Methods

RCT, 3‐arm trial with individual randomisation.

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). The study hospitals 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 less than 6 months breastfeeding exclusively. It was reported that "almost all" mothers initiated  breastfeeding.

231 women randomised (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 or more at 1 and 5 min.

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

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

Interventions

All 3 groups (Intervention group 1, Intervention group 2 and control group) 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 additional to standard care. The content of the sessions differed between the 3 groups. 63% of group 1, 73% of group 2 and 65% of control group women received all 9 scheduled home follow‐up visits.

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

Intervention group 1: 74 randomised, 43 followed up. Content of sessions was breastfeeding and exclusive breastfeeding. The 2 educational sessions, of approximately 20 minutes each, were given by trained local nurses with experience of breastfeeding to groups of 2‐4 women during the 3^rd trimester. At the 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 group 2: 72 randomised, 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 group 1.

Outcomes

Breastfeeding status at 1, 2, 3, 4, 5, and 6 months exclusive breastfeeding up to 6 months, infant morbidity and growth.

Notes

We 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“Randomization was achieved by writing numbers 1 to 3 on folded pieces of paper."

Allocation concealment (selection bias)

High risk

"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.”

“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 (performance bias and detection bias)
outcome assessors

High risk

Participants: "were not aware of their group allocation or of differences in the content of the health education. " However, women in all 3 intervention arms received an intervention. Women would be aware that they had received an intervention although they may not have been aware of what women in other groups received.

Staff: "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 randomised during the 3rd 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 randomised 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 risk

Failure to provide denominators for results means that they are very difficult to interpret.

Other bias

Unclear risk

Women in the 3 arms of the trial appeared similar at baseline. Analysis was according to group allocation.

Methods

RCT (n = 66) single site, a Baby‐Friendly hospital, March to July 2008.

Participants

Urban state maternity hospital in Turkey. Background rates of breastfeeding initiation: high.

Inclusion criteria: primaparous, live vaginal birth, healthy term singleton infant, lives in study area, speaks Turkish, no history of chronic diseases, non‐smoker, intends 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 6.10.2011).

Interventions

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

The intervention group 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, that lasted about 30 minutes and covered the same topics as routine support.

Outcomes

Exclusive 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random numbers.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Not described.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

82% follow‐up at 18 months. Reasons for loss were explained and were balanced across groups.

Selective reporting (reporting bias)

Low risk

Not apparent.

Other bias

Low risk

Groups appeared similar at baseline.

Methods

Primary care facilities. Recruitment over 5 months, n = 169.

Participants

3 hospitals in the city of Pelotas, in southern Brazil. Background rates of breastfeeding initiation: high. Ethnic composition not described. Inclusion criteria: term healthy baby, family income at least US $500 per month (no economic constraints to baby's growth), mother intends to breastfeed and does not smoke. Baseline prevalence of breastfeeding in Brazil in the first 30 days = 88%.

Interventions

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

Intervention: hospital visit, home visits at 5, 15, 30, 45, 90 and 120 days, and 24 hour 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.

Outcomes

Breastfeeding pattern and duration up to age 4 months. Breastmilk intake for a subgroup of 68 infants at 4 months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated code.

Allocation concealment (selection bias)

Low risk

Sealed envelopes.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

It was stated that different field‐workers delivered the intervention and collected outcome data; but it was not clear whether this attempt at blinding was successful.

Incomplete outcome data (attrition bias)
All outcomes

High risk

188 women were randomised. 21 were excluded after 2 weeks as they had introduced formula. A further 26 withdrew (some data were available for some of these women). 141 women completed the trial (75%).

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Excluding 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).

Methods

RCT, 2 arms with individual randomisation.

Participants

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

Inclusion criteria: age 18 years or older; gestational age less than 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: Mothers ‐ medical conditions such as diabetes or hypertension; drug use that could impair breastfeeding. Infants ‐ preterm, low birthweight (< 2500 g) baby, any complications requiring admission to special care, Apgar score < 7 at 1 and 5 minutes.

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

Age: intervention 68%; control 66%; Married/cohabiting: intervention 40%; control 26%; Hispanic race: intervention 81%; control 64%; Education < high school: intervention 31%; control 38%; Received welfare: intervention 31%; control 38%; Primiparous: intervention 92%; control 89%; Planned breastfeeding duration:‐ Less than 6 months: intervention 20%; control 46%; 6‐12 months or longer: intervention 80%; control 54%.

Interventions

Control group 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 lactation specialist. Usual inpatient care and support for breastfeeding was provided by hospital staff.

Intervention group received in addition 3 prenatal home visits, daily in‐hospital visits and 9 postpartum home visits from peer counsellors, scheduled 3 in first week, 2 in second week and 1 in each week 3‐6. Women could also phone peer counsellors. Peer counsellors were mothers from the area with experience of successful breastfeeding and training from lactation consultant.

Outcomes

Infant 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 hours, over the past week and since the birth (ever given).

Notes

We have not included data from this study in the review due to high levels of attrition (> 25% loss to follow‐up).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

SPSS software was used to randomly assign subjects to study groups.

Allocation concealment (selection bias)

Low risk

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

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Blinding not attempted, women, staff and outcome assessors were likely to have been aware of group assignments.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

182 women were recruited and randomised. 162 were still eligible at delivery and 135 completed the trial (84% of those still eligible at delivery and 74% of the total randomised).

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Groups appeared similar at baseline although women in the control group were more likely (46%) to plan to breastfeed for less than 6 months than women in the intervention group (20.4%). This difference in breastfeeding intentions mean that results are more difficult to interpret.

Methods

RCT 2‐arm trial. Single‐site study, 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 less than twice the minimum Brazilian wage; hospital stay less than 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

In 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.

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.

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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

High risk

The nurse collecting outcome data was not aware of previous contacts but the authors state 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 risk

900 randomised, approximately 8% lost to follow‐up in the interventions and control groups.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

No baseline imbalance apparent. Assessment of risk of bias was made from translation notes. The original paper is in Portuguese.

Methods

Randomised controlled trial, 3‐arm trial with individual randomisation.

Participants

Recruited from Maternity Teaching Hospital in Damascus, Syria. Background rates of breastfeeding initiation: High.

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

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

Participant characteristics: age not clear. Approximately 37% primiparous, 90% had normal labour, more than 99% of the women 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

Control group received standard care in Syria (no postnatal visits).

Intervention group 1 (301 randomised): 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 group 2 (301 randomised) a single postnatal visit from a trained midwife at 3 days which included advice and education on breastfeeding.

Outcomes

Primary outcomes: 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, namely exclusive breastfeeding during the first 4 months of life.

Secondary outcomes: women’s perceptions of their health, impressions about the home visit and perceptions of its quality.

Notes

Some 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants were randomised 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 risk

Numbered, opaque and sealed envelopes..”  Group allocation was carried out by a senior midwife not involved in the rest of the study.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Participants and caregivers were not blinded. For outcome assessors it states that the 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 risk

903 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: Group A (285 women); Group B (294 women) and Group C (297 women). Incomplete data were addressed.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Some 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 will have discussed this and maybe it was recorded at the time it occurred, women in the control group will 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.

Methods

Cluster‐randomised study with 8 sites, n = 1115.

Participants

8 village communities located 3‐5 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. Baseline breastfeeding prevalence stated to be high.

Interventions

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.

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, monthly home visits, immunisation clinics and neighbourhood meetings.

Outcomes

Feeding at 3 months.
Anthropometry and diarrhoea prevalence at 3 and 6 months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Communities were paired on the basis of similar scores for socio‐economic, mortality and morbidity indicators. 1 of each pair was allocated to the intervention using a random numbers table. 8 areas randomised (4 to each condition).

Allocation concealment (selection bias)

Low risk

Statistician independent of project carried out randomisation.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Women, staff and outcome assessors all aware of intervention.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Reasons 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Areas were paired but it was not clear whether or not this achieved similar baseline characteristics between groups. Results were reported to have been adjusted for clustering.

Methods

RCT, 2 arms randomised, individual randomisation (although the study also included a non‐randomised comparison group).

Participants

100 breastfeeding mothers randomised; 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 less than 5, twins, women having operative deliveries, women who did not speak English.

Interventions

Women in both groups received a pamphlet on breastfeeding. Women in the control group received usual care (not specified).

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 minutes and were described as friendly. Women received up to 3 calls up to 6 weeks postpartum. Calls ceased when women discontinued breastfeeding.

Outcomes

Interviews at 6 weeks postpartum. Women were asked about infant behaviour and infant feeding and breastfeeding duration.

Notes

We 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 randomised 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 standard deviations 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Unclear risk

Described as “randomly assigned”.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

The interviewer who recruited women also carried out the intervention. The 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 risk

Rates of follow‐up at 6 weeks were high (97%). However, denominators for breastfeeding duration results were not reported.

Selective reporting (reporting bias)

Unclear risk

Most results were not reported by randomisation group and are difficult to interpret.

Other bias

Unclear risk

Unclear ‐ no baseline characteristics table for randomised groups.

Methods

RCT, 2‐arm trial, n = 382 women randomised.

Participants

From 2 prenatal care centres in the Bronx, New York (reported to be the US county with the highest poverty rate). Background rates of breastfeeding initiation: Low.

Inclusion criteria: speaks 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

Control group (194 randomised): Women in the control group had no contact with the lactation consultant. 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 coordinator.

Intervention group (188 randomised). The intervention was by a trained lactation consultant. Women recruited before they were 24 weeks pregnant had 2 prenatal lactation consultant 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.

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 there were various “intensities” of breastfeeding (e.g. more than 50% breast milk). This means results are complicated and not easy to interpret. Women were followed up to 12 months and detailed (graphical) weekly data are reported for weeks 1‐26 postpartum.

Notes

Results estimated from graphs.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“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 risk

Sealed envelopes, numbered and opened sequentially.

Blinding (performance bias and detection bias)
outcome assessors

High risk

“Neither the RA [research assistant] collecting breastfeeding outcome data nor the LC [lactation consultant] providing the intervention were blind with respect to treatment group.”

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Women were recruited in the antenatal period. 382 women were randomised.  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 randomised).  There was further missing data for longer term follow‐up. Loss to follow‐up was balanced across groups.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

The intervention did not appear to be standardised and many women in the intervention group (36%) did not receive any postnatal visits.

Methods

Single‐site study. Duration not stated, n = 115. RCT. 2‐arm trial with individual randomisation.

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 longer than 72 hours. 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

Control group were offered optional prenatal breastfeeding classes, postpartum breastfeeding instruction by nurses and physicians and out‐patient follow‐up by nurses and physicians in the paediatric ambulatory department.

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

Outcomes

Rates of breastfeeding at 2 months and median duration of breastfeeding.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Sample stratified by age with block randomisation in blocks of 8.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Outcome assessment not independent of intervention. Outcome data were collected by questionnaire administered by the lactation consultant who was not blind to group allocation.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Follow‐up 94%. It appeared that 115 women were randomised. It was stated that 7 in  the intervention 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Potential 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 lactation consultant excluded); intervention included input by staff caring for both intervention and control groups.

Methods

RCT, 2‐arm trial with individual randomisation (n = 339) with add‐on qualitative study.

Participants

Denver, USA; a clinic providing care for a predominantly Hispanic, medically underserved population. Background rates of breastfeeding initiation: Low.

Inclusion criteria: women aged 18 years or older, 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 longer than 72 hours following vaginal births or longer than 96 hours following caesarean section, baby with medical problems, admitted to NICU or had a hospital stay longer than 72 hours.

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

Interventions

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.

Intervention: telephone support daily, 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.

Outcomes

Any breastfeeding or predominantly breastfeeding. Maternal satisfaction, healthcare utilisation, reasons for stopping breastfeeding.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated block random allocation.

Allocation concealment (selection bias)

Low risk

Sequentially numbered opaque sealed envelopes.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

No blinding for participants or caregivers and not described for outcome assessors.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

341 women were randomised. At 1 month there 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Groups appeared similar at baseline.

Methods

Study methods were not clear. This appeared to be a cluster‐randomised trial in 35 clinics.The intervention was carried out with healthcare workers. Results are 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 (unclear). Follow‐up for 12 months.

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

Approximately 20% under 20 years, 38% primiparous, 27% vaginal deliveries, 90% more than 4 years education. 

Interventions

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

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

Outcomes

Number of exclusive breastfeeding days; survival curves.

Notes

We have not included data from this study. Data were not reported in a way in which we could incorporate results into the review. Authors report 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Method 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 risk

Not described; 20 intervention clinics and 15 control (not clear).

Blinding (performance bias and detection bias)
outcome assessors

High risk

Clinics assigned to intervention and control (blinding not attempted?).

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Data extraction from translation (original paper in Portuguese). Cluster trial with no apparent adjustment for design effect

Methods

RCT 2‐arm trial. Individual randomisation (n = 219). Recruitment July 2000‐August 2002 at an urban US hospital with BFI accreditation.

Participants

Urban US hospital prenatal clinic serving a low‐income, predominantly Latina population. Background rates of breastfeeding initiation: Low.

Antenatal inclusion criteria: low‐income women at least 18 years old, at 26 weeks' gestation or less, 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. 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

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

Intervention: 1 prenatal home visit, daily visits during postpartum hospitalisation, home visit within 24 hours and at least 2 more home visits as requested, and telephone/pager contact. Intervention from peer counsellors with 30 hours classroom training that covered LLLI Peer Counseling Program and Hispanic Health Council's curriculae. 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 hour per month continuing education and were paid for their work.

Outcomes

Breastfeeding rates at birth and 1, 3 and 6 months postpartum.
Subgroups most responsive to breastfeeding peer counselling.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

By computer programme.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

It was not stated whether there was any attempt to blind outcome assessors.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Loss to follow‐up appeared reasonably balanced although there was more loss from the control group. Reasons for loss to follow‐up stated. 219 were randomised, 72% followed up at 1 month, 70% at 3 months and 66% at 6 months.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Groups appeared similar at baseline. It was reported that many women in the intervention group received less than half of the planned visits.

Methods

Quasi‐randomised trial with sequential allocation to 3 study groups.

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

Control: usual care.

Phone support intervention: 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.

Home visits intervention: same schedule as phone support group with visits at home by the maternity nurse.

Outcomes

Breastfeeding duration and analysis of factors affecting duration of breastfeeding.

Notes

We 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 2011 for meta‐analysis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Sequentially to 1 of 3 groups.

Allocation concealment (selection bias)

High risk

In sequence (could be anticipated and changed by the person carrying out randomisation).

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Not discussed.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not clear. 180 women were followed up. It was not clear whether this number was randomised.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Baseline characteristics of 3 groups similar.

Methods

RCT, 2‐arm trial with individual randomisation

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 income lower than the minimum wage; 33% did not have access to a flush toilet, approximately 35% of the mothers were less than 20 years, 39% primiparous, approximately 28% CS.

Interventions

Maternity staff in both hospitals received (90%) the 18h 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.

In addition, women in the intervention group received ten postnatal home visits (mean duration 30 minutes); 4 during the first month, 2 during the second month and 1 per month during the 3rd to 6th 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 they 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.

Outcomes

The main outcome is 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 was also recorded at each time point.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomised 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 risk

Concealment was achieved by drawing numbers from envelopes at the time of assignment.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Data were collected in the trial by 4 researchers who were not aware of group allocation and were unconnected with the delivery of the interventions. 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. For participants they were not blinded and they did not formally assess whether masking was maintained. For those delivering the intervention (caregivers), they would be aware of group assignment. For the outcome assessors, they were described as blinded but not clear if blinding was effective.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

350 women were randomised, 175 in each group. 20 women (6%) were lost to follow‐up.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

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

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

Methods

RCT (methods not clear) 2 arm trial with individual randomisation.

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 equal or greater than 2500 g. Exclusion criteria: mother‐infant pairs that were unable to stay together due to a health concern in either the mother or infant.

Mothers 20 years old or more 76%, vaginal delivery 72%, white mothers 70%, more than 8 years education 64%, living with partner 83%.

Interventions

Control: standard hospital care met Baby‐Friendly standards. The control group appear not to have received home visits.

Intervention: In hospital, 2 nurses reinforced the orientation about breastfeeding technique routinely given to mothers, following the WHO breastfeeding counselling principles, in a 30‐minute 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. The intervention group 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.

Outcomes

The primary outcome is the number of mothers who breastfed and exclusively breastfed on maternity ward and at 30 days. The secondary outcome is the frequency of breastfeeding related problems.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Following 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 calculated 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 risk

By 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 (performance bias and detection bias)
outcome assessors

Unclear risk

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”. Not clear if blinding was effective.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

233 women were eligible, 211 followed up. (It was not clear how many were randomised.)

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear 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.

Methods

Single‐site study recruiting over 10 months, n = 258. RCT, 2‐arm trial with individual randomisation.

Participants

Women at home in Toronto, Canada. Background rates of breastfeeding initiation: Intermediate. Inclusion criteria: English speaking; primiparous; 16 years or over; single full‐term baby. Intending to breastfeed. Predominantly educated, Caucasian and over 25 years with income over $40,000/year.
Baseline prevalence: breastfeeding initiation 79%; 35% exclusive breastfeeding at 4 months.

Interventions

Control: not described

Intervention: telephone support by briefly‐trained volunteers (2.5 hour session) who had personal breastfeeding experience for at least 6 months. First contact within 48 hours 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.

Outcomes

Breastfeeding (any or exclusive) at 1, 2 and 3 months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomly generated numbers were provided by a statistician who was not involved in the recruitment process.

Allocation concealment (selection bias)

Low risk

Consecutively numbered, sealed opaque envelopes.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

“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.” Not clear if attempted blinding of outcome assessor was successful.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Very little loss to follow‐up. 258 women randomised and 2 women lost to follow‐up

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Low risk

No apparent differences between groups at baseline.

Methods

RCT, 2 arms 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 weight > 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 hours, 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 Medicaid HMO, more than 80% were first time mothers and gave birth vaginally.

Interventions

Usual care included access to paediatric care providers and hospital lactation consultants.The control group did not receive telephone peer support.

Intervention group: telephone support from trained peer supporters (teen mothers who had breastfed for more than 4 weeks). Peer supporters telephoned the new teen mothers at 2, 4, 7 days and 2, 3, 4 and 5 weeks post discharge. 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.

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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random numbers.

Allocation concealment (selection bias)

Low risk

“The assignment was recorded in a sealed and numbered envelope. Envelopes were sequentially opened.”

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Blinding attempted but not clear if it was successful.

Participants: “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.”

Outcome assessor: “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 randomised (38 intervention, 40 control).

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

In intervention group‐ 6 dropouts before first interview; 3 dropouts before 8‐week interview; 7 dropouts between 8 and 37 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear 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 collection 1996‐7.

Methods

RCT 2‐arm trial. Women randomised. 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

Control: standard care (not described).

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.

Outcomes

Any breastfeeding up to 60 days.

Notes

Extra information about reported numbers requested and received from author.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Sample was stratified "for age and parity, and finally randomly assigned to either the intervention or control group".

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Outcome assessment not blinded.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

605 women randomised. 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 less than 75% so only outcomes up to 60 days are included in this review. Reasons for drop‐out reported by group.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Baseline characteristics similar and no apparent differences between those who refused intervention and those who received it, see Table 1.

Methods

Longitudinal study. 2 arms. Cluster‐randomised trial. 10 Swedish municipalities randomised.

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 approx 27 years, married 61‐69%, vaginal delivery 70‐75%, university educated 36%.

Interventions

Control group: offered standard family classes, usually discontinued at birth.

Intervention group: 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.

Outcomes

Maternal perceptions of the relationship with the infant, maternal feelings for the infant and duration of exclusive/any breastfeeding.

Notes

10 centres randomised. 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 which data were collected at the same time as from the intervention group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The 10 largest municipalities were classified in pairs that were similar in size and had similar figures of breastfeeding duration. The municipalities were randomised pair wise to either an intervention or control group.

Allocation concealment (selection bias)

Unclear risk

Does not say.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Does not appear to be any blinding.

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 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

There was no baseline imbalance apparent, although duration of exclusive breastfeeding was presented as a baseline characteristic.

Methods

Study design: RCT. 2‐arm trial with individual randomisation.

Participants

Setting not clear: women expecting to give birth in an urban maternity unit, Canada. 120 women recruited in late pregnancy. 

Interventions

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

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. 

Outcomes

Exclusive breastfeeding at 1 and 3 months and any breastfeeding at 3 and 6 months.

Notes

We 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 are difficult to interpret.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Unclear risk

Described as “randomly assigned”.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Not discussed.

Incomplete outcome data (attrition bias)
All outcomes

High risk

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 are difficult to interpret.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Other bias: there was very little information on study methods and most of the results in the paper are not reported by randomisation group.

Methods

Single‐site RCT (n = 343) recruiting over 17 months. (4‐arm trial with factorial design).

Participants

Urban USA: in‐patient maternity unit. Background rates of breastfeeding initiation: Low.

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

Participant characteristics: 57% primiparous. Ethnic composition: black 65%, Hispanic 19%, white 13%, other 4%. Socio‐economic status defined by: < 100% poverty level ‐ 69%; 100%‐200% poverty level ‐ 21%; > 200% poverty level ‐ 10%. Mean age of participants 25.7 years.

Interventions

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.

Intervention:

(1) Postpartum breastfeeding counselling in hospital by trained counsellor (20‐40 minutes) and by telephone at 5, 7, 14, 21, 28, days and 6, 8 and 12 weeks. 24 hour advice by pager.
(2) Research discharge pack in English and Spanish.

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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomised block design (block size 8) with computer‐generated list of random numbers.

Allocation concealment (selection bias)

Low risk

Sequentially numbered opaque sealed envelopes.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

For follow‐up at 4 months it was stated that the investigator was not aware of group assignment; however, it was not clear whether outcome assessment blinding was effective (outcome assessment by telephone interview).

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 analysed 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 risk

We did not have access to the trial registration or protocol.

Other bias

Low risk

No baseline imbalance apparent.

Methods

Single‐site study recruiting over 7 months, n = 134.

Participants

Urban Iran. Background rates of breastfeeding initiation: High. Inclusion: Women without breastfeeding experience or chronic disease giving birth normally at term to a healthy baby 2.5 kg or over.

Interventions

Control: standard care not described.

Intervention: nutritionist trained using WHO Breastfeeding Counseling training course (40 hours). Contact in hospital immediately after birth, between 10 and 15 days, after 30 days and monthly to the 4th month at home or in a lactation clinic.

Outcomes

Exclusive breastfeeding at 1, 2, 3 and 4 months. Mean number of days illness with diarrhoea.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Allocation by day of the week of birth.

Allocation concealment (selection bias)

High risk

Allocation could be anticipated in advance and different days of the week may have had different characteristics (e.g. staff on duty).

Blinding (performance bias and detection bias)
outcome assessors

High risk

Women were not told directly which group they had been assigned to but would be aware of whether or not they had received the intervention. It was not stated whether or not there was any attempt to blind outcome assessment.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

134 randomised and 120 followed up.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Low risk

No baseline imbalance apparent.

Methods

RCT with individual randomisation. 2‐arm trial, n = 586, 292 assigned to intervention group and 294 to control group.

Participants

Study conducted at a University teaching hospital and affiliated community health centres. Recruitment January 1997‐September 1998 Urban Quebec, Canada. Background rates of breastfeeding initiation: Intermediate.

Inclusion criteria: mothers participating in hospital short‐stay programme. Ethnic and socio‐economic composition of sample not reported. Baseline prevalence of breastfeeding initiation in Canada (excluding territories) 1994‐5 = 73%.

Interventions

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

Intervention: Home visit from community nurse 3‐4 days postpartum. Nurses were Baccalaureate prepared, had minimum 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.

Outcomes

Breastfeeding frequency and infant weight gain assessed at 2 weeks postpartum.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Block randomisation (block size 8) stratified by parity, by computer‐generated random numbers.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

It 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 risk

586 randomised. 21 protocol deviations but analysis 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 risk

We did not have access to the trial registration or protocol.

Other bias

Low risk

Groups described as similar at baseline.

Methods

RCT 2‐arm trial with individual randomisation. Study conducted in 32 general practices in the UK. Recruitment April 1995‐August 1998, n = 720, 363 assigned to intervention group and 357 to control group.

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. 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. Socio‐economic 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

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

Intervention: women were allocated to receive 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.

Outcomes

Prevalence 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Permuted block design stratified by GP practice and parity, randomisation schedule prepared by statistician.

Allocation concealment (selection bias)

Low risk

Numbered sealed envelopes.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Reported that responses to follow‐up questionnaires were coded by blind assessors.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

720 women recruited and randomised. 97% available for follow‐up at birth, 93% at 6 weeks and 86% at 4 months.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Groups 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.

Methods

Cluster‐randomised trial. 4 clinics were “randomly assigned" to 4 different conditions.

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 motivational video (encouraging breastfeeding) playing repetitively 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‐hour 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.

Outcomes

Infant feeding method at 8 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 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 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 represent 37% of the original randomised sample. It was not clear whether loss was similar in the 4 clinics.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Cluster trial. 4 clinics;  method of randomisation not described.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Not attempted. Randomisation at clinic level may have reduced contamination.

Incomplete outcome data (attrition bias)
All outcomes

High risk

548 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 represent 37% of the original randomised sample. It was not clear whether  loss was similar in the 4 clinics.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Baseline characteristics imbalance for educational status, employment and parity ‐ although these were adjusted for in the analysis.

Methods

Quasi‐RCT, 2‐arm trial with individual randomisation. Single‐site study recruiting over 10 months, n = 97. Follow‐up 90%. Quasi‐randomised (coin toss with women sharing same room allocated by the same toss).

Participants

Urban USA ‐ in‐patient 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 25.4 years.

Interventions

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

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

Outcomes

Rates of breastfeeding at 6 weeks and 3 and 6 months. Median duration of breastfeeding.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Coin toss at the point of randomisation.

Allocation concealment (selection bias)

High risk

Coin 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 (performance bias and detection bias)
outcome assessors

High risk

Some data were derived from medical records but telephone outcome assessment not blinded.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

97 women randomised, 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Groups appeared similar at baseline.

Methods

Community‐based cluster‐randomised study (40 adjacent areas randomised). Recruitment over 10 months, n = 726.

Participants

Dakka, Bangladesh. Background rates of breastfeeding initiation: High. Mainly lower‐middle and low socio‐economic status. Women aged 16‐35 with 3 children or fewer (or 6 pregnancies or fewer) and no serious illness. Multiple births; children with congenital abnormalities, and those weighing less than 1800 g were excluded. National baseline prevalence reported in paper to be similar to control group rates. UNICEF quotes higher rates ‐ 53% exclusive breastfeeding at 0‐3 months.

Interventions

Peer counselling by women with personal breastfeeding experience trained over 40 hours 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 minutes.

Outcomes

Exclusive breastfeeding at birth, 4 days, 4 weeks, 2, 3, 4 and 5 months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Random number tables.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Women and counsellors aware of group assignment and interviewers collecting outcome data would also be aware of assignment.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

40 areas randomised (20 intervention, 20 control) 726 women randomised. 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 risk

We did not have access to the trial registration or protocol.

Other bias

Low risk

No differences in baseline characteristics apparent. Staed that results were based on individual level analysis but with adjustment for cluster level of randomisation.

Methods

Study design: RCT with 3 arms

Participants

49 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.

Interventions

3 groups.

Control: 18 randomised 12 followed up (not clear).

Intervention group 1: 15 randomised 13 followed up (not clear): usual care plus an educational session.

Intervention group 2: 16 randomised 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). 

Outcomes

Unclear. Breastfeeding at 6 weeks and breastfeeding problems.

Notes

We 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 on breastfeeding duration was approximate. “Approximately 50% of the control group and 50% of the group which received the teaching unit were still nursing at six weeks. Of the group who received the teaching plus support 80% were still nursing at 6 weeks.” 

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Unclear risk

Described as “randomly assigned”.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

No blinding although outcome assessment was not by the same nurse as the 1 delivering the intervention.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

There was high attrition in this small study. More than 30% of the control group were lost to follow‐up and results were therefore difficult to interpret.

Selective reporting (reporting bias)

Unclear risk

Most results were not reported by randomisation group.

Other bias

Unclear risk

No baseline characteristics reported.

Methods

Cluster‐RCT with prospective mixed method embedded case studies to evaluate implementation processes; 2 arms. 14 localities randomised; recruitment 2002‐4.

Participants

Setting: women registered at GP practices in 14 localities (of 66) in Scotland. Background rates of breastfeeding initiation: Low. In Scotland, only 44% of babies received any breast milk at 6 weeks in 2005.

Clusters randomised n = 14, birth records supplying data 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

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

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

Outcomes

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

Secondary outcomes: 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.

Notes

When 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; c) that used routinely collected locality‐level outcome data.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Cluster‐RCT; 14 localities randomised. 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 “An independent statistician used random number tables to randomise locality pairs to either intervention or control”. 

Allocation concealment (selection bias)

Low risk

Researchers analysing primary and secondary outcomes were blind to allocation, ensured by coding of localities.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Cluster‐randomised trial so women may not have been aware of the study although they would be aware of the intervention. Researchers analysing primary and secondary outcomes were reported to be blinded.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

According 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 for women 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 available for approximately a quarter of children).

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Analysis 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

Methods

RCT with 2 arms, n = 522 women randomised.

Participants

A large metropolitan hospital in Houston, Texas, USA, serving predominantly immigrant Hispanic women (85% monolingual Hispanic). Background rates of breastfeeding initiation 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 hours old, jaundice within 24 hours of birth, Rh‐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, control group 27.1; 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

Control group: 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.

Intervention group: mothers were given an appointment to visit the hospital‐based breastfeeding clinic at 3 to 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.

Outcomes

Primary outcome: exclusive breastfeeding at 1 month. Secondary outcomes: volume of formula given by mothers who were mixed feeding and incidence of breastfeeding problems.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Generated by random number table.

Allocation concealment (selection bias)

Low risk

After 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 (performance bias and detection bias)
outcome assessors

Unclear risk

Participants were not blinded as the envelope was opened by the mother. Caregivers were also not blinded. For 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 risk

522 randomised (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 risk

We did not have access to the trial registration or protocol.

Other bias

Low risk

There were slight baseline differences between control group and 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).

Methods

Quasi‐randomised trial. Recruitment location/duration not stated, n = 38.

Participants

UK white, working‐class women 19‐32 years, living with partner and intending to breastfeed. Background rates of breastfeeding initiation: Intermediate: prevalence of breastfeeding 1985 = 64% at birth and 26% at 4 months.

Interventions

Control: 1 antenatal home visit and 1 postnatal hospital visit.

Intervention: 3 antenatal home visits/1 hospital visit/1 'immediate' home visit and 1 or 2 further home visits 'in the early weeks'; face‐to‐face and telephone support by single lay supporter (mother/previous breastfeeding experience). No indication of training.

Outcomes

Breastfeeding at 3 months. Partial breastfeeding grouped with formula feeding as 'breastfeeding failure'.

Notes

Moderate‐to‐high risk of bias.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Alternate.

Allocation concealment (selection bias)

High risk

Alternate allocation.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Not attempted.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

38 women included. It appeared that all were followed up.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Very little information on study methods.

Methods

Quasi‐randomised trial, individual randomisation. Single‐site study. Recruitment period 18 months, n = 678.

Participants

UK ‐ maternity department of 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. Socio‐economic status defined by UK census categories (I and II 22%, III 46%, IV and V 13%).

Interventions

Control: not specified.

Intervention: individual support and problem solving by lactation nurse in hospital and at home. Duration of the intervention not specified.

Outcomes

Breastfeeding rates at 4 weeks, 3, 6 and 12 months. Satisfaction with care and intention to breastfeed next pregnancy.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Alternating 2 week periods (i.e. 2 week intervention recruitment period, 2 week control recruitment period).

Allocation concealment (selection bias)

High risk

The randomisation method did not achieve balanced group size; 228 in the intervention group vs 355 controls.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Stae that 12 months follow‐up was by an independent interviewer.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

678 women randomised 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

The method of recruiting intervention and control women appeared different; possibly face‐to‐face for intervention group and records/ not clear for the control group.

Methods

Not clear; described as “case control randomized trial”. 2 arms.

Participants

Setting: Tehran, Iran; mothers and babies recruited in a Baby Friendly accredited hospital. The intervention included a programme of home visits. 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 less than 2500 g at birth were also excluded.

Interventions

Intervention: 4 postnatal home visits (not clear)

Control group: 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 report 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".

Notes

We 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding (performance bias and detection bias)
outcome assessors

High risk

No blinding of participants/professionals reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not clear. 120 women were recruited but it was not clear how many were followed up.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Does 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).

Methods

RCT (n = 140) with 2 groups, Aug 2008‐Apr 2009.

Participants

Recruitment from postnatal wards of 2 hospitals in South Jordan. 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. Prevalence of "ever breastfed" in country: 93% (WHO Global Data Bank on Breastfeeding, accessed 12 Oct 2011). Paper states that traditionally most women initiate breastfeeding and breastfeed for up to 2 years, with 32% fully breastfeeding for more than 6 months.

Interventions

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.

Intervention group women received a 1‐hour education session approximately 2 hours 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.

Outcomes

Primary outcomes were exclusive breastfeeding at 6 months and breastfeeding knowledge. Secondary outcome was infant hospital admissions for diarrhoea and vomiting or respiratory tract infections.

Notes

Due to high levels of attrition (36%) we have not included outcome data from this study in the review.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described.

Allocation concealment (selection bias)

Low risk

Paper states randomisation occurred by women selecting 1 envelope from a group of sealed opaque envelopes.

Blinding (performance bias and detection bias)
outcome assessors

High risk

No blinding described and it appears that the same researchers that collected data also carried out recruitment and delivered the intervention.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Serious 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 risk

Not apparent.

Other bias

Unclear risk

Data 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.

Methods

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 group.

Participants

Child healthcare centres in Limbourg province, 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 80% in the Netherlands in 2002.

Interventions

Control: not specified.

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 (consultant would then contact the caregiver or mother within 24 hours of receiving the fax).

Outcomes

Exclusive and complementary breastfeeding rates at 3 months; determinants of breastfeeding at 3 months.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

By coin flip.

Allocation concealment (selection bias)

Low risk

Clusters were randomised after sites were paired for similarity of breastfeeding rates and the number of births in each centre.

Blinding (performance bias and detection bias)
outcome assessors

High risk

Oucome assessors not reported as blinded.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

20 centres were randomised. 781 women. Data available for 701 for the first follow‐up (90%) and 683 (87%) at 6 months postpartum.

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Low risk

Analyses adjusted for cluster effect by multi‐level analysis. No baseline imbalance apparent.

Methods

Multi‐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 or more at term, Apgar 5 or more at 5 minutes. Baseline breastfeeding prevalence 50% at 3 months.

Interventions

Control: staff did not receive the training.

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.

Outcomes

Any breastfeeding at 3, 6, 9 and 12 months. Incidence of respiratory, gastro‐intestinal and atopic eczema in first year.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Cluster‐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 risk

2‐stage randomisation procedure.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Clinical outcomes were recorded by staff caring for women but an audit was also carried out.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

34 sites randomised, 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear 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.

Methods

Cluster‐randomised, 2 community based trial. 22 municipalities randomised to intervention and control clusters.

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 or more.

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.

Control cluster: Health Visitors' usual practice consisting of 1 or more non‐standardised visits.

Intervention cluster: 1 to 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.

Outcomes

Duration of exclusive breastfeeding and mother’s satisfaction with breastfeeding

Notes

The 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

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

To ensure that the health visitors that were in regular contact with each other were randomised to the same breastfeeding procedure the 22 municipalities were chosen as clusters. The 22 clusters were stratified according to their number of births the year before the trial, and within 3 strata, 11 municipalities were randomised 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 risk

As for the sequence generation.

Blinding (performance bias and detection bias)
outcome assessors

Unclear risk

Participants and caregivers were not blinded. Outcome assessors were blinded‐ the identity of the health visitors was blinded to the investigators. It was not clear whether this partial blinding was effective.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

22 municipalities were randomised. 2186 women had babies during the study time period. 1760 women followed up (figure showing trial attrition not printed out with paper – to check).

Selective reporting (reporting bias)

Unclear risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

Reported that there were no significant differences between groups at baseline.

This was a cluster‐randomised trial and authors state 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 is provided which the authors say indicate that cluster effect was small. It was not clear that cluster design effect was taken into account in any of the analyses.

Methods

RCT, 2 arms with individual randomisation. Recruitment: October 2001 to May 2002.

Participants

Setting: the maternity section at the Chambery Teaching hospital in Chambery, France. Background rates of breastfeeding initiation: Intermediate. In the study hospital, breastfeeding prevalence rates were 70.8% in hospital and 58.1% at 1 month of infant age.

Participants randomised = 231.

Inclusion criteria: mothers of healthy singleton infants (gestational age: > 37 completed weeks), breastfeeding on the day of discharge and consented to participate in the study.

Exclusion criteria: infants admitted to neonatal unit, mothers transferred to intensive care unit, 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 (4.1); control: 29.7 (4.8); education more than high school graduate: 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

Control group (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 post discharge 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.

Intervention group (n = 116): in addition to standard care, mothers were invited to an outpatient visit in a primary care physician’s office within 2 weeks after the birth to see a primary care doctor who had received special breastfeeding education. Topics covered at this visit 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.

Outcomes

The primary outcome was exclusive breastfeeding at 4 weeks. Exclusive breastfeeding was defined as giving maternal milk as the only food source, with no other liquids or foods. The secondary outcomes were any breastfeeding at 4 weeks, median duration of breastfeeding, breastfeeding difficulties and maternal satisfaction with the infant feeding experience.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The 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 risk

The randomisation assignments were unknown to any of the investigators and were concealed in consecutively numbered, sealed, opaque envelopes.

Blinding (performance bias and detection bias)
outcome assessors

High risk

No blinding. The trial was described as open, although questionnaires to mothers were used to reduce the risk of observer bias, and reduce outcome assessment bias.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

(1080 women assessed for eligibility, 849 deemed not eligible). 231 women randomised, outcome data were available for all but 5 of the woman randomised, 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 risk

We did not have access to the trial registration or protocol.

Other bias

Unclear risk

The majority of women assessed were not eligible for inclusion in this trial and so the results may not be generalisable.

Methods

Participants recruited from 8 public health maternity units. Duration of recruitment 6 months, n = 1003. RCT 2‐arm trial with individual randomisation.

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.

Interventions

Peer counsellor home visits lasting 30‐40 minutes at 5, 15, 30, 60, 90 and 120 days. Counsellors 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 hours). Paid $4 per visit. Each counsellor supported 25 mothers.

Outcomes

Rates of exclusive, predominant, partial and artificial feeding at 4 months.

Notes