Which position would the nurse suggest the lactating client assume for initial feeding of the newborn?

Cochrane Database Syst Rev. 2016 Nov; 2016(11): CD001688.

Monitoring Editor: Olukunmi O Balogun,

National Center for Child Health and Development, Department of Health Policy, 2‐10‐1 Okura, Setagaya, TokyoTokyoJapan, 157‐8535

University College Dublin, School of Medicine, 65/66 Lower Mount Street, DublinIreland, 2

University of Dundee, Mother and Infant Research Unit, School of Nursing and Health Sciences, 11 Airlie Place, DundeeTaysideUK, DD1 4HJ

St. Luke's International University, Graduate School of Nursing Sciences, Global Health Nursing, 10‐1 Akashi‐cho, Chuo‐Ku, TokyoJapan, 104‐0044

University of Dundee, evidence Synthesis Training and Research Group (eSTAR), 11 Airlie Place, DundeeUK, DD1 4HJ

Cornell University, Division of Nutritional Sciences, 244 Garden Avenue, IthacaNYUSA, 14853

Abstract

Background

Despite the widely documented risks of not breastfeeding, initiation rates remain relatively low in many high‐income countries, particularly among women in lower‐income groups. In low‐ and middle‐income countries, many women do not follow World Health Organization (WHO) recommendations to initiate breastfeeding within the first hour after birth. This is an update of a Cochrane Review, first published in 2005.

Objectives

To identify and describe health promotion activities intended to increase the initiation rate of breastfeeding.

To evaluate the effectiveness of different types of breastfeeding promotion activities, in terms of changing the number of women who initiate breastfeeding.

To evaluate the effectiveness of different types of breastfeeding promotion activities, in terms of changing the number of women who initiate breastfeeding early (within one hour after birth).

Search methods

We searched Cochrane Pregnancy and Childbirth's Trials Register (29 February 2016) and scanned reference lists of all articles obtained.

Selection criteria

Randomised controlled trials (RCTs), with or without blinding, of any breastfeeding promotion intervention in any population group, except women and infants with a specific health problem.

Data collection and analysis

Two review authors independently assessed trial reports for inclusion, extracted data and assessed trial quality. Discrepancies were resolved through discussion and a third review author was involved when necessary. We contacted investigators to obtain missing information.

Main results

Twenty‐eight trials involving 107,362 women in seven countries are included in this updated review. Five studies involving 3,124 women did not contribute outcome data and we excluded them from the analyses. The methodological quality of the included trials was mixed, with significant numbers of studies at high or unclear risk of bias due to: inadequate allocation concealment (N = 20); lack of blinding of outcome assessment (N = 20); incomplete outcome data (N = 19); selective reporting (N = 22) and bias from other potential sources (N = 17).

Healthcare professional‐led breastfeeding education and support versus standard care

The studies pooled here compare professional health workers delivering breastfeeding education and support during the prenatal and postpartum periods with standard care. Interventions included promotion campaigns and counselling, and all took place in a formal setting. There was evidence from five trials involving 564 women for improved rates ofbreastfeeding initiation among women who received healthcare professional‐led breastfeeding education and support (average risk ratio (RR) 1.43, 95% confidence interval (CI) 1.07 to 1.92; Tau² = 0.07, I² = 62%, low‐quality evidence) compared to those women who received standard care. We downgraded evidence due to design limitations and heterogeneity. The outcome of early initiation of breastfeeding was not reported in the studies under this comparison.

Non‐healthcare professional‐led breastfeeding education and support versus standard care

There was evidence from eight trials of 5712 women for improved rates of breastfeeding initiation among women who received interventions from non‐healthcare professional counsellors and support groups (average RR 1.22, 95% CI 1.06 to 1.40; Tau² = 0.02, I² = 86%, low‐quality evidence) compared to women who received standard care. In three trials of 76,373 women, there was no clear difference between groups in terms of the number of women practicing early initiation of breastfeeding (average RR 1.70, 95% CI 0.98 to 2.95; Tau² = 0.18, I² = 78%, very low‐quality evidence). We downgraded the evidence for a combination of design limitations, heterogeneity and imprecision (wide confidence intervals crossing the line of no effect).

Other comparisons

Other comparisons in this review also looked at the rates of initiation of breastfeeding and there were no clear differences between groups for the following comparisons of combined healthcare professional‐led education with peer support or community educator versus standard care (2 studies, 1371 women) or attention control (1 study, 237 women), breastfeeding education using multimedia (a self‐help manual or a video) versus routine care (2 studies, 497 women); early mother‐infant contact versus standard care (2 studies, 309 women); and community‐based breastfeeding groups versus no breastfeeding groups (1 study, 18,603 women). None of these comparisons reported data on early initiation of breastfeeding.

Authors' conclusions

This review found low‐quality evidence that healthcare professional‐led breastfeeding education and non‐healthcare professional‐led counselling and peer support interventions can result in some improvements in the number of women beginning to breastfeed. The majority of the trials were conducted in the USA, among women on low incomes and who varied in ethnicity and feeding intention, thus limiting the generalisability of these results to other settings.

Future studies would ideally be conducted in a range of low‐ and high‐income settings, with data on breastfeeding rates over various timeframes, and explore the effectiveness of interventions that are initiated prior to conception or during pregnancy. These might include well‐described interventions, including health education, early and continuing mother‐infant contact, and initiatives to help mothers overcome societal barriers to breastfeeding, all with clearly defined outcome measures.

Plain language summary

Interventions for encouraging women to start breastfeeding

What is the issue?

International rates of breastfeeding initiation are extremely variable both between and within countries. Low‐ and middle‐income countries generally have high rates of women starting breastfeeding, and the challenge is for breastfeeding to begin within one hour of birth. High‐income countries have a much greater variation in the number of women who start breastfeeding, with more highly educated and more well‐off women likely to start.

The World Health Organization recommends that breastfeeding should start within the first hour after giving birth, that all infants should be exclusively breastfed from birth to six months of age, and that breastfeeding should continue until 2 years or beyond. We know that breastfeeding is good for the health of women and babies. Babies who are not fully breastfed for the first three to four months of life are more likely to suffer from infections of the stomach and intestines, air passages and lungs, or develop ear infections. Babies who are not breastfed are more likely to be overweight or have diabetes later in life, and mothers who do not breastfeed have increased risks of breast and ovarian cancer. Other practical benefits of breastfeeding include saving money on buying breast milk substitutes and, for society, on treating illness. Yet many women feed their babies with infant formula.

Why is this important?

We want to have a better understanding of what works to promote breastfeeding, for women, their families, the health system and society. Women face many barriers to breastfeeding, including lack of public spaces where women can breastfeed without feeling embarrassment; lack of flexible working days for breastfeeding women at work; widespread advertising of breast milk substitutes; and public policy that ignores the needs of breastfeeding women. New ways to promote breastfeeding are needed.

What evidence did we find?

We searched for evidence on 29 February 2016. This updated review now includes 28 randomised controlled studies involving 107,362 women. Twenty studies involving 27,865 women looked at interventions to increase the number of women who started breastfeeding, in three high‐income countries (Australia, 1 study; UK, 4 studies; and USA, 14 studies) and one lower middle‐income country (Nicaragua, 1 study). Three studies investigated the effect of an intervention to increase the number of women who started breastfeeding early, within one hour after birth. These involved 76,373 women from Malawi, Nigeria and Ghana. The study from Malawi was large, with 55,931 participants.

Health education delivered by doctors and nurses and counselling and peer support by trained volunteers improved the number of women who began breastfeeding their babies. Five studies involving 564 women reported that women who received breastfeeding education and support from doctors or nurses were more likely to start breastfeeding compared to women who received standard care. Four of these studies were conducted in low‐income or amongst minority ethnic women in the USA, where baseline breastfeeding rates are typically low. Eight studies involving 5712 women showed improved rates of starting breastfeeding with trained volunteer‐delivered interventions and support groups compared to the women who received standard care.

Breastfeeding education provided by trained volunteers could also improve the rates of early initiation of breastfeeding, within one hour of giving birth, in low‐income countries.

We assessed all the evidence in this review to be low‐quality because of limitations in study design and variations in the interventions, to whom, when, where, and how an intervention was delivered. Standard care also differed and could include some breastfeeding support, for example, in the UK.

We found too little evidence to say whether strategies with multimedia, early mother‐infant contact, or community‐based breastfeeding groups were able to improve breastfeeding initiation.

What does this mean?

Health professionals with training in breastfeeding including midwives, nurses, and doctors, and trained volunteers can deliver education sessions and provide counselling and peer support to increase the number of women who start breastfeeding their babies. High‐quality research is needed to understand which interventions are likely to be effective in different population groups. More studies are needed in low‐ and middle‐income countries to find out which strategies will encourage women to start breastfeeding just after giving birth.

Summary of findings

Background

Description of the condition

There is extensive, good‐quality evidence for short‐term and long‐term health risks of formula‐feeding. The World Health Organization (WHO) recommends initiation of breastfeeding within the first hour after birth, exclusive breastfeeding for the first six months, with continued breastfeeding along with appropriate complementary foods up to two years of age or beyond (WHO 2003). Babies who are not breastfed are more likely to suffer infectious diseases such as gastroenteritis, respiratory disease, and otitis media (middle‐ear infections) leading to increased hospitalisation, morbidity, and mortality (Bowatte 2015; Horta 2013; Sankar 2015). Children who have not been breastfed have increased rates of childhood diabetes and obesity (Horta 2015a), and increased dental disease (Peres 2015; Tham 2015). In addition, there is evidence of an adverse impact of not being breastfed on IQ, and educational and behavioural outcomes for the child (Heikkilä 2011; Heikkilä 2014; Horta 2015b; Quigley 2012). For women, good‐quality evidence shows associations between not breastfeeding and increased risks of breast and ovarian cancer, and diabetes (Chowdhury 2015). For preterm babies, a diet of exclusive breast milk reduces the incidence of necrotising enterocolitis ‐ a disease of the gastrointestinal tract of premature infants that results in inflammation and bacterial invasion of the bowel wall (Hermann 2014; Ip 2007).

Attempts have been made to quantify public cost benefits of breastfeeding. The global cost burden of not breastfeeding was estimated by Rollins 2016 to be USD 302 billion annually. In the UK, Renfrew 2012a estimated that a modest increase in breastfeeding rates could save over GBP 17 million per annum by avoiding the costs of treating four acute diseases in infants (gastrointestinal infection, lower respiratory tract infection, otitis media, and necrotising enterocolitis).

International rates of initiation of breastfeeding are extremely variable between and within countries. As data are gathered using different methods in different settings, reported rates should be treated with caution. From countries where data are available, low‐ and middle‐income countries generally have high rates of breastfeeding initiation of over 90% (Victora 2016b). However there is often a delay in initiating breastfeeding beyond the first hour after birth, which increases neonatal mortality (NEOVITA Study Group 2016). The world average for early initiation of breastfeeding is 44% (UNICEF 2014), however there is wide variation, with some countries such as India and Pakistan reporting rates of 23.3% and 18.4% respectively (Victora 2016b). In high‐income countries, there is wide variation of breastfeeding initiation. Many countries report rates of over 90% such as Australia, Chile, the Nordic countries, Italy, Japan, Russia, and Saudi Arabia (Victora 2016b); however, lower rates are reported from the UK (81%), the USA (79%), France (63%), and the Republic of Ireland (55%) (Victora 2016b). However, country‐level breastfeeding rates conceal geographical and social gradients in breastfeeding initiation. For example, in the UK, breastfeeding initiation rates range from 83% in England to 64% in Northern Ireland (McAndrew 2012). At the same time, there is a stark social‐class gradient with the highest incidence of breastfeeding in women aged over 30 years (87%), those who continued education beyond 18 years (91%), and those in managerial and professional occupations (90%) (McAndrew 2012). In the USA, the lowest rates of breastfeeding initiation are among black women (54%) (CDCP 2010).

One of the major factors contributing to low rates of breastfeeding initiation is the influence of the breast milk substitute industry. It has been estimated that the retail value of the industry will reach USD 70.6 billion by 2019 (Rollins 2016). Inadequate implementation and enforcement of The International Code of Marketing of Breast Milk Substitutes (WHO 1981) is one key factor influencing women’s decision to breastfeed, and the belief that, in spite of the evidence to the contrary, infant formula has equivalent nutritional value to breast milk (McFadden 2016). It is unclear whether the availability of subsidised infant formula milk through welfare food programmes, such as the UK‐based Healthy Start Programme and the USA‐based Special Supplemental Nutrition Program for Women, Infants, and Children, is an economic factor which contributes unintentionally to women in low‐income groups deciding to formula feed (see for example Jiang 2010).

Description of the intervention

The decision to breastfeed is influenced by multiple complex factors at the individual, family, health system, and societal levels (Dyson 2010). Consequently, there are many approaches to promoting the initiation of breastfeeding which may target pregnant women, their families, wider communities and society, or the health service. Interventions to promote the initiation of breastfeeding are delivered before the first feed, i.e. before or during pregnancy, or immediately after birth.

Interventions targeted to individual women include health education, peer support, practical skills training and early mother‐and‐baby contact. Health education interventions to promote the initiation of breastfeeding delivered during pregnancy may entail one or more sessions, be delivered to groups or one‐to‐one, in formal or informal settings, and be delivered by health professionals, maternity support workers, or peer supporters who may be trained or untrained. Breastfeeding health education may be targeted to women alone or it may include family members such as partners and parents (Grassley 2007; Ingram 2004). The content of health education to promote the initiation of breastfeeding may include the health outcomes of breastfeeding compared to formula‐feeding, what to expect when breastfeeding, and how to prevent and solve breastfeeding‐related problems. It may also include practical skills such as positioning and attachment of the baby at the breast, and the opportunity to talk to a breastfeeding woman and observe a breastfeed. There is increasing focus on health education approaches to predict and support behaviour change, such as motivational interviewing and the Theory of Planned Behaviour (see for example Copeland 2015; Lawton 2012).

Peer support interventions to promote the initiation of breastfeeding are generally targeted at communities where breastfeeding rates are low, and involve contact between a pregnant woman and a woman from a similar background who has experience of breastfeeding (Phipps 2006). This type of mother‐to‐mother support has been shown to increase breastfeeding initiation rates (Dyson 2006). Peer supporters undergo varying lengths and styles of training, can be paid or unpaid, and they can be integrated into the healthcare team or separate.

The most effective health service intervention to promote the initiation of breastfeeding is the WHO/United Nations International Children's Emergency Fund (UNICEF) Baby Friendly Hospital Initiative (BFHI), also known in some countries as the Baby Friendly Initiative (BFI). The BFHI/BFI is a multifaceted, structured programme that involves organisational change (Beake 2012). The BFHI/BFI comprises implementation of the Ten Steps to Successful Breastfeeding (WHO/UNICEF 1989), that cover policy, staff training, promotion and support of breastfeeding, limiting use of infant formula, teats and pacifiers, and keeping mothers and babies together (rooming‐in) (Pérez‐Escamilla 2016). Implementation of BFHI/BFI has increased breastfeeding initiation rates in Israel, Taiwan, UK, and USA (Beake 2012; Pérez‐Escamilla 2016).

Mass media campaigns are interventions that are targeted toward wider society, and, when implemented alongside other interventions have had some success at increasing breastfeeding initiation rates (Fairbank 2000).

How the intervention might work

Interventions to promote the initiation of breastfeeding work in different ways that are likely to be context‐specific, to vary according to individual needs and circumstances (Rollins 2016), and to vary by each country’s economic status and breastfeeding rates. Successful interventions work through addressing the many structural, societal, economic, and individual influences on the decision to breastfeed (Rollins 2016). These include increasing women’s motivation to breastfeed, whether that be via providing information about the health outcomes of breastfeeding, providing women with the skills and confidence to commence breastfeeding, or using more structured approaches such as motivational interviewing that seek to ‘increase an individual’s belief that they can achieve a desired outcome’ (Copeland 2015). Interventions that focus on women’s families and wider communities attempt to change societal perceptions and norms regarding infant‐feeding (Rollins 2016), reducing the impact of these barriers. These types of interventions are particularly important in communities where breastfeeding rates are low and there is an entrenched infant formula‐feeding culture. Structured programmes such as BFHI/BFI work through addressing many of the negative influences on women’s infant‐feeding decisions that derive from health service policy and the knowledge, skills, and attitudes of health personnel (Rollins 2016). Not least of these is protecting women and staff from the influence of marketing and promotion of breast milk substitutes (Piwoz 2015).

Why it is important to do this review

The purpose of this review is to examine interventions which aim to encourage women to breastfeed, to evaluate their effectiveness in terms of changes in the number of women who initiate breastfeeding, and in terms of changing the number of women who initiate breastfeeding early (within one hour after birth). It is important to do this review to inform the design of interventions to promote the initiation of breastfeeding. Increasing rates of initiation of breastfeeding is the first step towards meeting WHO recommendations for breastfeeding and realising the potential of breastfeeding in improving health, reducing the economic burden of ill health, and reducing health inequalities. It is also important to undertake this review to find effective interventions to counter the promotion of breast milk substitutes by the infant formula industry. The amount of money invested by formula manufacturers is many times greater than the amount spent by governments on promoting breastfeeding (Lutter 2013). The published Cochrane Review on support for healthy breastfeeding mothers with healthy term babies found that interventions had more effect on increasing exclusive breastfeeding before four to six weeks and before six months in settings where there were high background rates of breastfeeding initiation compared to areas where there were low or intermediate rates (Renfrew 2012b).

Objectives

1. To identify and describe health promotion activities intended to increase the initiation rate of breastfeeding.

2. To evaluate the effectiveness of different types of breastfeeding promotion activities, in terms of changing the number of women who initiate breastfeeding.

3. To evaluate the effectiveness of different types of breastfeeding promotion activities, in terms of changing the number of women who initiate breastfeeding early (within one hour after birth).

Methods

Criteria for considering studies for this review

Types of studies

We included individual randomised controlled trials (RCTs) or cluster‐RCTs, with or without blinding. There was no limitation of study by country of origin or language. We excluded quasi‐randomised trials and cross‐over trials. We also excluded abstracts for which we could not find the full reports.

Types of participants

Women exposed to interventions intended to promote breastfeeding. This includes pregnant women, mothers of newborn infants, and women who may decide to breastfeed in the future. We also included population subgroups of women, such as women from low‐income or ethnic groups. Women and infants with a specific health problem, e.g. mothers with HIV/AIDS or infants with cleft palate, or premature babies, are excluded from this review.

Types of interventions

Any intervention aiming to promote the initiation of breastfeeding, which takes place before the first breastfeed. Evaluations of interventions taking place after the first breastfeed or whose primary purpose is to affect the duration or exclusivity of breastfeeding are excluded from this review.

Types of outcome measures

This review includes studies that do and do not contribute outcome data.

Primary outcomes

1. Initiation of breastfeeding.

2. Early initiation of breastfeeding (within one hour after birth).

Secondary outcomes

There were no secondary outcomes included in this review.

Search methods for identification of studies

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

Electronic searches

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

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

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

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

2. weekly searches of MEDLINE (Ovid);

3. weekly searches of Embase (Ovid);

4. monthly searches of CINAHL (EBSCO);

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

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

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

See: Dyson 2005 and Fairbank 1999 for details of searching carried out in the previous versions of this review.

Searching other resources

We scanned reference lists of all relevant papers retrieved.

We did not apply any language or date restrictions.

Data collection and analysis

For methods used in the previous versions of this review, see Dyson 2005 and Fairbank 1999.

For this update we used the following methods when assessing the reports identified by the updated search.

Selection of studies

In this update, two review authors (CDG, OOB) independently assessed for inclusion all the potential studies we identified as a result of the search strategy. We resolved any disagreement through discussion or, if required, we consulted a third person (SM).

Data extraction and management

We designed a form to extract data. For eligible studies, four review authors (EJOS, CDG, OOB, EO) extracted the data using the agreed form. For studies published in abstract form only, we attempted to find full reports where available, or contacted authors to provide same. We excluded abstracts for which full reports could not be found. We resolved discrepancies through discussion or, if required, we consulted SM. EJOS entered the data into Review Manager 5 software and checked for accuracy (RevMan 2014).

When information regarding any of the above was unclear, we attempted to contact authors of the original reports to provide further details.

Assessment of risk of bias in included studies

Four review authors independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We resolved any disagreement by discussion.

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

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

We assessed the method as:

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

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

• unclear risk of bias.

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

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

We assessed the methods as:

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

• high risk of bias (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth);

• unclear risk of bias.   

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

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

We assessed the methods as:

• low, high, or unclear risk of bias for participants;

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

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

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

We assessed methods used to blind outcome assessment as:

• low, high, or unclear risk of bias.

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

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

We assessed methods as:

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

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

• unclear risk of bias.

(5) Selective reporting (checking for reporting bias)

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

We assessed the methods as:

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

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

• unclear risk of bias.

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

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

We assessed whether each study was free of other problems that could put it at risk of bias:

• low risk of other bias;

• high risk of other bias;

• unclear whether there is risk of other bias.

(7) Overall risk of bias

We made explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). With reference to (1) to (6) above, we assessed the likely magnitude and direction of the bias and whether we consider it is likely to impact on the findings. We explored the impact of the level of bias through undertaking sensitivity analyses ‐ seeSensitivity analysis. 

Assessment of the quality of the evidence using the GRADE approach

For this update, we assessed the quality of the evidence using the GRADE approach as outlined in the GRADE handbook, in order to assess the quality of the body of evidence relating to the following primary outcomes for the main comparisons: 1. Healthcare professional‐led breastfeeding education and support versus standard care; and 2. Non‐healthcare professional‐led breastfeeding education and support versus standard care.

1. Initiation of breastfeeding.

2. Early initiation of breastfeeding (within one hour after birth).

We used GRADEpro Guideline Development Tool to import data from Review Manager 5 to create 'Summary of findings' tables (RevMan 2014). We produced a summary of the intervention effect and a measure of quality for each of the above outcomes using the GRADE approach. The GRADE approach uses five considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of the body of evidence for each outcome. The evidence can be downgraded from 'high quality' by one level for serious (or by two levels for very serious) limitations, depending on assessments for risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect estimates, or potential publication bias.

Measures of treatment effect

Dichotomous data

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

Continuous data

For continuous data, we used the mean difference if outcomes were measured in the same way between trials. We planned to use the standardised mean difference to combine trials that measured the same outcome but used different methods to measure the outcome.

Unit of analysis issues

Cluster‐randomised trials

We included cluster‐randomised trials in the analyses along with individually‐randomised trials. We used the effect estimates and uncertainty range from the cluster trials to perform the meta‐analysis using the generic inverse variance approach for the meta‐analysis of dichotomous outcomes where trials using cluster‐randomisation techniques were included (Alderson 2004). Further, we conducted a sensitivity analysis to investigate the effects of randomisation unit.

Other unit of analysis issues

We did not include cross‐over trials in this review.

Dealing with missing data

For included studies, we noted levels of attrition. We explored the impact of including studies with high levels of missing data in the overall assessment of treatment effect by using sensitivity analysis.

For all outcomes, we carried out analyses, as far as possible, on an intention‐to‐treat basis, i.e. we attempted to include all participants randomised to each group in the analyses, and all participants were analysed in the group to which they were allocated, regardless of whether or not they received the allocated intervention. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes are known to be missing.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta‐analysis using the Tau², I² and Chi² statistics. We regarded heterogeneity as substantial if I² was greater than 30% and either Tau² was greater than zero, or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. 

Assessment of reporting biases

In future updates, if there are 10 or more studies in a meta‐analysis, we will investigate reporting biases (such as publication bias) using funnel plots. We will assess funnel plot asymmetry visually and if asymmetry is suggested by a visual assessment, we will perform exploratory analyses to investigate it.

Data synthesis

We carried out statistical analysis using the Review Manager 5 software (RevMan 2014). We used fixed‐effect meta‐analysis for combining data where it was reasonable to assume that studies were estimating the same underlying treatment effect, i.e. where trials were examining the same intervention, and the trials’ populations and methods were judged sufficiently similar. If there was clinical heterogeneity sufficient to expect that the underlying treatment effects differed between trials, or if substantial statistical heterogeneity was detected, we used random‐effects meta‐analysis to produce an overall summary if an average treatment effect across trials was considered clinically meaningful. The random‐effects summary was treated as the average range of possible treatment effects and we discuss the clinical implications of treatment effects differing between trials. If the average treatment effect was not clinically meaningful, we did not combine trials.

Where we used random‐effects analyses, the results are presented as the average treatment effect with 95% CIs, and the estimates of T² and I².

Subgroup analysis and investigation of heterogeneity

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

We planned to carry out the following subgroup analyses for primary outcomes.

1. Low‐income (or minority‐ethnic) population versus the general population.

We assessed subgroup differences by interaction tests available within Review Manager 5 (RevMan 2014). We reported the results of subgroup analyses quoting the χ2 statistic and P value, and the interaction test I² value.

Sensitivity analysis

We carried out sensitivity analysis to explore the effects of trial quality and type of randomisation on initiation of breastfeeding. We included only trials with 'adequate' rating on allocation concealment; we considered these trials to be of high quality. We also carried out sensitivity analysis by excluding cluster‐randomised trials and comparing the results of cluster‐randomised trials with the individually‐randomised trials.

Results

Description of studies

This review aimed to evaluate the effectiveness of interventions which aim to encourage women to breastfeed in terms of changes in the number of women who start to breastfeed and in terms of those who initiate breastfeeding within the first hour after birth.

Included studies

Twenty‐eight trials published between 1987 and 2016 involving 107,362 women met the inclusion criteria for this review, exploring the outcome of initiation of breastfeeding and early initiation of breastfeeding (within one hour after birth). See Characteristics of included studies table. Outcome data was contributed by 23 trials involving 104,238 participants. Of these 23 trials, 18 were individually‐randomised studies and five were cluster‐randomised studies. Five trials met the inclusion criteria for this review but did not have usable outcome data and were thus excluded from the analyses (Caulfield 1998; Edwards 2013b; Ickovics 2007; Ickovics 2016; Sandy 2009).

Participants

Twenty of the 23 studies contributing data for the analyses and reporting breastfeeding initiation included a total of 27,865 participants. For one trial (Lindenberg 1990), it was unclear how many participants were randomised to each study arm. Together, the three cluster‐randomised trials reporting early initiation of breastfeeding included 76,373 participants. Of the 20 trials reporting breastfeeding initiation, 14 were purposefully conducted among low‐income or deprived populations (Brent 1995; Chapman 2004; Chapman 2013; Coombs 1998; Edwards 2013a; Efrat 2015; Hill 1987; Kellams 2016; Lindenberg 1990; MacArthur 2009; Reeder 2014; Ryser 2004; Serwint 1996; Srinivas 2015), and six studies did not specifically target low‐income or deprived populations (Forster 2004; Hoddinott 2009; Muirhead 2006; Nolan 2009; ISRCTN47056748; Wambach 2011). Three were conducted among specific ethnic subgroups; two recruited from Latina or Hispanic populations (Chapman 2004; Efrat 2015), and one recruited African‐American women (Edwards 2013a). Although other studies did not report that they specifically recruited ethnic subgroups, two trials conducted in the USA reported that their sample comprised predominately African‐American women (Coombs 1998; Wambach 2011). Other population subgroups targeted by breastfeeding promotion interventions included women undergoing an elective, repeat caesarean section (Nolan 2009), overweight and obese women (Chapman 2013), and adolescents (Wambach 2011). The majority of the 20 trials reporting breastfeeding initiation were conducted among women of mixed feeding intentions antenatally; however, three trials were conducted only among mothers who intended to breastfeed antenatally (Chapman 2004; Chapman 2013; Reeder 2014), and one trial was conducted only among mothers who intended to formula feed or were unsure of how they intended to feed their infant (Ryser 2004).

Interventions

Seven trials evaluated the effect of education and support provided by non‐healthcare professionals (Chapman 2004; Chapman 2013; Edwards 2013a; Efrat 2015; MacArthur 2009; Sandy 2009; Srinivas 2015), compared with standard care on breastfeeding initiation among low‐income or minority‐ethnic populations. Five trials evaluated the effect of breastfeeding education and support compared with standard care (as defined by individual trialists) on breastfeeding initiation (Brent 1995; Hill 1987; Ryser 2004; Serwint 1996; ISRCTN47056748). Four trials evaluated the effect of breastfeeding education using multimedia compared with standard care on breastfeeding initiation (Caulfield 1998; Coombs 1998; Edwards 2013b; Kellams 2016). Three trials evaluated the effect of education and support provided by non‐healthcare professionals compared with standard care on early initiation of breastfeeding (Flax 2014; Kirkwood 2013; Lewycka 2013). Two trials evaluated the effect of education and support provided by non‐healthcare professionals compared with standard care on breastfeeding initiation among the general population (Muirhead 2006; Reeder 2014). Two trials evaluated the effect of breastfeeding education delivered by healthcare professionals combined with peer support, compared with standard care and compared with an attention control intervention (Forster 2004; Wambach 2011). The attention control intervention in Wambach 2011 was similar to the experimental group interventions in the amount of content and timing, but did not focus on breastfeeding. Two trials evaluated the effect of early mother‐infant contact compared with standard care on breastfeeding initiation (Lindenberg 1990; Nolan 2009). Two trials evaluated the effect of group‐based care to individualised care (Ickovics 2007; Ickovics 2016). One trial evaluated the effect of additional community‐based breastfeeding support groups compared with no additional community‐based breastfeeding support groups on the rate of breastfeeding initiation (Hoddinott 2009).

Excluded studies

We excluded 125 reports from this review (see Characteristics of excluded studies). Seventy‐eight of these reports were not concerned with activity intended to increase breastfeeding initiation rates. Thirty reports did not describe a RCT or their was insufficient information about the study design. Eight reports described interventions that took place after birth, eight reports described interventions that did not target the population of interest to this review, and for one trial, breastfeeding promotion was not part of the intervention. We excluded one trial included in the previous version of this review and one trial awaiting classification in the previous version from this current version (Howard 2000; Wolfberg 2004). Howard 2000 did not involve an intervention for promoting breastfeeding initiation, while Wolfberg 2004 was a breastfeeding promotion intervention targeted at fathers.

Risk of bias in included studies

We conducted an assessment of studies for potential sources of selection, performance, attrition and detection bias, and overall risk of bias (as recommended by Higgins 2011) are detailed in Characteristics of included studies.

See Figure 1 and Figure 2 for a summary of 'Risk of bias' assessments.

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

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

Allocation

Sequence generation

In terms of methods used for random sequence generation, we assessed over 65% (n = 19) of the 28 studies as having low risk of bias, while the risk of bias was unclear for the remaining nine studies.

Allocation concealment

We only judged eight of the 28 included studies as adequately concealing allocation to treatment groups and therefore we considered them to be at low risk of bias; we assessed 20 as having unclear allocation concealment.

Blinding

Performance blinding for this type of intervention is problematic as the women receiving the interventions and the staff delivering them are likely to have been aware of group allocation. Consequently we did not assess any studies as being of low risk of performance bias; we deemed six studies to be at unclear risk and 22 studies at high risk.

In the case of detection bias, the objective nature of the outcome being assessed, namely, whether a woman starts to breastfeed or not at a predefined time point, limits the scope for potential influence by the assessor, regardless of their being blind to the participant's group allocation. However, response bias is possible where outcomes are self‐reported. We deemed eight studies to be of low risk of bias, 12 were unclear and eight studies had high risk of detection bias.

Incomplete outcome data

In seven studies there was significant loss to follow‐up of more than 20%, or the groups were not balanced or an 'as‐treated' analysis was done leading to assessments of high risk of attrition bias. We assessed 16 of the studies to be of low risk of attrition bias and five studies to be of unclear risk of attrition bias.

Selective reporting

For most of the studies we did not have access to either trial registration or the study protocol from which we could judge selective reporting. This resulted in an unclear risk of bias for selective reporting in nearly 65% of studies (n = 18). Of the remaining 10 studies for which we had information about a priori outcomes, we assessed six as having low risk of reporting bias and four as having high risk of reporting bias.

Other potential sources of bias

Any other concerns are noted in the Characteristics of included studies tables that include information about the judgements made on the risk of bias. We assessed six studies to be at high risk of bias from other sources, mainly due to differences in baseline characteristics between experimental and control groups. In two studies (Efrat 2015; Ryser 2004), these differences related to infant‐feeding intentions. We judged 11 studies to have low risk of bias from other sources, while 11 had unclear risk of bias from other sources.

Effects of interventions

See: Table 1; Table 2

Summary of findings for the main comparison

Healthcare professional‐led breastfeeding education and support versus standard care

Summary of findings 2

Non‐healthcare professional‐led breastfeeding education and support versus standard care

Statistical analyses for the primary outcomes of initiation of breastfeeding and early initiation of breastfeeding (within one hour after birth) are reported below for 23 trials involving 104,238 women. We analysed studies within seven comparisons, including Analysis 1.1, Analysis 2.1, Analysis 2.2, Analysis 3.1, Analysis 4.1, Analysis 5.1, Analysis 6.1 and Analysis 7.1.

Analysis

Comparison 1 Healthcare professional‐led breastfeeding education and support versus standard care, Outcome 1 Initiation of breastfeeding.

Analysis

Comparison 2 Non‐healthcare professional‐led breastfeeding education and support versus standard care, Outcome 1 Initiation of breastfeeding.

Analysis

Comparison 2 Non‐healthcare professional‐led breastfeeding education and support versus standard care, Outcome 2 Early initiation of breastfeeding.

Analysis

Comparison 3 Healthcare professional‐led breastfeeding education with non‐healthcare professional support versus standard care, Outcome 1 Initiation of breastfeeding.

Analysis

Comparison 4 Healthcare professional‐led breastfeeding education with peer support versus attention control, Outcome 1 Initiation of breastfeeding.

Analysis

Comparison 5 Breastfeeding education using multimedia versus routine care, Outcome 1 Initiation of breastfeeding.

Analysis

Comparison 6 Early mother‐infant contact versus standard care, Outcome 1 Initiation of breastfeeding.

Analysis

Comparison 7 Community‐based breastfeeding groups versus no breastfeeding groups, Outcome 1 Breastfeeding rate at birth.

See Table 1 and Table 2 for each of the main comparisons.

1. Healthcare professional‐led breastfeeding education and support versus standard care

The trials involving breastfeeding education delivered by healthcare professionals included the following interventions: breastfeeding education and support provided during the prenatal and postpartum periods (Brent 1995; ISRCTN47056748); a breastfeeding lecture, including questions and answers (Hill 1987); breastfeeding promotion campaigns (Ryser 2004); and counselling (Serwint 1996). Breastfeeding education was provided in formal settings.

Initiation of breastfeeding: there was evidence for improved breastfeeding initiation among women who received interventions from healthcare professionals (average risk ratio (RR) 1.43, 95% confidence interval (CI) 1.07 to 1.92; 5 trials, 564 women; Tau² = 0.07, I² = 62%; Analysis 1.1; low‐quality evidence). Studies included in this analysis did not report early initiation of breastfeeding.

2. Non‐healthcare professional‐led breastfeeding education and support versus standard care

The trials involving breastfeeding education delivered by non‐healthcare professionals included the following interventions: peer support services provided in addition to routine care (Chapman 2004; MacArthur 2009; Muirhead 2006); peer counselling (Lewycka 2013; Reeder 2014; Srinivas 2015); specialised breastfeeding peer counselling (Chapman 2013); services from paraprofessional doulas (Edwards 2013a); lactation educators (trained research assistants) who implemented phone‐based breastfeeding education and support (Efrat 2015); trained credit officers who led monthly breastfeeding sessions (Flax 2014); and home visits by community‐based surveillance volunteers during pregnancy and in the first week of life (Kirkwood 2013).

Initiation of breastfeeding: There was evidence for improved breastfeeding initiation among women who received interventions delivered by non‐healthcare professional counsellors and in support groups (average RR 1.22, 95% CI 1.06 to 1.40; 8 trials, 5712 women; Tau² = 0.02, I² = 86%; Analysis 2.1; low‐quality evidence). We found considerable heterogeneity in this analysis and conducted a subgroup analysis based on low‐income/minority population and general population. There was no evidence of a differential effect of the interventions based on low‐income/minority population or the general population (test for subgroup differences: Chi² = 0.14, df = 1 (P = 0.71), I² = 0%). We conducted sensitivity analysis by excluding studies with high attrition bias (Chapman 2004; Chapman 2013; Efrat 2015). The overall direction of the effect remained unchanged in favour of non‐healthcare professional‐led breastfeeding education and support. Additionally, statistical heterogeneity was no longer present when we excluded studies with high attrition bias from the analysis (average RR 1.23, 95% CI 1.06 to 1.43; 8 trials, 5712 women; Figure 3)

Sensitivity analysis (excluding high attrition bias studies) of forest plot of comparison: 2 Non‐healthcare professional‐led breastfeeding education and support versus standard care, outcome: 2.1 Initiation of breastfeeding.

Early initiation of breastfeeding: Three studies evaluated the effect of non‐healthcare professional‐led breastfeeding education on early initiation of breastfeeding (Flax 2014; Kirkwood 2013; Lewycka 2013). When all three trials were included in the meta‐analysis, there was a positive but non‐statistically significant increase in the number of women practicing early initiation of breastfeeding (average RR 1.70, 95% CI 0.98 to 2.95; 3 trials, 76,373 women; Tau² = 0.18, I² = 78%; Analysis 2.2; low‐quality evidence). We observed considerable heterogeneity in this analysis.

3. Healthcare professional‐led breastfeeding education with non‐healthcare professional support versus standard care

Two trials involved both breastfeeding education delivered by healthcare professionals and peer support provided to mothers (Forster 2004; Wambach 2011). Wambach 2011 involved a Theory of Planned Behaviour‐based education and counselling intervention delivered by a lactation consultant (registered nurse)‐peer counsellor team. The interventions were compared to standard care or breastfeeding education delivered by healthcare professionals not focused on breastfeeding (attention control) ‐ see below 4. Healthcare professional‐led breastfeeding education with peer support versus attention control).

Initiation of breastfeeding: In both trials randomising 1371 mothers (with data available for 895 women in analysis) (Forster 2004; Wambach 2011), there was no evidence of any effect on the initiation of breastfeeding among mothers for breastfeeding education delivered by healthcare professionals with peer support versus standard care (average RR 1.06, 95% CI 0.88 to 1.27; 2 trials, 895 women; Analysis 3.1). This study did not report early initiation of breastfeeding.

4. Healthcare professional‐led breastfeeding education with peer support versus attention control

In one study involving 390 adolescent mothers (with data available for 237 women) (Wambach 2011), there was no evidence of any effect on the initiation of breastfeeding among adolescent mothers for breastfeeding education delivered by healthcare professionals with peer support versus attention control (RR 1.21, 95% CI 0.97 to 1.51; 1 trial, 237 women; Analysis 4.1). This study did not report early initiation of breastfeeding.

5. Breastfeeding education using multimedia versus routine care

Two trials involving the use of multimedia to provide breastfeeding education included the following interventions: the use of a self‐help manual seven weeks before delivery designed to communicate simple breastfeeding skills to pregnant women compared to usual breastfeeding instructions (Coombs 1998); and a low‐cost breastfeeding education video shown to women prenatally versus control (Kellams 2016).

Initiation of breastfeeding: There was no evidence for improved breastfeeding initiation among women following breastfeeding education interventions using multimedia (average RR 1.16, 95% CI 0.63 to 2.41; 2 trials, 497 women; Tau² = 0.18, I² = 93%; Analysis 5.1). We found considerable heterogeneity between the two studies included in this analysis. Studies included in this analysis did not report early initiation of breastfeeding.

6. Early mother‐infant contact versus standard care

Two trials that promoted mother‐infant contact following either vaginal or caesarean delivery were included in this analysis (Lindenberg 1990; Nolan 2009). In both studies, women who received the intervention were compared with the control group.

Initiation of breastfeeding: There was no evidence for improved breastfeeding initiation among women with increased mother‐infant contact compared to women who received usual care (RR 1.08, 95% CI 0.97 to 1.20; 2 trials, 309 women; Analysis 6.1). Studies included in this analysis did not report early initiation of breastfeeding.

7. Community‐based breastfeeding groups versus no breastfeeding groups

One trial on community‐based breastfeeding groups increased the number of breastfeeding groups available to pregnant and breastfeeding women in intervention localities and compared these to control localities who did not change the number of breastfeeding support groups available to pregnant and breastfeeding women (Hoddinott 2009). They found no difference in rates of any breastfeeding at birth in the intervention clusters compared to the control clusters (mean difference (MD) ‐0.01, 95% CI ‐0.05 to 0.03; 1 trial, 18,603 women; Analysis 7.1). The trialists adjusted the data for pre‐intervention breastfeeding rates and also for clustering. This trial did not report early initiation of breastfeeding.

Discussion

Summary of main results

This updated review considered the evidence of the effect of interventions aimed to promote the initiation of breastfeeding, taking place before the first breastfeed. The review includes 28 studies published from 1987 to 2016. In total, 107,362 women from seven countries participated in the studies included in this review. The majority of studies were conducted in high‐income countries; specifically, Australia (1 study), the USA (19 studies), and the UK (4 studies), although many of these studies did specifically target low‐income populations. Three studies were conducted in lower middle‐income countries (Ghana, Nicaragua, and Nigeria), and one study was conducted in a low‐income country (Malawi). Although the majority of studies were conducted in high‐income populations, only 25% of the 107,362 women included in the review were from high‐income countries as the study from Malawi was very large, with 55,931 participants (Lewycka 2013).

All of the studies conducted in high‐income settings and the study conducted in Nicargua evaluated whether the intervention had an effect on the number of women who ever initiated breastfeeding. Only three of the 28 studies (the studies conducted in the other non‐high income countries) evaluated whether the intervention had any effect on the number of women who initiated breastfeeding early (i.e. within one hour of birth).

Of those studies contributing data, the nature of the intervention varied between studies. Specifically, five studies evaluated the effect of breastfeeding education and support provided by healthcare professionals. Eleven studies evaluated the effect of education and support provided by non‐healthcare professionals (i.e. peer/lay support). Of these, nine were conducted in low‐income or ethnic minority populations, and two were conducted in the general population. Two studies examined combined healthcare professional and non‐healthcare professional support. Two trials examined the effect of multimedia breastfeeding education programmes, and another two trials examined the effect of early mother‐infant contact. Finally, one trial examined the effect of additional community‐based breastfeeding support groups. It should also be noted that even within the same intervention type, the actual components of the intervention also varied. In particular, delivery of the non‐healthcare professional education and support included: education and support provided by peer supporter/counsellors (Chapman 2004; Chapman 2013; Lewycka 2013; MacArthur 2009; Muirhead 2006; Reeder 2014; Srinivas 2015), para‐professional doulas (Edwards 2013a), trained research assistants (Efrat 2015), trained credit officers (Flax 2014), and community‐based surveillance volunteers (Kirkwood 2013).

The pooled data of the five studies (containing 564 women) examining the effect of health education interventions delivered by healthcare professionals indicated that health education interventions delivered by healthcare professionals had a modest effect on increasing the number of women who initiated breastfeeding at any point. However, it should be noted that there was substantial heterogeneity (i.e. differences between the studies in terms of either intervention, population, study design, or outcomes) which may be a result of differences in intervention components or the characteristics of the participants. For instance, four studies evaluated programmes delivered in the USA to low‐income women with a range of feeding intentions and where baseline breastfeeding rates are typically low (Brent 1995; Hill 1987; Ryser 2004; Serwint 1996). Despite variation in programme components, all forms of health education delivered by healthcare professionals appeared to have beneficial effects in terms of breastfeeding initiation.

The eight studies (containing 5712 women) that we combined in a meta‐analysis to evaluate the effect of education and support delivered by non‐healthcare professionals provide evidence for a modest improvement of breastfeeding initiation at any time point. Again, there was a high level of heterogeneity in this analysis. Six of these studies were conducted in low‐income populations, which may call into question the generalisability of the results. However, when we compared studies of general populations with low‐income populations, we did not find any differences.

When we combined the three studies (containing 76,373 women) that evaluated the effect of non‐healthcare professional support on early breastfeeding initiation, we did not identify any evidence of an effect. This analysis also suggested a high level of heterogeneity. When we excluded Flax 2014 from the analysis, a trial with possible selection bias, there was a statistically significant increase in the number of women who practiced early initiation of breastfeeding and no evidence of heterogeneity.

Two studies examined the effect of combined healthcare professional‐led education with telephone peer support (Wambach 2011), or community educator (Forster 2004). The intervention for Wambach 2011 was specifically targeted at adolescent mothers (n = 390) and did not demonstrate any effect on breastfeeding initiation. Similarly, there was no evidence of an intervention effect in the studies which looked at multimedia based interventions. This included one trial of a self‐help manual of 200 women (Coombs 1998), and one trial of a breastfeeding video of 522 women (Kellams 2016).

The two studies that examined the effect of early mother‐infant contact immediately after vaginal birth (Lindenberg 1990), and following caesarean section (Nolan 2009), showed no evidence of effect on breastfeeding initiation specifically. However, the literature on the promotion of the duration of breastfeeding provides clear evidence of the benefits of ongoing mother and infant contact during the hospital stay to support the mother's ability to breastfeed (Moore 2012).

Finally, Hoddinott 2009 was the one study that examined the effect of providing new, additional community‐based breastfeeding support groups in low‐income areas compared to existing breastfeeding groups; it found no effect on breastfeeding initiation.

Overall completeness and applicability of evidence

This updated review now contains 28 studies, out of which 23 studies contribute data to the review. The number of women included in the review has increased considerably from 1553 in the previous version of the review (Dyson 2005), to 107,362 in this update; this in part is driven by a very large study conducted in Malawi, which included 55,931 women (Lewycka 2013). Therefore, whilst the majority of studies in this review were conducted in high‐income countries (Australia, USA, and UK), the majority of participants were from low‐ and middle‐income countries (over 70% of all women). The studies in the USA tended to be small and only involved a total of 5566 women. They also generally targeted specific low‐income or disadvantaged groups. The high preponderance of trials from the USA raises questions about the applicability of the findings to other settings.

The interventions tested across the studies included in this review were very diverse. For example, the educational interventions delivered by healthcare professionals included several distinct approaches: a series of one‐to‐one sessions with a lactation consultation (Brent 1995); a 40‐minute lecture with time for questions (Hill 1987); and one session with a paediatrician that covered a range of topics, of which breastfeeding was just one (Serwint 1996). Standard care was also diverse across the included studies and, in the case of the UK where breastfeeding support is part of standard postnatal care, it is perhaps not surprising that some interventions did not have an effect above and beyond that of standard care. For example, in one trial (ISRCTN47056748), women in both experimental and control groups received care that met UNICEF Baby‐Friendly standards and included a two‐hour antenatal breastfeeding education class. Another trial assessed community‐based support groups in a community where existing breastfeeding support groups were available for control group participants (Hoddinott 2009.

Caution is needed in interpreting the findings of the two trials on early mother‐infant contact (Lindenberg 1990; Nolan 2009). Generalisation of the results is not recommended due to the moderate quality and size of the studies, and to fundamental concerns regarding the practice of routine separation of mother and infant prior to hospital discharge in the case of Lindenberg 1990, and separation following caesarean section in Nolan 2009.

Quality of the evidence

Overall, we judged the methodological quality of the studies included in this review to be mixed. While we assessed over 65% of the studies to have low risk of bias for generating randomisation sequence, we only judged seven studies to have adequately concealed group allocation. This raises concerns regarding the effect of selection bias on study findings.

Given that there are genuine pragmatic considerations when delivering and evaluating breastfeeding promotion interventions, the ability to effectively blind participants and personnel and thereby reduce performance bias is limited. It is therefore unsurprising that we assessed all 28 studies as having high or unclear risk of performance bias. This should be recognised as an inherent weakness of this particular type of evidence base, rather than of the particular studies included in this review. Of more concern is that we assessed 20 studies to have high or unclear risk of detection bias. Even where there was blinding of outcome assessment, there is a risk of response bias in self‐reported outcomes where participants were not blinded.

Incomplete outcome data was also a source of possible bias in this review as we assessed only 16 of the studies as having low risk of attrition bias. The remaining 12 studies either had high rates of loss to follow‐up or failed to report attrition clearly. To minimise the effect of this, we conducted all analyses on the basis of intention‐to‐treat. However, it is possible that this approach may dilute the actual effect of the interventions.

We only assessed six studies as being at low risk of bias for selective outcome reporting; we judged four at high risk and 18 at unclear risk. The high number judged as unclear risk was due to the lack of protocols or trial registration detailing prespecified outcomes.

We assessed six studies as having a high risk of bias from other sources, including differences in baseline characteristics (Brent 1995; Caulfield 1998; Efrat 2015; Ickovics 2007; Ryser 2004; Wambach 2011). Specifically, in the study by Efrat 2015, women in the experimental group had a significantly higher intention to breastfeed than those in the control group. Similary, in the study by Ryser 2004, more participants in the experimental group were undecided about feeding decisions, while more participants in the control group planned to formula feed. Of the remaining studies, we assessed 11 to be of low risk of bias and 11 to be of unclear risk of bias from other sources.

We assessed the quality of the evidence in this review using the GRADE approach (Atkins 2004). See Table 1 and Table 2. For the comparison of healthcare professional‐led breastfeeding education and support versus standard care, we assessed the quality of evidence for the outcome of initiation of breastfeeding as low (Table 1). We downgraded the quality of evidence due to design limitations for most of the studies that contributed data and also high statistical heterogeneity (I2 more than 60%). For the comparison of non‐healthcare professional‐led breastfeeding education and support versus standard care, there was also low‐quality evidence for the outcome of any initiation of breastfeeding due to design limitations in trials (unclear allocation concealment and high risk for attrition bias) and again high heterogeneity (Table 2). We also deemed early initiation of breastfeeding to be of very low‐quality of evidence; downgraded due to lack of blinding, high heterogeneity and imprecision that was demonstrated with a wide 95% CI that crossed the line with no effect (Table 2).

Potential biases in the review process

Bias can potentially be introduced at any stage of the review process. To minimise this, two review authors independently screened studies for inclusion and any disagreements were resolved by a third review author. Data extraction and 'Risk of bias' assessments were performed by one review author and then checked by a second review author. Again, any discrepancies were resolved by a third review author. 'Risk of bias' assessment is subjective in nature and therefore another team of review authors may have graded studies differently. To minimise language bias, we translated any study not reported in English into English, and included it in the review, providing it met the inclusion criteria. Whilst we attempted to identify all the evidence on interventions for the initiation of breastfeeding (including published abstracts from conference proceedings) and followed up ongoing studies, it is feasible that relevant research which is unpublished or not registered in a clinical trials register could have been missed.

Agreements and disagreements with other studies or reviews

Consistent with this review, other reviews have reported that interventions including (Jolly 2012; Rollins 2016; Sinha 2015): health education and counselling provided by healthcare professionals; education provided by non‐healthcare professionals; and peer support, can increase both the number of women who ever initiate breastfeeding and those who initiate breastfeeding within the first hour after birth. Other reviews provide additional evidence regarding the implementation of such interventions. For example, interventions that are delivered in a combination of settings (e.g. home and community, or health systems and community) are more effective than those delivered in one setting only (Sinha 2015). Additionally, Beake 2012 reported that in health system settings where breastfeeding initiation rates are low, structured programmes of interventions may be most effective (Beake 2012). Moreover, Pérez‐Escamilla 2016 found a dose‐response between the number of Baby Friendly Hospital Initiative (BFHI) steps women are exposed to and the likelihood of improved breastfeeding outcomes, including early breastfeeding initiation. The use of new technologies may also be an area for future development, with one study in the review by Rollins 2016 suggesting that mass or social media promotion of breastfeeding potentially has a major effect on early initiation of breastfeeding.

Authors' conclusions

Implications for practice

Health education and counselling provided by healthcare professionals and peer support interventions included in this review are likely to result in some improvements in breastfeeding initiation rates, particularly among low‐income or minority‐ethnic women in the USA, where baseline breastfeeding rates are typically low. Similarly, breastfeeding interventions provided by non‐healthcare professionals could lead to improvements in rates of early initiation of breastfeeding in low‐income countries.

The type of education or support intervention which may be most likely to increase initiation rates appears to be needs‐based, one‐to‐one, informal sessions delivered in the antenatal or perinatal period by a trained breastfeeding professional or peer counsellor. This review update mainly included studies conducted in the USA among low‐income women, thus generalisability may be limited to populations of similar characteristics.

Breastfeeding education using multimedia may not be an effective breastfeeding promotion strategy particularly among low‐income women.

Early mother‐infant contact for women with vaginal or caesarean deliveries was not effective in improving breastfeeding initiation rates. Enabling mothers and infants to remain together for 24 hours a day, 'rooming‐in,' is one of the Ten Steps of the UNICEF/WHO Baby Friendly Hospital Initiative (BFHI) adopted as a global programme to support successful breastfeeding and demonstrated to increase initiation rates for all women in all settings.

Implications for research

The majority of the studies included in this review were conducted in the USA and the effectiveness of interventions reviewed here needs to be assessed widely in diverse countries and settings, in studies that are adequately powered, have adequate methods of randomisation, adequate reporting of losses to follow‐up, and utilise intention‐to‐treat analysis.

Publication of evaluations of effectiveness should detail the content and method of the intervention delivered; the people (e.g. peer or healthcare professional) who delivered it and the training and experience these people had; baseline breastfeeding rates for the study‐site population; and feeding intention for participants within each comparison group.

Future research should aim to evaluate the effectiveness of the intervention to improve both the initiation and duration of any and/or exclusive breastfeeding at least up to six months to enable appropriate planning and implementation of interventions during pregnancy and the postnatal period. In addition, studies need to provide clear descriptions of both the intervention and study outcomes.

Further research to evaluate interventions that combine health education or support before the birth with support during the days immediately after the birth should be evaluated and compared with those that offer education alone.

Further research into early mother‐infant contact regardless of mode of delivery, followed by rooming‐in until hospital discharge is needed to evaluate the effect of early mother‐infant contact on increasing breastfeeding initiation rates among various population groups.

Studies are needed to help women to find ways to overcome societal barriers to breastfeeding, including policy‐level interventions.

Good‐quality research to evaluate the effectiveness of breastfeeding promotion and support on breastfeeding rates among maternity and community services who achieve fully accredited BFI/BFHI status would further inform policy and practice.

What's new

History

Protocol first published: Issue 3, 1999
Review first published: Issue 2, 2005

Acknowledgements

Developmental work for the original review (development of the conceptual framework for identification and classification of health promotion interventions and the search strategy) was conducted for the purposes of 'A systematic review to evaluate the effectiveness of interventions to promote the initiation of breastfeeding', funded by and produced for the National Health Service (NHS) Research and Development Health Technology Assessment Programme, UK (Fairbank 2000). Co‐authors of that review, not involved in the adaptation and update of this Cochrane Review were: S O'Meara, Dr AJ Sowden, D Lister‐Sharp (NHS Centre for Reviews and Dissemination, University of York, UK), and Dr M Woolridge (Mother and Infant Research Unit, Faculty of Medicine, University of Leeds, UK). An international Advisory Panel of breastfeeding and health promotion experts also provided guidance on the classification of studies and interpretation of findings for the Health Technology Assessment (HTA) 2000 review. Members of the Advisory Panel were: Rosamund Bryar, Petra Clarke, Leslie Davidson, Elisabeth Helsing, Stuart Logan, Miranda Mugford, Patricia Muirhead, Felicity Savage, Jim Sikorski, and Mary Smale.

Searches for studies relevant to this substantive update of this Cochrane Review were conducted by Lynn Hampson (Information Specialist, Cochrane Pregnancy and Childbirth, Liverpool Women's Hospital Foundation Trust).

Thanks to Hannah Soley for translating Lucchini 2013.

Professor Martin Bland, University of York, provided statistical advice for a previous update.

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

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

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

Appendices

Appendix 1. Note 1

Unless otherwise stated, the sources of international breastfeeding data are the WHO Global Strategy for Infant and Young Child Feeding (WHO 2003), or the WHO Global Databank on Breast‐Feeding (WHO Data Bank 1996). The Databank is not comprehensive at this time and is dependent on data collected by individual countries using a variety of methods or indicators, or both.

Appendix 2. Note 2

Figures presented are not standardised for mother's age and age at which she completed full‐time education, factors strongly associated with the incidence of breastfeeding. Standardised figures were not available for individual countries. Available data for changes in breastfeeding rates for England and Wales between 2000 and 2005, when standardised for mother's age and education, report a real increase in breastfeeding rates which was not simply due to changes in the sample composition (Bolling 2007).

Notes

Edited (no change to conclusions)

Data and analyses

Comparison 1

Healthcare professional‐led breastfeeding education and support versus standard care

Comparison 2

Non‐healthcare professional‐led breastfeeding education and support versus standard care

Comparison 3

Healthcare professional‐led breastfeeding education with non‐healthcare professional support versus standard care

Comparison 4

Healthcare professional‐led breastfeeding education with peer support versus attention control

Comparison 5

Breastfeeding education using multimedia versus routine care

Comparison 6

Early mother‐infant contact versus standard care

Comparison 7

Community‐based breastfeeding groups versus no breastfeeding groups

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of studies awaiting assessment [ordered by study ID]

Characteristics of ongoing studies [ordered by study ID]

Differences between protocol and review

Methods updated to current standard text of Cochrane Pregnancy and Childbirth.

We have edited the main outcomes from 'Initiation and duration of any and exclusive breastfeeding' to:

1. initiation of breastfeeding;

2. early initiation of breastfeeding (within one hour after birth).

We have assessed the quality of the body of evidence using the GRADE approach.

We have redefined our planned subgroup analysis to be based on low‐income (or minority‐ethnic) population versus the general population.

In protocol but not review ‐ Types of participants: In order to examine intermediate/process outcomes, other participants exposed to such interventions, for example partners, health professionals and employers will be considered.

In protocol but not review ‐ Types of outcomes: Process outcomes (health literacy, public policy, social influence).

Contributions of authors

The 2016 update (which involves new authors):

• Olukunmi Balogun: independent screening, data extraction, quality appraisal, analysis and synthesis of findings, edited and updated results, and revised the manuscript.

• Elizabeth J O'Sullivan: data extraction, quality appraisal, analysis and synthesis of findings, updated results, and revised the manuscript.

• Alison McFadden: edited results and discussion, and revised the manuscript.

• Erika Ota: data extraction, quality appraisal, analysis and synthesis of findings, and 'Summary of findings' tables.

• Anna Gavine: edited results and discussion, and revised the manuscript.

• Christine Dieterich Garner: independent prescreening, data extraction, and quality appraisal.

• Mary Renfrew (contact author): revised the manuscript.

• Steve MacGillivray: applied the study selection criteria, edited results and discussion, and revised the manuscript.

All the authors read and approved the final version to be published.

Sources of support

Internal sources

• Mother and Infant Research Unit, University of Leeds, UK.

External sources

• Canadian Cochrane Child Health Field Bursary Award, Canada.

• York Centre for Reviews and Dissemination, UK.

• Evidence and Programme Guidance Unit, Department of Nutrition for Health and Development, World Health Organization, Switzerland.

Declarations of interest

Olukunmi O Balogun: none known.

Elizabeth J O'Sullivan: none known.

Alison McFadden: none known.

Erika Ota: none known.

Anna Gavine: none known.

Christine D Garner: none known.

Mary J Renfrew: none known.

Stephen MacGillivray: none known.

References

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