
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcomes were assessed using self-completed questionnaires, however, it was not stated whether the investigators analysing the data were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk(1080 women assessed for eligibility, 849 deemed not eligible) 231 women randomized, outcome data were available for all but 5 of the woman randomized, and a sensitivity analysis was carried out where the most conservative values were assumed for those women lost to follow-up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not judge this
Other biasUnclear riskThe majority of women assessed were not eligible for inclusion in this trial and so the results may not be generalisable.

Laliberte 2016

Methods2-arm, RCT, single site, n = 472
Participants

Ottawa, Canada

Background breastfeeding rates: not stated

Inclusion criteria: women ≥ 18 years, with no diagnosed medical problems, with a healthy singleton infant at a gestational age of over 36 weeks and 6 days who were breastfeeding their baby and intended to continue upon discharge, and could be contacted by phone or email after hospital discharge

Exclusion criteria: women who did not speak English or French, were unable to present to the clinic (transport not available), with multiple, preterm or adopted babies, with no plan or desire to breastfeed, women who had had breast surgery or a psychological risk that might impede their ability to attend the first appointment at the clinic. Out-of-province women were also excluded given the geographic distance and difference in social services.

Interventions

Intervention (n = 315): within 48 h of discharge, women attended the postpartum clinic. Clinic staff followed up with participants if they failed to keep the mandatory follow-up appointment. The first appointment included maternal assessment and care (e.g. wound care, prescriptions), neonatal care (e.g. weight gain assessment, jaundice screening), blood work including total serum bilirubin (TSB), and breastfeeding assessment and support. Family physicians were available for on-site consultations in the mornings, and LCs and registered nurses were at the clinic throughout the day. Additional follow-up visits were offered to participants as clinically indicated and as many times as they desired up to a maximum of 6 weeks following the birth of their baby.

Control (n= 157): after hospital discharge, participants were entitled to receive follow-up care and seek breastfeeding support currently available in the community (e.g. through their family doctor, Public Health Unit or private services), but could not attend the postpartum clinic.

Outcomes

Primary: exclusive breastfeeding at 12 weeks postbirth (additional breastfeeding information regarding partial breastfeeding, expressed breast milk and formula feeding was also collected)

Secondary:

Mother Satisfaction Survey

Breastfeeding self-efficacy

Postpartum depression

Use of healthcare resources

NotesAll phases of this study were supported by the Ontario Ministry of Health and Long-Term Care.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskGroup designation was given from a randomisation list, generated using a permuted randomized block design, with permutation block sizes of 3, 6, and 9 units, prior to study initiation by an external statistician.
Allocation concealment (selection bias)Low riskStudy researchers, recruiters, and participants were blinded to the randomisation allocations prior to patient randomisation and enrolment into the trial.
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen were informed of their randomisation group. Clinicans were also aware of group allocation.
Blinding of outcome assessment (detection bias)
All outcomes
High riskStudy staff were not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition to 6 months was 14% in the intervention group and 12% in control group.
Selective reporting (reporting bias)High riskBreastfeeding at 24 weeks is not identified as an outcome in the paper or the protocol, but was reported in table 4.
Other biasLow risk 

Leite 2005

Methods2-arm RCT, with individual randomisation, n = 1003. Participants recruited from 8 public health maternity units, duration of recruitment 6 months
Participants

Urban Brazil

Background rates of breastfeeding initiation: high

Inclusion criteria: healthy babies, weighing < 3000 g

Exclusion criteria: twins, important health problems in mother or child

InterventionsPeer counsellor home visits lasting 30-40 min at 5, 15, 30, 60, 90 and 120 days. Counsellors were from same social group as women they supported, had personal experience of breastfeeding and had been associated with maternity unit milk bank for a minimum of 5 years. Trained with adapted WHO breastfeeding counselling course (20 h). Paid BRL4 per visit. Each counsellor supported 25 mothers.
OutcomesRates of exclusive, predominant, partial and artificial feeding at 4 months
NotesThis is the only study in this review that targeted babies with birthweight below 3000 g. We considered excluding it from this review as the paper did not state the babies had to be born at term and did not specify a lower limit for birthweight. However as the babies had to be 'free of important health problems' we considered them to be healthy and therefore included this study.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random number table
Allocation concealment (selection bias)Low riskStudy secretary opened a sealed envelope that contained the study code.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDid not describe whether mothers, lay workers or health professionals were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAuthors state that the "interviewers had not had any prior contact with the mothers and were also unaware as to the objectives of the research (blinding)".
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk1003 women randomized. 14% lost to follow-up by the end of 4 months. Reasons for loss to follow-up were not described but the loss appeared balanced across the 2 groups.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasLow riskNo baseline imbalance apparent.

Lucchini 2013

MethodsParallel 2-arm RCT, single site, n = 770
Participants

Maternity ward at the Sotero del Rio Hospital, Santiago, Chile. Programme delivered by South East Metropolitan Health Service in conjunction with the Catholic University of Chile.

Background breastfeeding initiation rates: on this ward 79.4% of the live births were fed with exclusive breastfeeding (EBF) up to 1 month of age and 67.3% were fed in this manner until 3 months of age. This was similar to national figures.

Inclusion criteria: pregnancy without illness or risk factors which required more intensive maternal and/or perinatal monitoring during the process of labour and delivery, spontaneous initiation of labour , gestational age between 37 + 0 and 41 + 0 weeks, single pregnancy, live fetus and cephalic presentation

Exclusion criteria: women with illnesses or risk factors that required more intensive maternal and/or perinatal monitoring

Interventions

Intervention (n = 384): 'comprehensive care' consisting of family member who accompanied the woman from admission to discharge, 24 h/day, and who participated actively throughout the period. Labour took place in a comprehensive room with constant care, with early skin-to-skin contact of at least 1 h and encouragement of early initiation of breastfeeding (positive covariates for EBF). During the immediate postpartum period personalised educational support was delivered by the healthcare team. Early discharge with comprehensive intervention (after 24 h) was complemented by a home visit (after 48 h) where the mother's and baby’s care was reinforced, as well as the breastfeeding technique in a family setting.

Control (n = 386): 'traditional care', i.e. standard care from the public health system. This involved labour management interventions (negative covariates for EBF) with intermittent and passive family participation. Early skin-to-skin contact was performed without any standardised guidelines and mother and child room-sharing began once the newborn had received immediate care. During the postpartum period, professional and technical support was given for the start of breastfeeding in the postnatal unit.

OutcomesPrevalence of exclusive breastfeeding at 8, 16 and 24 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskThe pregnant women were assigned randomly to both forms of intervention, using a randomized block design of 6-8 women, so that in each block an equal number of women were assigned to each group but not clear how sequence was generated.
Allocation concealment (selection bias)Unclear riskNo details provided to enable us to judge this.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDid not state whether women or staff providing intervention were blinded, but unlikely.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was not stated whether the data collectors were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low riskFollow-up was 85.9% in the intervention group and 82.6% in the control group. There were no significant differences between the women lost to follow-up and those who remained in the study. The number of cases lost to follow-up (15.7%) was mainly due to a change of telephone number and address (Figure 1) For this reason it was expected that those lost to follow-up were 'missing at random'.
Selective reporting (reporting bias)Unclear riskNo protocol or document with predefined outcomes available. This paper focused on data collected at 8 weeks. Data collected at 16 and 24 weeks were not reported and no explanation was given.
Other biasHigh riskIntervention contained other components which may influence breastfeeding, including 24-h family participation during hospital stay and these different birth experiences are also important.

Lynch 1986

Methods2-arm RCT, with individual randomisation, single-site study, duration of recruitment not stated, n = 270
Participants

Urban Canada - maternity unit of regional general hospital

Background rates of breastfeeding initiation: intermediate. Baseline prevalence (1984) = 69% breastfeeding initiation (75% stopping by 6 months)

Inclusion criteria: intending to breastfeed; English-speaking

Exclusion criteria: multiple births; birthweight < 2500 g; birth before 37 weeks

Participant characteristics:

41% were primiparous; ethnic composition not described; socioeconomic status defined by Blishen scale for husband's occupation (62% groups 2-3)

Interventions

Intervention: combination of home visit by breastfeeding consultant within 5 days of hospital discharge (duration 2 h) and weekly telephone calls by the consultant for 1 month, then monthly from 2-6 months

Control: postpartum home visit by public health nurse who gave breastfeeding advice determined largely by the questions and concerns of the mother

OutcomesDuration of breastfeeding
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described "we randomly allocated 270 new mothers".
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskIt was not stated whether the women, public health nurses or LCs were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe interviewer conducting the questionnaire was not aware of the study group status.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere appeared to be little loss to follow-up; 270 women were randomized and questionnaire data were acquired from 256 (5% attrition); 3 women were lost from the intervention group vs 11 from the control group.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskLittle information about the methods. Possible confounders included: significant differences in baseline characteristics for parity (P = 0.02) and intention to return to work (P = 0.05).

McDonald 2010

Methods2-arm RCT, recruitment March 2000-October 2001 n=849
Participants

Large university teaching hospital in Victoria, Australia

Background rates of breastfeeding initiation: high. Baseline prevalence of breastfeeding in Australia = 83% at hospital discharge

Participants were women intending to breastfeed their term infants, and were stratified by tertiary education and parity

Interventions

Intervention (n = 425): Extended Midwifery Support (EMS); women received an in-hospital postnatal education session. Postdischarge, they were offered home support visits with a research midwife once a week and telephone contact at least twice a week for 6 weeks

Control (n = 424): Standard Midwifery Support (SMS); women received routine midwifery support and information according to the hospital protocol. The study hospital was working towards Baby-Friendly accreditation during data collection (achieved in 2004)

OutcomesAny breastfeeding and exclusive breastfeeding at 6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskSample stratified by educational level and parity. Methods not clear.
Allocation concealment (selection bias)Unclear riskPaper stated "Women were asked to select an envelope from a group of at least 6 sealed, opaque envelopes, replenished in blocks of 12. The envelopes contained the allocation to either the intervention or control group".
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo detail provided on blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo detail provided on data collection so judgement not possible.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk849 women randomized. Loss to follow-up was reported by group at 2 months (intervention 83/425, 19.5% vs control 124/424, 29.2%) and at 6 months (intervention 8/425, 1.9% vs. control 4/424, 0.9%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskAbstract did not include details of allocation concealment, outcome assessment or loss to follow-up. Outcomes included in the abstract were reported by ITT.

McKeever 2002

Methods2-arm RCT, individual randomisation, n = 101
Participants

Setting: study carried out in Canada

Inclusion criteria: live, singleton, term or near term infant delivered in 12 h before recruitment; women ≥ 21 years residing in defined study area, intending to breastfeed and with satisfactory home circumstances (assessed by postpartum nurses)

Exclusions: non-English-speaking women, caesarean delivery, postpartum complications, infants with congenital abnormalities or morbidity

Interventions

Intervention: planned early discharge from hospital (24 h-36 h postpartum) and up to 3 home visits by community nurse LCs. Content of support unclear. The study aimed to compare of breastfeeding support in home and hospital settings.

Control: planned hospital discharge 48 h-60 h postpartum (usual care) with hospital based support for breastfeeding

OutcomesExclusive breastfeeding at 5-10 days postpartum and satisfaction with care
NotesWe have not included data from this study in the review. Outcomes were not assessed at the same time in the intervention and control groups (mean day of follow-up was 8.4 days in the intervention group vs 7.8 days for controls) and there was high attrition (26% overall, with 33% loss to follow-up in the control group).
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCentral randomisation
Allocation concealment (selection bias)Low riskCentral randomisation by staff not concerned with the study.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "Blinding was not possible for the mothers or nurses as the experimental treatment (i.e. discharge to the home-based lactation support) was known."
Blinding of outcome assessment (detection bias)
All outcomes
High riskQuote: "Interviewers were originally blinded to group status. However, in the course of answering questions about postpartum care and satisfaction, mothers inadvertently revealed their group status."
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOutcomes were not assessed at the same time in both groups and there was high attrition (26% overall, with 33% loss to follow-up in the control group).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskQuote: "At baseline, no differences in maternal age, parity or gestational age were found in the two groups."

McLachlan 2016

Methods3-arm cluster-controlled trial, single site, n = 9675
Participants

Local government authorities (LGA) in Victoria, Australia - community-based maternal and child health centres

Background rates of breastfeeding initiation: only rates at 6 months detailed. Ranged from 32% to 68% in different LGAs in Victoria.

Inclusion criteria: LGAs in Victoria with a lower rate of any breastfeeding at discharge from hospital than the Victorian state average; and > 450 births per year. For the postal survey women were recruited on the basis of giving birth during the intervention time-frame in all participating LGAs.

Exclusion criteria: LGAs with breastfeeding initiatives in place similar to the proposed interventions. Women living in participating LGAs were not sent an invitation to take part in th postal survey if it was known that either they or the infant died, they had moved to another LGA since the birth or they were not enrolled in the Maternal and Child Health Service.

Interventions

Intervention 1 (n = 3335): home visiting only (HV) - early home-based visiting by a maternal and child health nurse (MCHN) to women identified at risk of breastfeeding cessation. Aimed to provide proactive breastfeeding assistance as early as possible after birth. The focus of the visits were was the normalisation of breastfeeding, building women’s confidence to breastfeed, reassurance, development of an infant feeding plan (where needed), and provision of a list of useful web sites and telephone numbers. The topics covered at individual visits were driven by the specific needs of the woman.

Intervention 2 (n = 2891): HV + access to a drop-in centre - women received home visit service as above and could attend local community breastfeeding drop-in centre staffed by a MCHN, and where possible with a trained peer supporter or community educator or counsellor. Also provided mothers with the opportunity to meet and learn from other mothers. The centre was widely advertised.

Control (n=3449): Usual care. Midwife visit 1-2 days after discharge and then MCHN visit 10-12 days after discharge (breastfeeding assessment, support and advice a core component of care). Then MCH centre based care thereafter.

Outcomes

Primary: any breastfeeding at 4 months

Secondary: any breastfeeding at 3 and 6 months

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskEnvelopes shuffled
Allocation concealment (selection bias)Low riskAllocation to trial arms took place using opaque envelopes at a state-wide MCH forum.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBlinding "was not possible at the LGA (randomisation) or cluster levels; however, individual women in the LGAs were not aware of the intervention allocation—the intention was that any trial arm allocation was ‘standard’ care within the LGA during the intervention period". However it is not clear if this was successful and whether staff were blinded or not.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome assessment by participant-completed questionnaire sent by mail, but not stated if those analysing the data were blinded to allocation.
Incomplete outcome data (attrition bias)
All outcomes
High riskHigh loss to follow-up at 4 months in control group (69% of women followed-up) and home visiting group (68% of women followed up), Follow-up was higher in home visiting plus group, with 81% of women followed up.
Selective reporting (reporting bias)Low riskNot all secondary outcomes listed in protocol were reported, but these were not outcomes of interest in this review so we marked this trial as being at low risk of bias.
Other biasUnclear riskSignificant differences in proportion of Australian-born women in across the groups (69% in comparison LGAs; 58% in home-visiting LGAs; 73% in home-visiting plus drop-in centre LGAs). Unclear whether this could have an impact.

McQueen 2009

Methods2-arm RCT, single site, n = 150
Participants

Conducted at a tertiary care centre located in Northwestern Ontario, Canada.

Background breastfeeding initiation rates: 87.3%

Inclusion criteria: English-speaking, primiparous mothers who gave birth to a single, healthy, term infant whom they were planning on breastfeeding

Exclusion criteria: any condition that could significantly interfere with breastfeeding, such as a serious illness, an infant with a congenital anomaly, or requiring special care that would not be discharged home with the mother

Interventions

Intervention (n = 69): participants received 3 individualized, self-efficacy enhancing sessions with the researcher: 2 in-hospital and 1 by telephone in the early postpartum period. The first session occurred after randomisation and within 24 h of delivery. The second session also took place in-hospital, ideally within 24 h of the first session. In addition, observation of breastfeeding at 1 of the 2 in-hospital sessions was planned to try to maximize performance accomplishment (successful breastfeeding). The third session occurred via telephone within 1 week of hospital discharge.

Control (n = 81): standard in-hospital and community care

Outcomes

Primary: feasibility, compliance, and the acceptability of the breastfeeding self-efficacy intervention

Secondary: breastfeeding self-efficacy, duration, and exclusivity

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation was achieved using consecutively numbered, sealed opaque envelopes containing group allocations generated by an experienced researcher not involved in the trial.
Allocation concealment (selection bias)Low riskRandomisation was achieved using consecutively numbered, sealed opaque envelopes containing group allocations generated by an experienced researcher not involved in the trial.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding was not possible.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskMothers were telephoned by a research assistant who was blinded to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition in intervention group was 11.5% and 13.6% in the control group.
Selective reporting (reporting bias)Unclear riskNo trial registration document with prespecified outcomes.
Other biasLow riskNone identified

McQueen 2011

MethodsPilot RCT (n = 150), March-July 2008
Participants

Recruitment from 1 hospital in Northwestern Ontario, Canada, the sole provider of maternity care for the city and regional referral centre

Background rates of breastfeeding initiation for Canada: intermediate, however, baseline prevalence of 'ever breastfed' in Ontario 90.6% (WHO Global Data Bank on Infant and Young Child Feeding accessed 12 Oct 2011)

Inclusion criteria: English-speaking, primiparous, planning on breastfeeding, with single, healthy, term infants

Exclusion criteria: conditions that could significantly interfere with breastfeeding such as serious illness, infant with congenital anomaly or admitted to special care

Interventions

Intervention: standard in-hospital and community postpartum care plus a 1-to-1 self-efficacy intervention from the researcher (a Registered Nurse with practice, education, and research experience working with breastfeeding mothers). The intervention included assessment of the mother’s breastfeeding goals and breastfeeding self-efficacy and her general physiologic and affective state; strategies to increase breastfeeding self-efficacy; evaluation, and planning the next session. There were 3 contacts, 2 face-to-face in hospital on days 1 and 2 after the birth, and 1 phone call up to 7 days after hospital discharge.

Control: standard in-hospital and community postpartum care, which included a visit by a public health nurse after hospital discharge

OutcomesFeasibility, compliance, and acceptability of the intervention, breastfeeding confidence (self-efficacy scores), any and exclusive breastfeeding at 4 and 8 weeks
NotesPaper stated "Observation of breastfeeding at 1 of the 2 in-hospital sessions was planned, to try to maximise performance accomplishment (successful breastfeeding)”.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskGroup allocations generated by an experienced researcher not involved in the trial.
Allocation concealment (selection bias)Low riskConsecutively numbered, sealed opaque envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and the caregivers were not blinded due to the nature of the intervention.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcomes at 4 and 8 weeks postpartum were collected during phone interview by research assistant reported to be blind to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low riskOutcomes measured at 8 weeks in 134/150  (89%). Loss to follow-up was balanced across groups. For breastfeeding outcomes we have carried out an ITT analysis.
Selective reporting (reporting bias)Unclear riskNo baseline differences between groups apparent.
Other biasUnclear riskBaseline characteristics were similar.

Mejdoubi 2014

Methods2-arm parallel RCT, single site study, n = 460
Participants

20 municipalities in the Netherlands, demographics not described

Background rates of breastfeeding initiation: not described

Inclusion criteria: ≤ 25 years, low educational level (primary school or prevocational secondary school), maximum 28 weeks of gestation, no previous live birth, understood Dutch, and at least 1 of the following additional risk factors: no social support, previously or currently experiencing domestic violence, psychosocial symptoms, unwanted and/or unplanned pregnancy, financial problems, housing difficulties, no education and/or employment and alcohol and/or drug use

Exclusion criteria: previous live births, no additional risk factor as detailed above

Interventions

Intervention (n = 237): the VoorZorg programme - a home visitation programme translated and culturally adapted from the Nurse Family Partnership (NFP) programme. In addition to usual care, women received approximately 10 home visits during pregnancy, 20 during the first life year of the child and 20 during the second by trained, specialised VoorZorg nurses. 6 domains were discussed during the home visits: 1) the health status of the mother, 2) the child's health and safety, 3) the personal development of the mother, 4) the role of the mother, 5) the mother's relation with her partner, family and friends, and 6) the use of (health) care organizations. During pregnancy, women receiving the VoorZorg intervention were encouraged to initiate and continue breastfeeding after childbirth. The VoorZorg nurse also discussed the problems women encountered when breastfeeding their child and worked together with the mother to seek solutions to continue breastfeeding. The VoorZorg nurses also aimed to reduce smoking with the V-MIS smoking cessation programme.

Control (n = 223): usual care provided by the Dutch Youth Health Care Organizations. Every pregnant women received care by a midwife including health education, physical examination and monitoring fetal development. The baby was automatically registered at an ambulatory well baby clinic for monitoring after birth and the parents were supported in parenthood.

Outcomes

Primary:

Prevalence of cigarette smoking (percentage of smokers and average number of cigarettes smoked a day)

Average number of cigarettes smoked a day near the baby

Birthweight

Weeks of gestation

Adverse pregnancy outcome (LBW, prematurity)

Breastfeeding initiation

Breastfeeding at 6 months

Secondary:

Any breastfeeding at 3 and 6 months

NotesThe Netherlands Organisation for Health Research and Development (ZonMw), Academic Collaborative Centre, Child Health Care-North HollandVU University Medical Center, participating Youth Health Care organizations and ZonMw Geestkracht, and participating city councils provided funding for the implementation of this study
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated list of random numbers
Allocation concealment (selection bias)Unclear riskIndependent randomisation procedure performed by a researcher at VU university
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and staff were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe interviewers were blinded regarding allocation but this may have been disclosed during interview
Incomplete outcome data (attrition bias)
All outcomes
Low riskLoss to follow-up in control group was 18% and 8.4% in intervention group; authors stated baseline characteristics of women who were lost to follow-up in each measurement were similar to women who remained in the study.
Selective reporting (reporting bias)Low riskProtocol included domestic violence, child development and child abuse as primary outcomes, but these were not reported in the results section. Breastfeeding was not reported as an outcome in the protocol, but was included as a primary outcome in the results paper. Authors stated that prevalence of babies with low birthweight, being premature or being small for gestational age, was similar in both groups.
Other biasLow riskNone identified

Mongeon 1995

MethodsQuasi-RCT (drawing numbered tickets), single site, duration of recruitment not stated, n = 200, follow-up 97%
Participants

Urban Canada

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: women who wished to breastfeed and who had not previously breastfed

Participant characteristics:

97% primiparous, ethnic composition not stated, 57% had received education to college or university level, no specific socioeconomic classification used

Interventions

Intervention: home visit by volunteer during last month of pregnancy followed by telephone contacts weekly for 6 weeks and then 2 weekly to 5 months or until weaning. Volunteers were women who had breastfed themselves and had received 3 training sessions of 3 h duration followed by on-going monthly supervision sessions. Average caseload was 1-3 cases at any 1 time.

Control: received home visit from public health nurse during the first month after birth followed by other contacts (face-to-face or by telephone) as determined by the mother

OutcomesBreastfeeding rates at 1, 2, 3, 4 and 6 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomisation by "drawing numbered papers"
Allocation concealment (selection bias)Unclear riskNot clear
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskArticle in French, unable to judge blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThere was an attempt to blind outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskReasons for drop-out recorded; 200 randomized, 3 babies died and 3 other women lost to follow-up
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this
Other biasUnclear riskNot clear over what time period women were recruited or whether controls and intervention women were recruited at the same time. Quote: "Subjects were recruited during various periods of time, depending on the availability of volunteers"

Morrell 2000

Methods2-arm RCT, individual randomisation, single-site study recruiting over 14 months, n = 632
Participants

Urban UK

Background rates of breastfeeding initiation: intermediate. National baseline prevalence 66% breastfeeding at birth and 42% at 4 months. Exclusive breastfeeding 21% at 4 months.

Inclusion criteria: English-speaking women, ≥ 17 years, who gave birth at the study hospital

Exclusion criteria: baby spent > 48 h on the SCBU

Interventions

Intervention: community postnatal support worker with 8 weeks' training provided home-based support of up to 10 visits in the first 28 days (maximum of 3 h/visit)

Control: standard UK care (includes postnatal home visits from midwives and health visitors)

OutcomesExclusive or any breastfeeding at 6 weeks and 6 months
Notes

Study population not limited to those intending to breastfeed

Women consenting to participation more likely to be white and have had a CS

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number tables
Allocation concealment (selection bias)Low riskSequentially numbered sealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details provided about blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details provided about blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk623 women randomized; stated that analysis was by ITT; 30 women who declined visits were included in the analysis; 78% follow-up
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskThere was some baseline imbalance between groups. Women in the intervention group were more likely to have twins (9 vs 1), to have another adult resident in their household and to have used TENS in labour.

Morrow 1999

MethodsCommunity-based cluster-randomised study; recruitment over 18 months, n = 130
Participants

Peri-urban Mexican community

Background rates of breastfeeding initiation: high

All pregnant or postnatal women were in 39 geographical clusters. Perinatal death only clinical exclusion criterion. Baseline breastfeeding prevalence: 92% initiation; 4% exclusivity at 2 weeks and 3 months; 50% cessation by 6 months

Interventions

Home visits were conducted by peer-counsellors trained by La Leche League (7 days theoretical teaching/2 months in lactation clinics and with mother-to-mother support groups), personal breastfeeding experience was not essential.

Intervention 1: 6 visits (mid and late pregnancy and at 1, 2, 4 and 8 weeks)

Intervention 2: 3 visits (late pregnancy and 1 and 2 weeks)

Control: not specified

Outcomes

Breastfeeding at 3 and 6 months

Incidence of diarrhoea in infants 0-3 months

NotesSubgroup analysis: antenatal and postpartum support; proactive intervention with scheduled contacts at home; initial face-to-face contact; intervention delivered by trained counsellors
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskCluster-randomisation, clusters stratified by area, randomisation schedule generated by computer.
Allocation concealment (selection bias)Low riskClusters randomized by computer.
Blinding of participants and personnel (performance bias)
All outcomes
High riskClusters randomized to avoid contamination, but women and counsellors would have been aware of intervention.
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome measurement was by staff who were aware of group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk130 women from 31 cluster areas randomized; 125 followed up at 3 months and 104 at 6 months (20% attrition at 6 months).
Selective reporting (reporting bias)Unclear riskHow cluster design was taken into account was not clear. It was stated that ICC values were 'negligible' and the authors stated "these results show that the cluster-randomisation design achieved the equivalent of individual randomisation".
Other biasUnclear riskNo baseline imbalance apparent, although group size was uneven (this may have been due to chance).

Muirhead 2006

Methods2-arm RCT, with individual randomisation, n = 225
Participants

Setting: general practice in Ayrshire, Scotland

Background rates of breastfeeding initiation: low
Inclusion criteria: women at 28 weeks' gestation attending for antenatal care at a GP practice
Exclusion criteria: not described

Participant characteristics:

Mean age of intervention group: 28.5 years; SD 5.2; range 17-43. Mean age of control group: 27.8 years; SD 5.5; range 16-40

Parity: 53% primiparous

Interventions

Intervention (n = 112): women were assigned 2 peer supporters (women with previous breastfeeding experience) who contacted them at least once in the antenatal period and provided further antenatal support on request. In the postnatal period after hospital discharge peer supporters contacted women who were still breastfeeding at least every 2 days by phone or by home visit up until 28 days, and further support was available up to 16 weeks postpartum.

Control (n = 113): standard care that included visits from community midwife for the first 10 days, health visitor after 10 days; breastfeeding support groups and breastfeeding workshops were available.

OutcomesInitiation of breastfeeding, any and exclusive breastfeeding at 6 weeks and 6 months, median breastfeeding duration and reasons for giving up breastfeeding
NotesThe researchers noted that "health professionals varied in their commitment to breastfeeding and also in their acceptance of lay assistance, such as peer support".
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskAllocation sequences for each stratum (primagravidae, previous formula feeding, previously breastfed < 6 weeks, previously breastfed > 6 weeks) were generated at the start of the trial by computer in blocks of 10 (that is, 5 random allocations to each of the peer support and control groups in each different block of 10) to give approximate numerical balance between groups.
Allocation concealment (selection bias)Low riskAllocation to control or peer support group was by post-recruitment concealed allocation, with a telephone call for the next allocation on the list.
Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "There was no post-allocation concealment as once a woman was allocated to the peer support or control group this was known to the peer supporters and others associated with the trial.”
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThe questionnaire were completed in the presence of a GP or practice nurse. It is also stated that trial team were not involved in the questionnaire completion. Unclear if the GP or practice nurse would have been aware of group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

Low loss to follow-up.

Peer support group (intervention group) (n = 112): at 16 week follow-up, n = 110; control group (n = 113): at 16 week follow-up, n = 110

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear risk

Planned recruitment was for 320 women but ended after 225 women recruited, therefore the study had reduced power to detect differences between groups.

Few demographic data were reported so it was not clear whether or not there was baseline imbalance, although recruitment was balanced for parity by stratification.

Ochola 2013

Methods3-arm cluster-controlled trial, single-site study, n = 360 (note only 2 arms included in analysis)
Participants

Kiberia slum, Nairobi, Kenya - a densely populated area that was not well served with basic services such as health facilities, adequate safe water and sanitation services.

Background rates of breastfeeding initiation: no data on initiation, but for Kenya the exclusive breastfeeding rate for infants under 6 months was 32.0%.

Inclusion criteria: in the third trimester of pregnancy (34–36 weeks’ gestation), HIV-negative, intention to stay in Kibera for at least 6 months after delivery, willing to be visited at home, willing to be included in the study

Exclusion criteria: documented chronic diseases such as diabetes mellitus, renal disease, heart disease or any other chronic disease, and eclampsia in a previous pregnancy

Interventions

Intervention 1 (n = 120): home-based intensive counselling group (HBICG); mothers received 7 counselling sessions: prenatally, the first week after delivery and then monthly up to 5 months postpartum. The content was similar to the facility-based semi-intensive counselling group (FBSICG; see Intervention 2) but was more tailored to the mother’s needs and more detailed. Women also had more practical exposure with regard to supporting breastfeeding (e.g. positioning, attachment, expression of milk). Counsellor training was the same as for FBSICG.

Intervention 2 (n = 120): FBSICG; note this intervention was an antenatal one only, so not included in this review). Consisted of 1 session of 1-to-1 counselling at the health centre conducted by the investigator and breastfeeding counsellors. The breastfeeding counsellors were 3 local women trained in accordance with the WHO/UNICEF counselling course (40 h). The counselling content was structured around the benefits of exclusive breastfeeding; preparation for breastfeeding initiation and sustainability of breastfeeding; positioning and attachment of baby to the breast during feeding; and prevention and management of breastfeeding challenges. The single session took place after enrolment into the study..

Control (n = 120): usual standard health and nutrition education offered at the health centre. This was a group-based education programme which covered breastfeeding and a range of other topics.

Outcomes

Primary: exclusive breastfeeding at 1, 3 and 6 months

Secondary: cumulative (since birth exclusive breastfeeding at 6 months).

NotesFunded by Nestle.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated using Excel for randomisation of the clusters.
Allocation concealment (selection bias)Low riskMethod of concealment not described.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskPaper stated that only the investigator and peer counsellors were aware of the treatment given and knew the hypothesis. The nurse in charge was blinded to the intervention allocation. It was not clear if the women were aware of the allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe enumerators conducting the interviews to determine breastfeeding practices were blinded to the study hypotheses to avoid any likelihood of bias in the way they asked questions, even though they were trained to ask questions in a standard way. There was no contact between the enumerators and the breastfeeding counsellors.
Incomplete outcome data (attrition bias)
All outcomes
High riskFollow-up in both intervention and control groups was 74.2%. The analysis was as-treated and not ITT. Younger women were significantly more likely to be lost to follow-up.
Selective reporting (reporting bias)Unclear riskNo evidence of a study protocol to judge whether all predefined outcomes were assessed.
Other biasUnclear riskFunded by Nestle.

Paul 2012

Methods2-arm RCT, n = 1154
Participants

Pennsylvania, USA

Background rates of breastfeeding initiation: no details provided

Inclusion criteria: singletons and twins born after at least 34 weeks’ gestation to English-speaking mothers attempting to breastfeed during the maternity stay and with intent to continue breastfeeding after discharge

Exclusion criteria: atypical stays characterised by: 1) a 2-night or longer stay after a vaginal delivery; 2) a 4-night stay or longer after a cesarean section; 3) a hospital course with atypical complications (e.g. ambiguous genitalia, endometritis); or 4) newborn hyperbilirubinemia requiring phototherapy during the nursery stay. Mothers were also excluded for major morbidities and/or pre-existing conditions that would affect postpartum care, lack of a telephone number, previous study participation, residence outside the coverage region of the Visiting Nurse Association of Central Pennsylvania (VNA), or if a home nursing visit was specifically requested by a hospital social worker or child protective services owing to social concerns.

Interventions

Intervention (n = 576): 1 home nursing visit within 48 h of hospital discharge (typically 3-5 days post birth). All nurses received continuing education related to breastfeeding support and cultural competency prior to study initiation. All newborns in intervention group were scheduled for an office-based visit 1 week after the visit to assess weight and recovery.

Control (n = 578): office-base care; postdischarge visit timing for newborns was determined by the newborn nursery physician

Outcomes

Primary: maternal and infant use of unplanned health care services in the 14 days after delivery

Secondary:

Breastfeeding duration and exclusivity

Maternal postpartum depression

State of anxiety

Percieved social support

Parenting self-efficacy

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence
Allocation concealment (selection bias)Unclear riskNo information provided about allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot detailed whether mothers and/or home visiting nurses were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskTelephone interviews with mothers conducted by study co-ordinators blinded to study group.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk8% attrition by 2-week telephone interview; 13% attrition at 2-month telephone interview. However, at 6 months attrition was 31% in the home nursing visit group and 38% in the office-based care group.
Selective reporting (reporting bias)Unclear riskOutcomes not stated in Clinicaltrials.gov record. Unclear whether ‘any breastfeeding’ or ‘exclusive breastfeeding’ were reported, but both should have been, however, additional information received from author included both.
Other biasLow risk 

Petrova 2009

Methods2-arm RCT, with individual randomisation, n = 104
Participants

Setting: maternal and paediatric clinic for low-income inner-city population (New Jersey, USA)

Background rates of breastfeeding initiation in this population: high

Inclusion criteria: WIC program-qualified pregnant women in the third trimester of a singleton pregnancy without HIV, cancer, or illegal drug use

Participant characteristics: 87.5% of the women were of Hispanic origin, 89% spoke Spanish at home, 30% were single, approximately 70% were educated to less than high school level. 37% of the intervention group, compared with 42% of controls, were expecting their first child.

Interventions

Intervention (n = 52): in addition to routine care, allocated to 2 individual educational/support sessions with a LC in the third trimester of pregnancy lasting 15-20 min. After birth the LC provided support at the hospital or by phone soon after discharge, with further phone support after the first or second week then after 1 and 2 months. The participants were asked to contact the LC if they experienced any breastfeeding problems.

Control (n = 52): routine breastfeeding education and support during the pregnancy and postpartum. LC services were available for all postpartum women if any breastfeeding problems arose during the hospital stay.

OutcomesExclusive and any breastfeeding at 7 days and 1, 2  and 3 months postpartum
NotesAmong multiparous participants, 27/29 (93%) in the intervention group had previously breastfed, compared with 17/25 (68%) in the control group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: “We used computer generated random numbers to assign women to the control and intervention groups. Each random number was related to an ordinal number that was assigned to the woman once she assigned the informed consent."
Allocation concealment (selection bias)Unclear riskNot described.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details provided to enable a judgement.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details provided to enable a judgement.
Incomplete outcome data (attrition bias)
All outcomes
High risk

104 women randomized. 82% available to follow-up at 1 month (data included in the review) 70% of women followed up for 3 months (35/52 in intervention group completed the 3-month follow-up (loss of 17); 38/52 in the control group completed the 3-month follow-up (loss of 14)).

High attrition, but reasons for loss were given and balanced across groups (e.g. phone disconnected; women did not answer phone; some women did not notify the research team about their delivery).

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskThere was some baseline imbalance between groups that meant that differences between groups were difficult to interpret. Of the multiparous women 93% in the intervention group had previous breastfeeding experience compared with 68% in the control group. More women in the control group had a CS (40% vs 14%).  Both of these differences possibly relate to breastfeeding outcomes.

Porteous 2000

Methods2-arm RCT with individual randomisation, single-site study, recruiting over 3 months, n = 52
Participants

Urban Canada

Background rates of breastfeeding initiation: intermediate

Baseline breastfeeding prevalence at 4 months: approximately 33%

Inclusion criteria: singleton pregnancy, healthy mother and child, vaginal delivery, self-identified on breastfeeding questionnaire as unsupported

Interventions

Intervention: breastfeeding support from the researcher, a community midwife, consisting of daily visits in hospital, telephone call within 72 h of discharge and weekly through the fourth week postpartum, and at least 1 home visit (in the first week), with further home visits as required. Home visits lasted 60-90 min.

Control: hospital care from any member of the mother-child nursing team

OutcomesExclusive and partial breastfeeding at 4 weeks
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputerised block randomisation procedure (stratified by planned length of breastfeeding, parity and education).
Allocation concealment (selection bias)Unclear riskNot described
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot described
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot described
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk52 randomized, 51 appeared to complete the study, follow-up was 98%.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskRecruitment limited by availability of investigator. No baseline imbalance apparent.

Pugh 1998

Methods2-arm RCT, with individual randomisation n=60
Participants

Women were recruited at a community hospital in the USA and had diverse socioeconomic status.

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: women who experienced vaginal deliveries after full-term pregnancies

Exclusion criteria: not stated

Participant characteristics: mean age: 24.4 years; married n = 47 (78%); white n = 55 (93%); completed high school n = 58 (97%); income of USD ≤ 20,000 n = 13 (22%)

Interventions

Standard care included routine breastfeeding support in hospital following delivery.

Intervention: 2 home visits by a professional community health nurse and phone call from a qualified LC. The nurse provided a structured teaching and support protocol. The focus of the first visit was to enhance breastfeeding. For the second visit, of up to 2 h duration, mothers could choose the content from options including help with dishes or laundry. Most chose education or infant assessment; 2 asked for child care help so they could rest and/or spend time with a partner.

Control: home visit on day 3 or 4 by a hospital nurse (not specifically about breastfeeding).

Outcomes

Primary: duration of breastfeeding

Secondary: fatigue, symptoms of anxiety and depression

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskParticipants were randomly assigned to the treatment (n = 30) or control group (n = 30).
Allocation concealment (selection bias)Unclear riskNo information
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and caregivers were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome data were collected by a research assistant (by telephone). It was not clear whether blinding was achieved.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Not clear. Loss to follow-up was not mentioned and denominators were not provided for the results.

 

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this
Other biasUnclear riskLittle information was provided on study methods. No information provided about how many women were followed up, blinding, or how randomisation occurred.

Pugh 2002

Methods2-arm RCT, single-site study, recruitment April 1999-February 2000, n = 41; 21 assigned to intervention and 20 to control group
Participants

Community intervention in urban USA

Background rates of breastfeeding initiation: low

Inclusion criteria: low-income women receiving financial medical assistance

Exclusion criteria: not stated

Ethnic composition: 95.2% African American

Interventions

Intervention: breastfeeding support visits by community health nurse/peer counsellor team. Support offered daily when in hospital, and at home during weeks 1, 2 and 4 and at the team's discretion. Telephone support from peer counsellor twice weekly through to week 8 and monthly through to month 6.

Control: usual breastfeeding support consisted of support from hospital nurses, assistance by means of a telephone 'warm line' and if mothers gave birth on a weekday, 1 hospital visit from a LC.

OutcomesDuration of breastfeeding to 6 months; healthcare services use by infants; costs
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskDescribed as "assigned randomly".
Allocation concealment (selection bias)Low riskDescribed as "a sealed envelope technique".
Blinding of participants and personnel (performance bias)
All outcomes
High riskPeer supporters would have been aware of intervention. Not clear if women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessment by person or by phone; not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk41 women randomized, all appeared to have been followed up.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasLow riskGroups similar at baseline.

Pugh 2010

Methods2-arm RCT, with individual randomisation, n = 328
Participants

Setting: 2 hospitals (1 university and 1 community hospital) serving urban areas in Baltimore, Maryland, USA

Background rates of breastfeeding initiation: intermediate

Inclusion criteria: mother English-speaking, with phone access and living within 25 miles of the hospital, intending to breastfeed, family eligible for WIC program, singleton term infant (> 37 weeks’ gestation)

Exclusion criteria: infants or mothers with positive drug screen, infants with craniofacial abnormalities, infants admitted to NICU

Participant characteristics: all enrolled in WIC program; mean age  23.1 years; 87% African Americans; 26.5% with less than high school education; 79.6% single; 17.4% not employed or in school; 26.6% caesarean births; 50.6% first time mothers; 32.3% with previous breastfeeding experience

Interventions

Intervention (n = 168): in addition to usual care, a structured programme of education and support comprising postnatal visits by a breastfeeding team (community nurse and peer counsellor) daily in hospital, 2 home visits in the first week after discharge, a third visit at approximately 4 weeks, then scheduled phone calls by the peer counsellor at least fortnightly until 24 weeks and phone access to the community nurse (24 h) for 24 weeks. Home visits lasted approximately 45-60 min and the average length of phone calls was approximately 20 min.

Control (n = 160): usual care included access to a LC in hospital and phone access after discharge home

OutcomesAny breastfeeding (breastfed at least once during the previous 24 h) at 6, 12, and 24 weeks postpartum
NotesBaseline variables were measured using established valid instruments and were used as covariates to adjust for differences between randomisation groups in some of the analyses in the paper. In our analyses we have reported unadjusted figures.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence. Block randomisation (block size 10).
Allocation concealment (selection bias)Low risk“sealed envelope technique” ... not entirely clear, not described in detail but probably adequate.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBaseline data were collected before randomisation therefore this was collected in a blind fashion, however following randomisation women and staff would be aware of group assignment.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThere was a serious risk of bias associated with the lack of blinding of outcome assessors. In the intervention group outcome data were collected by the staff carrying out the intervention whereas in the control group outcome data were collected by a research interviewer who the women will not have met.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

70% of those approached randomized.

328 randomized and followed up, 29% lost to follow-up by 24 weeks but all women included in the analyses. Women who withdrew from the study early in the project were assumed not to be breastfeeding and those who were lost subsequently were assumed not to be breastfeeding since their last contact. Both I and C groups were treated in the same way and loss was similar in the 2 groups. The numbers recorded as still breastfeeding therefore represent a conservative estimate.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol.
Other biasUnclear riskThere was no apparent baseline imbalance although baseline characteristics were used in regression analysis to determine adjusted treatment effect. In our results we have reported the unadjusted data.

Quinlivan 2003

Methods2-arm RCT, single-site study, recruitment July 1998-December 2000, n = 136
Participants

Urban Australia

Background rates of breastfeeding initiation: high. Baseline prevalence of breastfeeding in Australia = 83% at hospital discharge

Participants were recruited at a teenage pregnancy clinic serving mostly disadvantaged young women. The intervention was offered regardless of feeding intention or practice.

Inclusion criteria: teenagers aged < 18 years; attending first antenatal appointment at public-care teenage pregnancy clinic for first-time mothers; English-speaking; intending to continue with the pregnancy and not relinquish the infant

Exclusion criteria: residence > 150 km from the study hospital; known fetal abnormality

Participant characteristics:

Ethnic composition of sample: 24% indigenous Australian

Socioeconomic status: 86.5% of sample scored low or destitute on score derived from educational level of participant and her parents, and family income

Interventions

Intervention: structured home visits in weeks 1 and 2 by certified nurse-midwives to teach feeding and maternal-infant bonding skills. Further visits at months 1, 2, 3 and 4 to provide advice and support.

Control: routine postnatal support, counselling and information services provided by the hospital including access to routine hospital domiciliary home-visiting services

OutcomesAdverse neonatal outcomes (infant death, severe non-accidental injury and non-voluntary foster care); knowledge and practice of contraception, vaccination schedules and breastfeeding
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskBy computer-generated randomized allocation schedule
Allocation concealment (selection bias)Low riskConcealed in numbered, sealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and staff aware of intervention group.
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessors aware of intervention group.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk65 assigned to the intervention and 71 to the control group. Reasons for drop out recorded, 124 completed trial (91%).
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear risk

It was not clear how the intervention related to some of the outcomes (e.g. early infant death).

No baseline imbalance apparent with similar numbers of women in the 2 groups initiating breastfeeding.

Ransjo-Arvidson 1998

Methods2-arm quasi-RCT, recruitment 1989-1992 n=408
Participants

Setting: study in a hospital in Zambia

408 women recruited 1 h following delivery at the study hospital

Inclusion criteria: normal birth, term, singleton, Apgar score > 7 at 1 min, no visible malformation and mother and baby assessed as healthy

Interventions

Intervention (n = 208): home visits by a midwife at 3, 7, 28 and 42 days. Home visits lasted about 1 h. Midwives examined women and infants and asked about their health; any health problems and related actions; breastfeeding patterns; social support (if any). If indicated, midwives referred women for medical help.

Control (n = 200): home visit by a midwife at 42 days only

OutcomesMaternal and infant health problems
NotesWe have not included data from this study in the review as they were not reported in a way that allowed us to enter them into RevMan 2014 for meta-analysis. Numbers of breastfeeding women were not reported by randomisation group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk2-stage randomisation process with recruitment on certain days, when women were randomly selected to be randomized to treatment groups.
Allocation concealment (selection bias)Unclear riskIt was not clear whether the person carrying out the randomisation had any control over the sample selection and the randomisation process.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskHospital staff were unaware of group allocation. Unclear if midwife delivering intervention and women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData were collected by research midwives but unclear if they were blinded to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Participants seen at follow-up for the intervention group- 98.5% at day 3, 97.5% at day 7, 87% at day 28 and 89% at day 42.

Participants seen at follow-up for the control group - 87% at day 42.

Loss to follow-up < 20% at each follow-up visit.

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskBaseline characteristics were similar.

Redman 1995

Methods2-arm RCT n=235
Participants

Setting: 235 eligible and consenting women booked for delivery at an Australian hospital in 1989

Inclusion criteria: primiparous women who expressed a wish to breastfeed, who booked for delivery before 20 weeks’ gestation, aged between 18-35 years and lived within 20 km of the  hospital

Exclusion criteria: women who received additional care from independent midwives  

Interventions

Intervention: programme of care based on health belief model and cognitive-behavioural principles, including a 3-h group teaching session in the antenatal period and a visit by a LC shortly after hospital birth, phone support 2-3 weeks later and at 3 months, with a home visit if needed. The LC was available to provide telephone support at other times.

Control: usual breastfeeding care and advice along with routine antenatal classes

OutcomesBreastfeeding at 6 weeks and 4 months postdelivery, reasons for stopping breastfeeding, satisfaction with the intervention
NotesWe have not included data from this study in the review due to very high attrition rates which meant results were difficult to interpret. In this study women were recruited in the antenatal period. 235 women were randomized; 30% were lost to follow-up by 6 weeks postpartum (and full interview data were available for only 56% of the sample).  
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskAlternate, by odd or even numbered consent forms. It was stated that forms were given out sequentially.
Allocation concealment (selection bias)Unclear riskOdd or evenly numbered consent forms. It was stated that those carrying out recruitment and the women were not aware of the code for allocation.
Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and personnel were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData were collected using a self-completed questionnaire. it is not detailed if the questionnaire contained any information that could identify allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskHigh loss to follow-up with interview data at 6 weeks for only 56% of the sample randomized.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskBaseline characteristics similar - no significant differences between control and intervention groups on any of these variables.

Santiago 2003

Methods3-arm RCT, with individual randomisation, single-site study, recruitment August 2000-July 2002, n = 101
Participants

Urban setting in Minas Gerais, Brazil

Background rates of breastfeeding initiation: high. Baseline prevalence of breastfeeding in Brazil in the first 30 days = 88%

Inclusion criteria: mother breastfeeding her well, term baby when appointment for paediatric clinic made; first clinic consultation took place at ≤ 30 days

Exclusion criteria: mothers who expressed a preference to see a particular paediatrician; babies no longer breastfed at the first appointment

Ethnic composition: 62% of babies white

Interventions

Intervention 1: babies were monitored by a paediatrician working with a multidisciplinary breastfeeding team. The paediatrician and team had all received training to promote exclusive breastfeeding (PNIAM: Programa de Incentivo ao Aleitamento Materno, Brazil).

Intervention 2: babies were monitored by the same paediatrician, in individual consultations.

Control: babies were monitored by a paediatrician who did not have formal training to promote exclusive breastfeeding.

OutcomesExclusive breastfeeding to 4 months
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk(Risk of bias assessment from translation notes.) Random assignment by drawing lots.
Allocation concealment (selection bias)Unclear riskRandom assignment by drawing lots. Described as simple randomisation in translation notes.
Blinding of participants and personnel (performance bias)
All outcomes
High riskIt was stated that staff were aware of group assignment. It is unclear if women were aware of allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt is stated that "information was collected by the author of each child's medical record. it is unclear if it was 1 of the paediatricians that completed or if it was someone who was blinded to allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskIt was not clear at what time randomisation took place or the number randomized to each group "the exclusion percentages were similar in the three groups". 190 were eligible and 101 completed the study.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskNo baseline imbalance apparent. It was not clear how many women were randomized.

Serafino-Cross 1992

Methods2-arm RCT, with individual randomisation, recruitment 1986-1987, n = 52
Participants

Volunteers attending prenatal clinics in Massachusetts USA who intended to breastfeed their babies for 2 months or longer

Background rates of breastfeeding initiation: low

Inclusion criteria: breastfeeding for the first time, or unsuccessful previous attempts; English-speaking

Interventions

All women received prenatal breastfeeding information.

Intervention (n = 26): home visits and telephone contacts up to 2 months postpartum from an experienced breastfeeding counsellor (who also recruited women to the study). Women received 5-8 visits lasting 30-60 min.

Control (n = 26): usual care; women were given contact details for the clinic nutritionist to use if problems arose.

OutcomesBreastfeeding at 2 months postpartum and 6 months postpartum
NotesWe were only able to include 1 reported result in the review: numbers breastfeeding (any) at 8 weeks postpartum. The remaining data were in a graph and were not easy to interpret or data were not reported by randomisation group.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot described
Allocation concealment (selection bias)Unclear riskMethod not described as “randomized the clients”.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThe researcher provided the intervention and would have been aware of group allocation. Women would have been aware if they were to receive the intervention or not.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskWomen were contacted by phone or mail to complete questionnaires. Not stated who did the data collection and whether they were blinded.
Incomplete outcome data (attrition bias)
All outcomes
High risk52 women were recruited. It appeared that all women were followed up at 8 weeks postpartum, but that approximately half of  the comparison group were lost to follow-up by 6 months. We have not included any data in the review relating to the outcomes measured at 6 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskVery low recruitment rate “it took 14 months to enrol just 52 participants from 4 clinics serving in total approximately 1000 pregnant women per year”. Results may not be generalisable.

Sikander 2015

Methods2-arm cluster-RCT, n = 452
Participants

Union Councils in a rural, resource-poor district in the northwest province of Pakistan with high infant mortality

Background rates of breastfeeding initiation: Pakistan has 8% exclusive breastfeeding before 6 months.

inclusion criteria: women aged 17-40 years, married, in their third trimester of pregnancy, and intending to reside in the study area for the duration of the study

Exclusion criteria: women with diagnosed serious medical/psychiatric condition requiring treatment, pregnancy-related illness (except for common conditions, such as anaemia), and substantial physical/learning disability

Interventions

Intervention (n = 224): 7 psycho-educational sessions integrated into the routine work of lady health workers (LHWs) and delivered to all women in their Union Council catchment areas. First session delivered before birth, second session immediately after birth, and the remaining 5 sessions monthly thereafter. The intervention had 6 components: developing an empathic relationship: a trusting, safe, alliance with the mother and other family members; collaborating with the family in an equal partnership; using guided discovery: a style of engagement to gently probe for the individual and family’s health beliefs, and also to stimulate alternative ideas; putting knowledge into practice and behavioural activation; and problem solving. LHWs underwent 2-day (12 h) training in simplified cognitive behavioural therapy principles using participatory approaches.

Control (n = 228): women received an equal number of visits in exactly the same way as those in the intervention arm, but by routinely trained LHWs.

Outcomes

Primary: rate and duration of exclusive breastfeedingin the first 6 months

Secondary: impact on traditional practices impeding exclusive breastfeeding

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "Simple unmatched randomization"
Allocation concealment (selection bias)Low riskRandomisation by an independent researcher
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and LHWs were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskThe assessors were blind to the allocation status of the mother
Incomplete outcome data (attrition bias)
All outcomes
Low risk19% attrition in intervention group and 22% attrition in control group in 6 months after birth.
Selective reporting (reporting bias)Low riskAll outcomes in protocol were reported on.
Other biasLow riskNone identified

Simonetti 2012

Methods2-arm RCT, n = 114
Participants

Public maternity hospital in Italy

Background rates of breastfeeding initiation: not stated

Inclusion criteria: healthy primiparous women without breastfeeding problems, with a healthy baby born at full term (37–41 weeks, birthweight > 2500 g) and who agreed to be enrolled

Exclusion criteria: multiparous women, premature baby (born before the 37th week), low birth weight baby (< 2500 g), admission to neonatal intensive care unit or transfer to another hospital, medical condition which could permanently or temporarily counter-indicate breastfeeding (e.g. acute tuberculosis, psychosis, acute phase hepatitis A or B, hepatitis C, HIV), women who did not speak Italian, and women who could not be contacted by telephone).

Interventions

Intervention (n = 55): structured telephonic counselling (STC); each mother received telephone calls during the first 6 weeks after delivery. The phone call timing was planned by both the mother and the licensed midwife (LM) with at least one a week; in addition, mothers were invited to call the LM when necessary to solve any breastfeeding problem. During every phone call, the LM gave support and all information on fully breastfeeding. No weekly calls were missed.

Control (n = 59): conventional counselling - consisting of programmed periodical visits with the physician at 1, 3 and 5 months after delivery. Participants were also invited to call the LM in case of breastfeeding problems.

Outcomes

Primary: breastfeeding at 1,3 and 5 months after delivery

Secondary: influence of mother’s educational level and employment status on exclusive breastfeeding

NotesNone identified
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "Women who consented to participate were randomly assigned to 1 of the 2 groups, 55 women were enrolled in the experimental group (receiving STC) and 59 were enrolled in the control group (receiving conventional counselling)". Sequence generation not described.
Allocation concealment (selection bias)Unclear riskNo detail provided to enable judgement of this.
Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not possible due to nature of intervention.
Blinding of outcome assessment (detection bias)
All outcomes
High riskThe data were collected by a specialist nurse who monitored all subjects.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot clear if all women who were randomized completed study as numbers not provided
Selective reporting (reporting bias)Unclear riskNo evidence that outcomes were prespecified
Other biasLow risk 

Sjolin 1979

MethodsQuasi-RCT, single site, duration 12 months, n = 146
Participants

Urban Sweden - maternity ward of University Hospital

Background rates of breastfeeding initiation: high. Baseline prevalence (1972): 4% breastfeeding at 24 weeks

Inclusion criteria: resident in Uppsala; normal birth; healthy babies weighing > 3 kg

Exclusion criteria: none specified

Ethnic composition not stated. 28% of mothers had completed college or university education

Interventions

Intervention: 'Interview' with paediatrician in hospital on days 1 and 4, and at home at 2 and 6 weeks and 3 months; telephone contact weekly while breastfeeding followed by home visit if problem noted.

Control. Usual care,

OutcomesPartial and exclusive breastfeeding at 2, 4, 8, 12, 16, 20 and 24 weeks
NotesPrimarily designed as a study of the reasons for breastfeeding difficulties and the cessation of breastfeeding. Recruitment halted during holidays.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskQuasi-randomisation depending on time of day of birth
Allocation concealment (selection bias)High riskQuasi-randomisation
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskWomen in the control group were not told about the study until the 6 months follow-up interview. Not stated if women in the intervention group were aware of study.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskAll interviews were carried out by the same investigator who was aware of group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInterviews took place while women continued to breastfeed and it was not clear how many women remained to follow-up at different points although no drop-out was reported for the final data collection interview at 6 months.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear riskWomen in the intervention group reported outcomes at scheduled interviews, whereas the control group were interviewed at 6 months postpartum only. Recall and response bias may have been different in the 2 groups.

Srinivas 2015

Methods2-arm RCT, n = 120
Participants

Westown Physician Center (WPC), a hospital-affiliated urban clinic, USA, where most patients received public insurance or charity care

Background rates of breastfeeding initiation: data from an inner-city Cleveland clinic with a similar population reported lower rates with any and exclusive breastfeeding at 5 days at 40.8% and 22.0%, respectively.

Inclusion criteria: aged18 years or older, with no contraindications to breastfeeding, ≥ 28 weeks’ gestation at recruitment stage

Exclusion criteria: women < 18 years old, non-English speakers, and those with a diagnosis that was an absolute contraindication to breastfeeding (HIV/AIDS, herpes simplex on the breast, tuberculous lesions of the breast)

Interventions

Intervention (n = 50): peer counselling WIC support programme; WIC definition of a breastfeeding peer counsellor: a woman who breastfed her own infant(s) to 1 year with exclusive breastfeeding for 6 months or was currently breastfeeding an infant following recommended practice, who received 20 h training. Counsellor was resident in the local area and received care herself from WPC. Antenatal: peer counsellor initiated contact once during third trimester of pregnancy with additional contacts at mother's request (mostly by telephone). Postnatal: peer counsellor contact within 3-5 days of birth weekly to 1 month, every 2 weeks up to 3 months, and once at 4 months, in person during clinic visits or via telephone. No home visits for safety reasons.

Control (n = 53): standard care (available to both intervention and control group), included access in hospital to International Board Certified LCs and outpatient lactation support from the clinic paediatricians and the WIC nutritionist. The in-office WIC site had a peer helper available less than once a month.

Outcomes

Breastfeeding initiation

Any breastfeeding at 1 month and 6 months

Exclusive breastfeeding at hospital discharge, 1 month, 6 months

Breastfeeding attitude and self-efficacy

Perception of breastfeeding support

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote: "participants were ran-domized within these strata in blocks of 4 participants in a 1:1 ratio to intervention (PC) or control (usual care) group". Method of sequence generation not described.
Allocation concealment (selection bias)Unclear riskNo detail provided to enable judgement of this.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThe peer counsellor was blinded to self-efficacy and attitude towards breastfeeding, but due to the nature of the intervention would have been aware of the allocation of the women. It was not stated whether the women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskStudy co-ordinator administered exit interview and it was not stated whether the co-ordinator was blinded to group allocation.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNumber initially randomized not provided, so unable to calculate attrition rate.
Selective reporting (reporting bias)Unclear riskNo evidence of a record of predefined outcomes to judge this.
Other biasLow riskNone identified

Stockdale 2008

Methods2-arm RCT, n = 182
Participants

Suburban hospital and community health and social services trust that served both urban and rural areas in Northern Ireland

Background rates of breastfeeding initiation: not detailed

Inclusion criteria: primigravid women who intended to have their baby within the trust and who attended the routine 20-week antenatal appointment during the recruitment phase

Exclusion criteria: women who did not speak English (or had interpretation services available), women who experienced infant-maternal separation and incidences of newborn abnormalities that required additional infant feeding support, or teenagers who had already attended a breastfeeding workshop

Interventions

Intervention (n = 93): motivationally-enhanced version of midwife instruction as a means of increasing women's expectancy for successful breastfeeding, compared to best practice. The intervention had 4 components: antenatal feeding class (32-36 weeks' gestation), a breastfeeding information book (provided in the antenatal phase), a breastfeeding CD-ROM, postnatal instructional support provided by midwives (up to 3 weeks postnatal) and additional lactation consultancy on request. The postnatal midwives who supported the intervention attended an additional 1-day training session that focused on the role of human motivation and the use of effective strategies to increase participants' expectancy for success.

Control (n = 89): local best practice

Outcomes

Primary: women's motivation towards breastfeeding

Secondary: breastfeeding on discharge from hospital and at 3 weeks

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipants were assigned using computer-generated random numbers to the intervention or control groups.
Allocation concealment (selection bias)Unclear riskNo details provided to enable judgement of this.
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipants were blinded to group membership but unclear if this was successful. Midwives were informed of the allocation through a colour-coded sticker on the women-held records.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot stated whether researcher or parent education co-ordinator who collected the data were blinded.
Incomplete outcome data (attrition bias)
All outcomes
High riskAttrition in intervention group was 26% and in control group was 16%. The withdrawal rate was higher in the intervention group (n = 13) compared to the control group (n = 2).
Selective reporting (reporting bias)Unclear riskNo evidence of prespecified outcomes to judge this.
Other biasLow riskNone identified

Su 2007

Methods3-arm RCT, with individual randomisation, n = 450
Participants

National University Hospital, Singapore

Background rates of breastfeeding initiation: high

Inclusion criteria: healthy pregnant women attending antenatal clinics at the study hospital, with no illness that would contraindicate breastfeeding or severely compromise its success; intending to breastfeed; birth at 34 weeks' gestation or later

Exclusion criteria: women with high risk and multiple pregnancies

Participant characteristics:

40% primiparous, mixed ethnicity (Chinese 31%-44%, Malay 46%-54%, Indian and other), approximately a third educated beyond secondary school, approximately half employed outside the home, 56% had previously breastfed

Interventions

Intervention 1: antenatal education: in addition to routine care, women received 1 session of antenatal breastfeeding education and printed guides on breastfeeding.

Intervention 2: postnatal lactation support: in addition to routine care, women received 2 postnatal sessions with a LC, 1 in hospital within the first 3 postnatal days (when they received the same printed guides on breastfeeding as the antenatal education group) and 1 during the first routine postnatal visit 1 to 2 weeks after the birth. Each session lasted about 30 min and covered latching on, proper positioning and other techniques to avoid common breastfeeding complications.

Control: women received routine antenatal, intrapartum and postnatal care, including optional antenatal classes and postnatal visits by a LC should any problems with breastfeeding arise.

OutcomesExclusive and any breastfeeding at hospital discharge and 2 weeks, 6 weeks, 3 and 6 months after the birth. Exclusive breastfeeding was defined as giving breast milk as the only food source, with no other foods or liquids, other than vitamins and minerals being given.
NotesIntervention group 1, who received the antenatal intervention, are not included in the analysis in this review.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence by external clinical trials unit
Allocation concealment (selection bias)Low riskTelephone allocation by external trials unit (with envelope back up used only on 4 occasions)
Blinding of participants and personnel (performance bias)
All outcomes
High riskFor participants, blinding was not mentioned, but women would be aware of allocation. The caregivers who delivered the intervention would be aware of allocation.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData collection was on standard forms and was entered by remote unit, therefore outcome assessment may have been partially blinded. Not clear who conducted the actual interviews.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk

Low attrition in all arms. In total 450 randomized 347 completed follow-up at 6 months (82%). In the data and analyses, 2 arms included 299 randomized, 245 followed up at 6 months (82%).

 

Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear risk

There was an imbalance in the groups due to 4 women being randomized by using back up envelopes because of dysfunction in web randomisation, but groups appeared similar at baseline.

Some of the data were based on assumptions. Sensitivity analyses were based on the assumption that none of the women lost to follow-up were exclusively breastfeeding at any time point.

Tahir 2013

Methods2-arm RCT, n = 357
Participants

Public maternity hospital in Kuala Lumpur

Background rates of breastfeeding initiation: 92.2% of mothers were exclusively breastfeeding at the study site before discharge.

Inclusion criteria: 18 years of age or older; of Malaysian nationality; delivered a single infant at ≥ 37 weeks' gestation; an intention to breastfeed and the ability to understand and communicate in spoken Malay or English; had received a prenatal breastfeeding education programme at least once; had telephone access; and gave informed consent

Exclusion criteria: women with multiple pregnancies or medical problems that might hinder breastfeeding; women that delivered via caesarean section; or women whose baby subsequently required prolonged care in a Special Care Nursery

Interventions

Intervention (n = 179): lactation counselling given by certified LCs via telephone twice monthly to each lactating mother, in addition to the current conventional care (as descried below). Each mother was expected to receive 12 lactation counselling sessions by the end of the study. Contact was discontinued any time that a mother decided to stop breastfeeding completely. Contact was also discontinued if the mother had given the baby up for foster care and/or had no physical contact to enable her to breastfeed. LCs in this study were registered nurses from the Maternity Hospital Kuala Lumpur who had post-basic training in midwifery and were certified as LCs. All 12 LCs had undergone a 40-h lactation management and counselling course based on the WHO module.

Control (n = 178): mothers received current conventional care for postnatal breastfeeding promotion or support from thier own public healthcare provider. This conventional care included breastfeeding talks during immunisation follow ups, a mothers’ communication with the LCs through information or pamphlets received during antenatal or postnatal follow-ups, and advice regarding breastfeeding received at any time from any healthcare workers, the media, peer counsellors, family members or friends.

Outcomes

Exclusive breastfeeding at 1, 4 and 6 months

Stopped any breastfeeding at 1, 4 and 6 months

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskQuote: "Generation of the group assignments was conducted using a blocked randomisation method with a block size of four by a random allocation software program"
Allocation concealment (selection bias)Unclear riskNo details provided to enable judgement of this.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThe women and LCs were not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskQuote: "Only the Research Enumerator who collected the breastfeeding outcome data was blinded with respect to the treatment group"
Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition in intervention and control group was 89.4% and 88.8% respectively.
Selective reporting (reporting bias)Unclear riskNo evidence of predefined outcomes to judge this.
Other biasLow riskNone identified

Tylleskar 2011a

MethodsOne of the 3 country sites that completed this cluster-randomised trial - Burkino Faso in French-speaking West Africa (24 clusters: 12 intervention, 12 control). Mother-infant pairs enrolled: 392 intervention and 402 control (794 total). Followed up at 24 weeks: 359/392 (92%) intervention and 372/402 (93%) control
Participants

Rural area where main source of income was farming. 60 primary care facilities and a regional hospital

Baseline prevalence of breastfeeding initiation: high (98.4%). Exclusive breastfeeding for babies under 6 months estimated at 16%

Inclusion criteria: women living in trial area at least 7 months pregnant and intending to breastfeed, singleton live birth, no serious congenital malformations

Exclusion criteria: mothers or infants who died were not included in the analysis

Participant characteristics:

Mean age of women 25 years. None of the women had any formal education and more than half had had a previous child death. 99% of women had no toilet or an open toilet and < 1% had piped water in yard or home. Monthly income was approximately EUR 3.

Interventions

Intervention: peer counselling by supporters who received a modified version of WHO/UNICEF training (1 week training). Women were given information about breastfeeding and peers provided support and addressed problems or referred women for specialist help. The intervention involved a minimum of 5 home visits, 1 in the third trimester and at least 4 in the postnatal period up to 6 months postpartum. The supporters were local residents, literate, able to travel to visit women in their homes and had a good reputation in the community. Peer counsellors visited the same women each time to achieve continuity of care. The intervention varied in the 3 study areas and was adapted to local circumstances.

Control: mothers and infants in control clusters in Burkina Faso were given standard healthcare only.

OutcomesPrevalence of exclusive breastfeeding and prevalence of diarrhoea, reported by mothers for infants aged 12 weeks and 24 weeks
NotesThe paper reported that current breastfeeding was assessed at all scheduled postpartum visits using past 24-h and 7-day recalls. Babies who were reported to have received no other food or liquids than breast milk (they may have been administered drugs) were classified as exclusively breastfed. This may have been during the last 24 h or 7 days rather than since birth. Prevalence of diarrhoea was based on the mothers’ reports of the past 2 weeks.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear (different procedures in different areas and the procedure in 1 of the 4 areas was not clear) .
Allocation concealment (selection bias)Unclear riskThere was no allocation concealment within clusters and participants would be aware of assignment.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThere was no participant or staff blinding.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThere was an attempt to mask/blind outcome assessors to randomisation group, although it is possible women would have revealed whether or not they received support. The success of attempted blinding was not formally evaluated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was flooding in 1 of the 4 original study area and no results were reported for this area. For the remaining 82 clusters in 3 countries for primary outcomes the authors carried out an ITT analysis (i.e. those that were missing were recorded as non-events, i.e. NOT exclusive breastfeeding and no diarrhoea). 2579 women enrolled. Missing data and missed visits at various data collection points.
Selective reporting (reporting bias)Unclear riskNot apparent
Other biasUnclear risk

Recruitment procedures and intervention delivery was slightly different in each of the study countries which meant that results were difficult to interpret. It was reported that the ICC in each country for primary outcomes varied considerably and therefore results were reported separately for each country.

Authors stated, “The community-based approach could possibly have resulted in socially desirable answers, and the results were based on self-reports. A bias towards desirable answers and thereby an increased effect size cannot be ruled out. We also noted some questionnaire fatigue in the Ugandan site—i.e. reluctance to fully engage in answering similar questions after a few interviews".

Tylleskar 2011b

MethodsSecond of 3 country sites that completed the cluster-randomised trial - Mbale district in Eastern Uganda (24 clusters: 12 intervention, 12 control). Mother-infant pairs enrolled: 396 intervention and 369 control (765 total). Followed up at 24 weeks: 368/396 (93%) intervention and 329/369 (89%) control
Participants

Urban and rural areas: urban area included “large slum migrant settlements”.

Background rates of breastfeeding initiation: high (> 95%)

Inclusion criteria: women living in trial area at least 7 months pregnant and intending to breastfeed, singleton live birth, no serious congenital malformations

Exclusion criteria: mothers or infants who died were not included in the analysis

Participant characteristics:

HIV prevalence for fertile women was 6.2%. 26% of women had no toilet or an open toilet and 5% had piped water in yard or home. Mean age 25 years. Women had approximately 6 years of formal education and approximately a third had had a previous child death. Monthly income was approximately EUR 12.

Interventions

Intervention: peer counselling as in Burkina Faso (Tylleskar 2011a). Paper stated the intervention varied in the 3 study areas and was adapted to local circumstances.

Control: mothers and infants in control clusters in Uganda were given standard healthcare only.

OutcomesPrevalence of exclusive breastfeeding and prevalence of diarrhoea, reported by mothers for infants aged 12 weeks and 24 weeks
NotesThe paper stated that current breastfeeding was assessed at all scheduled postpartum visits using past 24-h and 7-day recalls. Babies reported to have received no other food or liquids than breast milk (they may have been administered drugs) were classified as exclusively breastfed. This may have been during the last 24 h or 7 days rather than since birth. Prevalence of diarrhoea was based on the mothers’ reports of the past 2 weeks.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear (different procedures in different areas and procedure in 1 of the 4 areas was not clear)
Allocation concealment (selection bias)Unclear riskThere was no allocation concealment within clusters and participants would be aware of assignment.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThere was no participant or staff blinding.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThere was an attempt to mask/blind outcome assessors to randomisation group, although it was possible women would have revealed whether or not they received support. The success of attempted blinding was not formally evaluated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was flooding in 1 of the 4 original study area and no results were reported for this area. For the remaining 82 clusters in 3 countries for primary outcomes the authors carried out an ITT analysis (i.e. those that were missing were recorded as non-events, i.e. NOT exclusive breastfeeding and no diarrhoea). 2579 women enrolled. Missing data and missed visits at various data collection points.
Selective reporting (reporting bias)Unclear riskWe did not have access to the trial registration or protocol, so could not assess this.
Other biasUnclear risk

Recruitment procedures and intervention delivery was slightly different in each of the study countries which meant that results were difficult to interpret. It was reported that the ICC in each country for primary outcomes varied considerably and therefore results were reported separately for each country.

Authors stated, “The community-based approach could possibly have resulted in socially desirable answers, and the results were based on self-reports. A bias towards desirable answers and thereby an increased effect size cannot be ruled out. We also noted some questionnaire fatigue in the Ugandan site—i.e. reluctance to fully engage in answering similar questions after a few interviews".

Tylleskar 2011c

MethodsThird of 3 country sites that completed this cluster-randomised trial - 3 geographically separate sites in South Africa (Paarl, a town at the centre of a farming district near Cape Town; Umlazi, a large periurban township near Durban; and Rietvlei, 1 of the country's poorest rural districts: 34 clusters: 17 intervention, 17 control). Mother-infant pairs enrolled: 535 intervention and 485 control (1020 total). Followed up at 24 weeks: 461/535 (86%) intervention and 410/485 (85%) control
Participants

South Africa (3 areas including 1 of the poorest rural area in South Africa)

Under 5 mortality rate in South Africa was 67/1000 and infant mortality rate was 48/1000.

Background rates of breastfeeding initiation: high (> 95%). Exclusive breastfeeding at 6 months was estimated at 8% in 2005-2009.

Inclusion criteria: women living in trial area at least 7 months pregnant and intending to breastfeed, singleton live birth, no serious congenital malformations

Exclusion criteria: mothers or infants who died were not included in the analysis

Participant characteristics:

16% of women had no toilet or open toilets and 66% had piped water in yard or home. Mean age 23 years. Women had approximately 10 years of formal education and approximately 7% had had a previous child death. Monthly income was approximately EUR 103.

Interventions

Intervention: peer counselling as in Burkina Faso and Uganda (Tylleskar 2011a; Tylleskar 2011b). Paper stated the intervention varied in the 3 study areas and was adapted to local circumstances.

Control: control clusters were visited by peer counsellors, with the same schedule as the intervention clusters, but they assisted families in obtaining birth certificates and social welfare grants. The peer counsellors for the intervention and control clusters in South Africa were kept separate during the study.

OutcomesPrevalence of exclusive breastfeeding and prevalence of diarrhoea, reported by mothers for infants aged 12 weeks and 24 weeks
NotesThe paper stated that current breastfeeding was assessed at all scheduled postpartum visits using past 24-h and 7-day recalls. Babies reported to have received no other food or liquids than breast milk (they may have been administered drugs) were classified as exclusively breastfed. This may have been during the last 24 h or 7 days rather than since birth. Prevalence of diarrhoea was based on the mothers’ reports of the past 2 weeks.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskUnclear (different procedures in different areas and procedure in 1 of the 4 areas was not clear)
Allocation concealment (selection bias)Unclear riskThere was no allocation concealment within clusters and participants would be aware of assignment.
Blinding of participants and personnel (performance bias)
All outcomes
High riskThere was no participant or staff blinding.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThere was an attempt to mask/blind outcome assessors to randomisation group although it is possible women would have revealed whether or not they received support. The success of attempted blinding was not formally evaluated.
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere was flooding in 1 of the 4 original study area and no results were reported for this area. For the remaining 82 clusters in 3 countries for primary outcomes the authors carried out an ITT analysis (i.e. those that were missing were recorded as non-events, i.e. NOT exclusive breastfeeding and no diarrhoea). 2579 women enrolled. Missing data and missed visits at various data collection points.
Selective reporting (reporting bias)Unclear riskNot apparent
Other biasUnclear risk

Recruitment procedures and intervention delivery was slightly different in each of the study countries which meant that results were difficult to interpret. It was reported that the ICC in each country for primary outcomes varied considerably and therefore results were reported separately for each country.

Authors stated, “The community-based approach could possibly have resulted in socially desirable answers, and the results were based on self-reports. A bias towards desirable answers and thereby an increased effect size cannot be ruled out. We also noted some questionnaire fatigue in the Ugandan site—i.e. reluctance to fully engage in answering similar questions after a few interviews".

Vidas 2011

Methods2-arm RCT, n = 100
Participants

Setting not clear. "Our research was conducted by the Association for a healthy and happy childhood-Counseling center for mother and child in Bjelovar, Croatia”– not obvious what type of setting this is, but we infer it is a community-based setting of some sort.

Background rates of breastfeeding initiation: 50% of women give-up breastfeeding after 6 months in Croatia

Inclusion criteria: "the criterion for inclusion in the study was that the mother was nursing her child and the child had up to two months"

Exclusion criteria: none stated

Interventions

Intervention (n = 50): “six basic exercises of autogenic training". Not clear what this is but article states "every two weeks mothers were practicing a new exercise. The 6 basic exercises of autogenic training were taught for 12 weeks in small groups to 10 members". "After mothers have learned all the exercises of autogenic training, they have continued to practice until their child reached six months of life". The exercises seem to be delivered in a group setting and promoted breastfeeding.

Control (n = 50): unclear; Quote "mothers of both groups were advised to successful breastfeeding up to 6 months of age"

Outcomes

Attitude, decision and duration of breastfeeding

Mother’s level of confidence

Motivation for successful breastfeeding

Motivation for autogenic training

Possible factors influencing breastfeeding

Risk factors for postpartum mental disorders, anxiety and postpartal depression

Degree of satisfaction with practising autogenic training and its possible role in promoting successful breastfeeding in the examined group

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo information given on sequence generation. Only information about randomisation process was “Mothers were randomly divided into two groups-examined and control".
Allocation concealment (selection bias)Unclear riskNo information given on allocation concealment. Only information about randomisation process was “Mothers were randomly divided into two groups-examined and control".
Blinding of participants and personnel (performance bias)
All outcomes
High riskNature of trial meant that participants and personnel would have been aware of group assignment.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information given about blinding of outcome assessment for any outcome.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo information given in paper on the numbers assessed for outcomes, other than for breastfeeding at 6 months where the authors reported numbers for each arm and the data. Fig 4 implied they had complete outcome data for this – for all other outcomes it was unclear what number of participants in each arm were assessed for each outcome.
Selective reporting (reporting bias)High riskNo statement of the original prespecified primary and secondary outcomes for the trial. No link to trial registry or protocol information which would enable discernment of any selective outcome reporting (or the lack of it).
Other biasLow riskNone identified

Vitolo 2005

Methods2-arm RCT, with individual randomisation, n = 500
Participants

Setting: urban, a low-income area of the city of São Leopoldo, Rio Grande do Sul, Brazil. Recruitment from maternity wards of the city's only publicly funded hospital, which mainly serves the low-income population.

Background rates of breastfeeding initiation: high

Inclusion criteria: low-income mothers with healthy, singleton, full-term (> 37 week) babies with birthweight > 2500 g

Exclusion criteria: impediments to breastfeeding, HIV/AIDS, or congenital malformation

Demographics: 57% male children; 60% of intervention and 52% of control mothers had less than 8 years schooling; 73% of intervention and 67% of controls had low annual incomes (< USD 3000); 34% of mothers were not in paid work; 70% of children were living with mother and father; almost half of the mothers were overweigh