Lewycka 2013a.

Methods	2 by 2 factorial cluster‐RCT conducted in Malawi between 2005 and 2009.
Participants	Sample size: 42 clusters (18960 pregnancies, 18,744 livebirths analysed). Clusters: the unit of randomisation was a cluster of villages and not an individual village. Cluster design was based on census enumeration areas with population of approximately 3000, surrounded by a buffer zone to reduce contamination. The target population was rural communities; the urban administrative centre of the district was excluded. Individuals: all women aged 10‐49 who were willing to participate were enrolled. Women who had a terminal family planning procedure were excluded from the final sample, but not from participating in the intervention.
Interventions	Target: community (IEC). Arm 1 (12 clusters, 4557 pregnancies): facilitator initiated women's groups to discuss issues of pregnancy, childbirth and newborn and infant health, as well as peer counselling (infant feeding and care counselling via 5 home visits during and after pregnancy (3rd trimester, week after birth, at 1, 3 and 5 months). Arm 2 (12 clusters, 4722 pregnancies): facilitated women's groups. Arm 3 (12 clusters, 4660 pregnancies): peer counselling via home visits. Arm 4 (12 clusters, 5021 pregnancies): no intervention. All clusters benefited from training of staff in health facilities in essential newborn care.
Outcomes	Trial primary outcomes: maternal, perinatal, neonatal and infant mortality rates, and exclusive breastfeeding. Review outcomes reported: Primary: ANC coverage (at least 4 visits), maternal mortality. Secondary: ANC coverage (at least 1 visit), health facility deliveries, IPT for malaria, tetanus protection, HIV screening, perinatal mortality, neonatal mortality. Follow‐up: data were gathered monthly between December 2004 and December 2010. All pregnancies, births and deaths were identified, and surviving mothers and infants were followed for up to 1 year.
Notes	Funders: Saving Newborn Lives, UK Department for International Development, Wellcome Trust, Institute of Child Health, and UNICEF Malawi. The primary trial report presents several different analyses, including 1 where Interventions were combined, in order to evaluate the effect of women's groups (arm 1 + 2 combined versus arm 3 + 4 combined) and the effect of peer counselling (arm 1 + 3 combined versus arm 2 + 4 combined) separately. For the analysis in our review's Comparison 1: Lewycka 2013a refers to the women's group intervention only. Lewycka 2013b refers to the peer counselling intervention only. These 2 single‐intervention arms are compared to the arm with no intervention. For the analysis in our review's Comparison 2: Lewycka 2013a refers to the trial arm that received both women's groups and peer counselling. This arm is compared to the arm with no intervention.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation done with computer program Stata.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Group assignment was masked for data analysis. Data collection was conducted independently of program implementation and was not fed back to inform the intervention.
Recruitment bias (for cluster RCTs)	Low risk	None noted.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Women with miscarriages were excluded from analysis. Loss to follow‐up about 20%. Miscarriage rates varied across study arms and were more frequent in the combined intervention cluster.
Selective reporting (reporting bias)	Low risk	Relevant outcomes reported.
Analysis bias	Low risk	Analysis appropriate for clusters; no ICC reported; ITT analysis performed.
Other bias	Unclear risk	The authors discuss an interaction between the 2 interventions and baseline imbalances after randomisation across several outcomes.
Overall risk assessment	Unclear risk	We were concerned that the exclusion of women with miscarriages might bias maternal death rates.