Methods

4‐arm randomised controlled trial to determine the effect of artificial teats on breastfeeding. Postnatal interventions while preterm infants were in hospital. Breastfeeding education and support was provided to staff.

Participants

Setting: Australia, 2 tertiary referral hospitals.

Recruitment: April 1996‐November 1999.

Inclusion criteria: women with singleton or twin infants < 34 weeks’ gestation who wanted to breastfeed.

Exclusion criteria: infants with congenital abnormalities precluding enteral feeding.

Interventions

Cup/no dummy n = 82.

Cup/dummy n = 69.

Bottle/no dummy n = 70.

Bottle/dummy n = 82.

“Cup or bottle feeding commenced at the discretion of the attending nurse/midwife or neonatologist and occurred when the mother was unavailable to breastfeed or when additional milk, given orally, was required after a breastfeed. Small plastic medicine cups were used as described by Lang. Infants randomised to the dummy groups had dummies available on trial entry; their use was encouraged during tube feeds and when the infant was restless. For infants who did not receive a dummy, alternate soothing methods were promoted (for example, facilitation of hand to mouth action promoting self quieting behaviour). Recruiting hospital received education, written instructions, literature, and 1‐to‐1 support. Written instructions, literature, and telephone contact were provided to participating peripheral hospitals.”

Outcomes

The primary outcomes were the proportion of infants fully breastfeeding (compared with partially and not) and the proportion receiving any breastfeeding (compared with none) on discharge home. Breastfeeding was defined as mother’s milk given by direct breastfeeding or other feeding device. Full breastfeeding meant that no other types of milk or solids were given except vitamins and minerals. Secondary outcomes included the length of hospital stay and prevalence of breastfeeding at 3 and 6 months after discharge.

Notes

This study was included because the intervention was part of a package of care and was designed to find out the effect of cups/dummies on breastfeeding. It included education and support for the hospitals and might have had an effect on the mother, but this detail was not specified. The authors were contacted about data for multiples in March 2016; mail was returned and other contact addresses unavailable (T Dowswell).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“An independent researcher developed a separate randomisation schedule for each recruiting hospital by using a random number table to select balanced blocks of varying size with stratification for gestation (<28 weeks, 28‐<34 weeks).”

Allocation concealment (selection bias)

Low risk

“Researchers determined allocation by telephoning an independent ward, available 24 hours a day, within the recruiting hospitals.”

Blinding of participants and personnel (performance bias)
All outcomes

High risk

"Participants, care providers, and researchers were not blinded to treatment allocation.”

Lack of blinding may have affected outcomes and treatment decisions.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

“Data entry and analysis were undertaken unblinded.” Lack of blinding may have affected interpretation of the data.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

All women appear to be accounted for, both in a study flow diagram and in the text. Attrition of women with multiple pregnancies is not described separately.

Selective reporting (reporting bias)

Unclear risk

This study was assessed from a published report without access to the protocol, therefore we cannot be certain whether all prespecified outcomes were reported.

Other bias

High risk

The report states that noncompliance was high: 56% of infants randomised to cup feeding had a bottle introduced, and 31% of the infants randomised to no dummy had a dummy introduced. These figures for noncompliance were not presented for multiple pregnancies. The results appear to be presented and analysed by intention‐to‐treat.

“We accounted for the dependence due to inclusion of twins by using robust variance estimates clustering on the mother.”

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

“Most maternal and neonatal characteristics were balanced between groups. There was, however, a ≥10% difference between dummy and no dummy for primiparity and number who had breastfed before and between cup and bottle for primiparity”. This possible baseline imbalance may have affected the results. Elsewhere, the study reported that primiparous women were more likely to have complied with the study protocol, and that previous breastfeeding may have influenced successful breastfeeding with this baby.

Methods

Randomised controlled trial of volunteer support from counsellors in breastfeeding.

Participants

Setting: 32 General Practitioner (GP) practices in London and south Essex, England, with mixed or deprived population.

Recruitment between April 1995 and August 1998.

Interventions

Inclusion criteria: considering breastfeeding.

Exclusion criteria: having breastfed a previous child for 6 weeks, planning to move out of area within 4 months of the birth, planning to consult a counsellor anyway, considered unsafe for home visits, or delivery before 36 weeks.

Recruitment 28‐36 weeks' gestation.

Multiples were not excluded from the study, however the number of women with multiple pregnancies who participated in the study were not reported.

Intervention group: n = 363. Counselling provided by 28 National Childbirth Trust (NCT) accredited counsellors, by women who had breastfed and had training in counselling (non‐directive approach and strengthening mothers' confidence in own abilities). Visited once before birth and offered postnatal support by phone or home visits.

Control group: n = 357, details of care not described.

Outcomes

The main outcome was the prevalence of any breastfeeding at 6 weeks. Secondary outcomes included the proportion of women giving any breast feeds, or bottle feeds at 4 months, the duration of any breastfeeding, time to introduction of bottle feeds, and satisfaction with breastfeeding at 6 weeks.

Notes

Multiples were not excluded from the study, however data were not reported separately. Authors were contacted for data about multiples in July 2016; response is still awaited (H Whitford).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation was achieved using numbered, sealed envelopes prepared by the statistical adviser from random permuted blocks and held in the study office. The sample was stratified by practice and birth order using separate sets of envelopes for mothers of first and subsequent babies.

Allocation concealment (selection bias)

Low risk

Central allocation was used using numbered sealed envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Women and counsellors were not blind to group allocation. Unclear if other staff were aware of group allocation.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

The identity of participants was held separately from the data records prepared when questionnaires were returned. Responses were coded blind to treatment allocation.

Counsellors played no part in assessing feeding outcomes, but women were aware of group allocation and outcome data were self reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Loss to follow‐up:

Intervention group: 13/363 at birth, 14/350 at 6 weeks, 26/336 at 4 months.

Control group: 17/357 at birth, 14/350 at 6 weeks, 26/336 at 4 months.

All women accounted for, but missing data could be related to true outcome.

Selective reporting (reporting bias)

Unclear risk

This study was assessed from a published report without access to the protocol, therefore we cannot be certain whether all prespecified outcomes were reported.

Other bias

Unclear risk

There were differences in the baseline characteristics of the participants. More women in the intervention group were undecided about breastfeeding.

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

Methods

2‐arm randomised controlled trial. The FEeding Support Team (FEST) trial, comparing proactive and reactive telephone support with reactive‐only telephone support for breastfeeding women living in disadvantaged areas.

Participants

Setting: Scotland. Hospital maternity unit, mix of urban and rural population.

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

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

Interventions

Experimental group: proactive and reactive telephone support (n = 35). Daily proactive phone calls for 1 week with further calls if needed up to 14 days. Women could call the team at any time for 2 weeks.

Control group: reactive calls only (n = 34). Women had support from the feeding team in hospital, and the option of reactive calls after discharge.

“All postnatal ward staff (including the FEST team) had a breastfeeding induction and completed a 2‐day Unicef accredited training programme.”

Outcomes

Any breastfeeding at 6‐8 weeks, exclusive breastfeeding at 6‐8 weeks (no other liquids except medicines within the previous 24 hours), satisfaction with breastfeeding help in hospital and at home (using a rating scale where 0 was least satisfied and 10 was most satisfied), number of days readmitted to hospital (mother or baby) and contact with health professionals following hospital discharge.

Notes

Authors were contacted for data about multiples in March 2016 and they reported that no separate data were available for multiples (H Whitford).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Women were randomised “immediately after discharge using a website randomisation sequence service set up by an independent statistician. Randomisation was stratified to ensure balance of primiparous and multiparous women across both trial arms”.

Allocation concealment (selection bias)

Low risk

A website randomisation sequence service set up by an independent statistician was used.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

“Although not informed of the randomisation outcome, women knew if they had been randomised to the proactive group as they received a phone call from the feeding team within 24h of hospital discharge”. Participants and caregivers were not blinded, and this may have influenced outcomes. It is not clear if womens' ‘usual’ caregivers knew of allocation.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

“Outcomes were collected by telephone by a researcher who was blind to randomisation and who had no other contact with study women”. However, women knew their group allocation and may have revealed this during the data collection interview.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Lost to follow‐up at 6‐8 weeks: 3/35 in the proactive group, 8/34 in the reactive group: overall 16%. Missing data could be related to the true outcome and loss to follow up was not balanced across groups.

Selective reporting (reporting bias)

Unclear risk

This study was assessed from a published report without access to the protocol, therefore we cannot be certain whether all prespecified outcomes were reported. However, the report states that "no changes to outcome measurement were made during the study".

Other bias

Unclear risk

There were differences in the baseline characteristics of the groups that may have affected the outcomes.

Women in the proactive call group were older on average, and more lived in the most disadvantaged postcode areas.

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

Methods

2‐arm non‐blind randomised controlled trial. Comparing breastfeeding support and encouragement to mothers of preterm infants.

Participants

Setting: Urban hospital in Brazil.

Inclusion criteria: preterm newborn, weighing less than 1500 g at birth.

Exclusion criteria: all situations that prevented breastfeeding due to the infant’s or the mother’s conditions: severe neurologic problems or facial malformations that made breast sucking difficult, digestive tract malformations, hospitalisation for longer than 4 months, HIV+ mother, death. Twins were included, but multiple births were excluded.

Interventions

“If the infant belonged to the intervention group, the researcher was called and stayed with the mother in the labor room”

“(T)he researcher would provide information about the infant’s conditions to the mother”

“At the mother’s hospital discharge, support was offered again and instructions about the continuation of milk production and treatment were repeated”

“When an infant of the intervention group was discharged, the researcher gave the parents a cell phone number for contact. The first meeting was scheduled one week after discharge”.

Outcomes

"Exclusive breastfeeding was defined as feeding the infant with only the mother’s milk, and breastfeeding was any situation in which the infant received the mother’s milk, regardless of whether exclusively or not."

Assessed at discharge. Follow‐up after discharge was monthly until 6 months

Notes

Authors were contacted about data for multiples in March 2016: no response was received and other contact addresses were unavailable (H Whitford).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

“(A)llocation followed the consecutive and alternate order of birth of the infants. By drawing lots, it was determined that the first infant would be assigned to the routine group”. This method appears to be alternate randomisation.

Allocation concealment (selection bias)

High risk

Allocation was not concealed if alternate.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and personnel were not blind to group allocation.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

“Data about the two groups were recorded and reviewed by the researcher; therefore, the study was not blinded”.

Incomplete outcome data (attrition bias)
All outcomes

High risk

15/51 in the routine group, 13/49 in the intervention group were excluded. The main causes were prolonged hospitalisation (32%) and death (43%); causes were similar in the 2 groups. There was no loss to follow‐up at 6 months after discharge or up to weaning in the remaining infants.

Selective reporting (reporting bias)

Unclear risk

Not clear what data were recorded.

Other bias

Unclear risk

“Mothers and infants in the two groups had similar characteristics”.

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

Methods

2‐armed randomised controlled trial "to compare office‐based care (OBC) with a care model using a home nursing visit (HNV) as the initial postdischarge encounter for “well” breastfeeding newborns and mothers".

Participants

Setting: deliveries in 1 medical centre in Pennsylvania, USA, Sept 2006‐Aug 2009.

Inclusion criteria: “Eligible newborns were singletons and twins born after at least 34 weeks’ gestation to English‐ speaking mothers attempting to breastfeed during the maternity stay and with intent to continue breastfeeding after discharge".

Exclusion criteria: "Dyads were excluded for atypical stays characterized by (1) a 2‐night or longer stay after a vaginal delivery; (2) a 4‐night stay or longer after a cesarean section; (3) a hospital course with atypical complications (e.g., ambiguous genitalia, endometritis); or (4) newborn hyperbilirubinaemia requiring phototherapy during the nursery stay.

Mothers were also excluded for major morbidities and/or preexisting conditions that would affect postpartum care, lack of a telephone number, previous study participation, residence outside the coverage region of the Visiting Nurse Association of Central Pennsylvania (VNA), or if an HNV was specifically requested by a hospital social worker or child protective services owing to social concerns".

Interventions

Randomised n = 1154.

Home nurse visits n = 576 (n = 7 twins).

Control group n = 578 (n = 8 twins).

Nurses had received additional training on supporting breastfeeding. Women also had a clinic visit 1 week after the nurse visit to check recovery after the birth and newborn weight (5‐14 days after the birth). The nurses provided information on a range of issues including safety, infant care and infant feeding.

Outcomes

Primary outcomes: maternal satisfaction with care, maternal mental health, infant morbidity, emergency room visits, and hospital admission.

Secondary outcomes: data provided by the research team on maternal satisfaction, breastfeeding outcomes (duration and exclusivity) and infant health outcomes at 2 weeks and 2 months following birth.

Notes

Authors were contacted about data for multiples in March 2016: data were received (T Dowswell).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“The computer‐generated randomization sequence included stratification for delivery type (vaginal delivery, forceps‐ or vacuum‐assisted vaginal delivery, or cesarean section)."

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Women and staff providing care could be aware of randomisation group.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

It was stated that follow‐up was by telephone interviews carried out by staff unaware of the randomisation group – it is possible women may have revealed group allocation.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

There were some missing data for questionnaires.

Selective reporting (reporting bias)

Low risk

Outcome reporting bias is unlikely. Protocol was available and all relevant outcomes appear to be reported.

Other bias

Unclear risk

Groups appeared balanced at baseline. (However, there were limited data for twin deliveries, so baseline comparability not clear for this group. Data were not adjusted for twins, rather a single outcome for each set of twin was reported.)

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

Methods

2‐arm cluster‐randomised trial, to compare home based counselling visits to usual care.

Participants

Setting: community areas of Southern Tanzania, in 2009‐2011.

Inclusion criteria: ward in 1 of the 6 districts: Newala, Randahimba, Lindi Rural, Ruangwa and Nachingwea, Mtwara Rural.

Exclusion criteria: “There were no exclusion criteria for clusters, households, or women, after randomisation”.

Interventions

Wards randomised n = 132, in 6 district study areas.

Home‐based counselling intervention to improve newborn care, in addition to routine care. Volunteers were recruited from the villages to implement the counselling intervention. They initiated the contact and provided face‐to‐face contacts in 3 visits during pregnancy, 2 in the early neonatal period, with additional visits for small babies. Volunteers were trained for 5 days by their district health teams and followed up in their villages after starting conducting home visits.

Outcomes

"Breastfed within 1 hour of birth, fed only breast milk in first 3 days."

Notes

Authors were contacted about data for multiples in March 2016: no response was received (T Dowswell).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“(I)mplicit stratification to maximise balance in intervention and comparison groups. We listed the 114 wards in order of district, division, tertile of baseline neonatal mortality, and population, splitting them into 57 pairs. We allocated the wards in each ‘pair’ to intervention or control using random numbers generated by Microsoft Excel. This is equivalent to 57 tosses of the coin”.

Allocation concealment (selection bias)

Unclear risk

Not described

Blinding of participants and personnel (performance bias)
All outcomes

High risk

“The nature of the intervention prevented blinding researchers, community members or health staff to the allocation”. This may have introduced bias in treatment decisions, and assessment of outcomes.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

The nature of the intervention prevented blinding researchers, community members or health staff to the allocation”. This may have introduced bias in the assessment of outcomes during household interviews.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

“If no household members were present at the time the interviewer visited, the household was visited again later the same day. Households were not replaced in cases of refusal or absence. Logical checks and skip patterns took place at data entry”. Difficult to tell if there were incomplete data.

Selective reporting (reporting bias)

Unclear risk

Newborn morbidity is prespecified in the protocol, but does not appear to have been reported (mortality is reported, however). Supervisors undertook quality control activities: accompanying interviewers to 3 households each day, and revisiting households where interviewers had reported either that there were no residents or they refused to participate. 2 houses were revisited daily and a small number of interview questions were repeated, to compare with the responses collected. 'Random' method of selection of houses to collect outcome measures using throw of a pen.

Other bias

High risk

Not sure if adjustment was made for clusters. Some leakage from intervention to control areas was possible.

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

Methods

3‐arm randomised trial of telephone peer counselling (low frequency contact, high frequency contact compared to usual care).

Participants

Setting: Oregon, USA.

Recruitment July 2005‐July 2007 (stopped after December 2005 in 1 Local WIC Agency (LWA) because of no peer counsellor).

Inclusion criteria: English or Spanish‐speaking women attending a new pregnancy appointment for WIC (Supplemental Nutrition Program for Women, Infants, and Children) who indicated that they intended to breastfeed or who were undecided about breastfeeding. Women were not excluded on the basis of age, multiple gestations, or previous birth history.

Exclusion criteria: none.

Interventions

4 telephone contacts (n = 646) or 8 telephone contacts (n = 645) (subsequently combined because there was no difference in the distribution of peer contacts) compared to usual care (n = 657). Contact from peers who had “breastfed at least 1 infant for a minimum of 6 months, were currently or had been a WIC client within the past 5 years, were able to devote at least 10 hours per week to peer counselling, were able to access transportation to bring them to the clinic several times per week, and were fluent in Spanish if service Spanish‐speaking clients”. Proactive contact, by telephone during pregnancy and postnatal period. Counsellors received training which was “grounded in the Loving Support curriculum, covered technical breastfeeding topics, methods of providing peer support, scope of practice, and the benefits of breastfeeding”. “Women assigned to the low‐frequency peer counselling group were scheduled to receive 4 planned, peer‐initiated contacts: the first after initial prenatal assignment, the second 2 weeks before the expected due date, and the third and 4th at 1 and 2 weeks postpartum. Women in the higher‐frequency treatment group were to receive 8 scheduled calls. The first 4 calls were the same as those in the low‐frequency treatment group and the last 4 calls were scheduled at months 1, 2, 3 and 4.”

Outcomes

Initiation, duration, and exclusivity of breastfeeding at 1, 3 and 6 months. Recorded weekly for first month, then monthly to 1 year. "Duration of exclusive and nonexclusive breastfeeding was derived from the first time that the mother reported to WIC that she had stopped breastfeeding or introduced formula and the timing of each."

Notes

Authors were contacted about data for multiples in March 2016: data were received (H Whitford).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“(C)onsent forms were sent to the state’s WIC office. The forms were sorted between Spanish‐ and English‐speaking clients, after which they were randomly allocated to 1 of 3 study arms by using a computer‐generated random number function”.

Allocation concealment (selection bias)

Low risk

Randomisation happened at a central office.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants: “participants knew how many contacts they were eligible to receive”.

Caregiver: “Peer counsellors were not blinded to the treatment status of their clients”.

This lack of blinding may have affected decisions about feeding.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessor not described.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

17 women were lost to follow‐up, 46 women lost their infant or pregnancy: 3.2% attrition (1885/1948 were retained).

Breastfeeding duration data were missing for women who reported breastfeeding and then left WIC. The percentages of unknown breastfeeding duration and exclusivity differed significantly between the 3 study arms.

Selective reporting (reporting bias)

Unclear risk

“There was no difference in the number of contacts between the high‐ and low‐frequency treatment groups for women with non‐missing data on breastfeeding outcomes. Nor did we find any difference in breastfeeding outcomes between those in the high‐ and low‐frequency treatment groups. As a result we combined the 2 peer counselling treatment arms into a single category”. This change to the prespecified method is well justified, but may have introduced bias.

Other bias

Unclear risk

Figures presented for when peer counsellors contacted women suggest that 52% were reached within 1 week after delivery, and 72% by 2 weeks. 78% of all women in the treatment group had multiple telephone contacts with a peer counsellor, with at least 1 prenatal and 1 postpartum call. This means that 28% of women had not been reached at 2 weeks postpartum, and 22% had only 1 contact (or all contact was prenatal or postnatal). This is a sizeable proportion of women who did not receive the intervention. Results appeared to be intention‐to treat. The groups of women appeared to be comparable at baseline:
“(T)here was no evidence of pretreatment covariate imbalance among women assigned to a treatment arm”.

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

Methods

3‐arm randomised trial of telephone peer counselling (low frequency contact, high frequency contact compared to usual care).

Randomised controlled trial of women in attending antenatal care at a large hospital to receive 1 of 3 support strategies from late pregnancy (32‐26 weeks) to 3 months postpartum: cell phone based peer support (CPS) or monthly peer‐led support groups (PSG) or Control

Participants

Setting: a large hospital in Kenya, Africa.

753 randomised.

Inclusion criteria: low‐income urban women (32‐36 weeks pregnant).

Exclusion criteria: none known.

Interventions

Women were randomised to community‐based continuous cell phone‐based peer support (CPS) or monthly peer‐led support groups (PSG) or Control (usual care). Trained peer leaders supported both pregnant and postpartum women randomised to CPS and PSG from late pregnancy (32‐26 weeks) to 3 months postpartum and were retrained mid intervention using FAQ of participants. (Data available for 504 women.)

Outcomes

Exclusive breastfeeding (EBF) estimated by maternal 7 day recall of use of infant foods at 3 months age by intervention group. Process evaluation results were also collected.

Notes

Authors were contacted about data for multiples in March and April 2016: no response was received (H Whitford).Only conference abstracts were available. Unable to find any published papers with full report of details. Attempted to contact authors on 3 occasions with no reply.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described, other than ‘randomised’.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants: not possible due to the interventions.

Caregiver: not possible due to the interventions.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessor not described.

Incomplete outcome data (attrition bias)
All outcomes

High risk

753 women randomised; 504 (66.6%) infants completed, including twins (Sellen 2014).

“There was no difference in dropout by baseline cell‐phone access or intervention allocation” (Mbugua 2013).

Selective reporting (reporting bias)

Unclear risk

Assessed from several abstracts, with no protocol available. Few outcomes were reported.

Other bias

Unclear risk

Full study report unavailable and assessment made on basis of abstracts only.

Supported by Bill & Melinda Gates Foundatin to FHI360, through the Alive & Thrive Small Grants Program managed by UC Davis; Global Alliance for Improved Nutrition; Canada Research Chair program award.

Methods

2‐armed randomised control trial of a prenatal paediatric home visit for urban low‐income families.

Participants

Setting: USA, urban, low‐income families.

Recruitment from February 1992 to July 1993.

Inclusion criteria: nulliparous pregnant women, 18 years or older, 8‐28 weeks gestational age, who "had not yet selected a paediatrician or wanted their infant to receive paediatric care at the hospital‐based paediatric clinic were recruited from the hospital‐based obstetrics clinic".

Exclusion criteria: "Women were excluded if they admitted to prenatal drug use or had a recognized psychiatric illness or human immunodeficiency virus infection".

Interventions

Intervention: women received an appointment by mail for a prenatal paediatric visit to occur between 32 to 36 weeks' gestation and a telephone reminder 24‐48 hours before the appointment, n = 81.

Comparison: women were not offered a prenatal paediatric visit, but received standard care, n = 75.

Both groups received a letter informing them of the paediatrician's name, and clinic brochures. Paediatricians received training in components of the prenatal paediatric visit, counselling parents of a newborn infant, and breastfeeding techniques and strategies to encourage breastfeeding initiation.

Outcomes

Breastfeeding intent, initiation and duration (at 30 and 60 days); car safety seat use; circumcision; health service use; relationship between mother and paediatrician.

Notes

"In the one instance where a mother delivered twins, only twin A infant was included in the study."

Authors were contacted about data for multiples in March 2016: no response was received (S Wallis).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

“Random number table with blocks of 10”; “block randomization was chosen to control for any variation that might occur over time in recruitment strategies or resident education”.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

No blinding of participants or caregivers was described.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No blinding of outcome assessors was described.

Incomplete outcome data (attrition bias)
All outcomes

High risk

All women were accounted for, but high attrition at 2 months may have introduced bias. “A total of 156 women enrolled in the study; 81 were randomised to the prenatal visit intervention group and 75 to the control group.” “By the time of delivery, 74 mother‐infant dyads remained in the intervention group and 70 in the control group.” (miscarriage or transferred obstetric care elsewhere) “When the infants were 2 months, 54 intervention mothers and 51 control mothers were interviewed” (mostly because of transferred care). 4.4% lost at delivery, 33% lost at 2 months.

Selective reporting (reporting bias)

Unclear risk

This study was assessed from a published report, without access to the protocol. It is therefore not possible to be certain if all prespecified outcomes were reported.

Other bias

Unclear risk

The 2 groups of women appeared to have similar baseline characteristics: “Dyads in the intervention and control group did not differ with regard to maternal age, education, type of medical coverage, week at which prenatal care was initiated, infant gestational age at birth, race, or rate of vaginal delivery”.

“The data were analysed using the “intention to treat” model. Mothers remained in the intervention group once they were randomized whether or not they made a prenatal pediatric visit”.

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).

Methods

2‐armed randomised controlled trial.

Participants

Setting: primary care in North Trent, UK.

Inclusion criteria: "All women attending hospital and general practice antenatal clinics in one locality in North Trent were invited to participate".

Exclusion criteria: none described.

Interventions

Intervention: pregnant women "were asked in the antenatal period to identify a close female confidante who could support them to breastfeed following the birth of their babies". "The midwife visited both mother and confidante together during the antenatal period to discuss breastfeeding." Most women chose their mothers as their breastfeeding supporter, n = 30.

Control: "Routine antenatal care which also included a home visit to discuss breastfeeding, although this was without a female confidante", n = 42.

Outcomes

Breastfeeding initiation and duration at birth, 10 days, 1 month, 6 weeks, 3 months and 6 months. Not specified if any or exclusive breastfeeding recorded.

Notes

Authors were contacted about data for multiples in March 2016: no response was received (S Wallis).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

“Randomised”, but no further information given.

Allocation concealment (selection bias)

Unclear risk

Not described.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants and caregivers were not blinded to the intervention.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Not described.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

The results were not recorded as raw data, so numerators and denominators were not clear. 4/30 women did not receive a home visit to discuss breastfeeding. It is unclear whether these women were subsequently included in analyses (intention‐to‐treat) or not.

Selective reporting (reporting bias)

Unclear risk

The study was assessed from a brief published report without access to the protocol. It is unclear whether all prespecified outcomes were reported.

Other bias

Unclear risk

“The breastfeeding initiation rate for women participating in the study was significantly higher than the background Trust rate”. This suggests that women taking part in the study were not representative of the population being studied.

Results for multiple pregnancies will be underpowered, as the sample size was calculated to show differences in all babies (singletons and multiples).