Fottrell 2013.

Methods	Parallel‐arm cluster‐RCT conducted at 18 sites/unions in Bangladesh between Jan 2009 and June 2011.
Participants	Sample size: 18 clusters (532,996 population). Clusters: purposeful selection of the 3 districts on the basis of having active Diabetic Association of Bangladesh offices and somewhat representing the social and geographical diversity of Bangladesh..basis of perceived limited access to perinatal health care and feasible accessibility from Diabetic Association of Bangladesh district headquarters. Individuals: women whose childbirths or deaths were recorded in the study areas.
Interventions	Target: community (IEC intervention). Arm 1 (9 clusters, 12,135 women/births): women's participation groups; effect of monthly participatory learning and action cycle focus on maternal and newborn health. Arm 2 (9 clusters, 13,459 women/births): control not described (presumably no women's participation groups).
Outcomes	Trial primary outcome: neonatal mortality rate. Review outcomes reported: Primary: ANC coverage (at least 4 visits). Secondary: health facility deliveries, perinatal and neonatal mortality. Follow‐up: data collected monthly for 24 months. 1 of the control areas (with 3 clusters) included "tea‐garden estates". Residents on these estates were described as having more social and economic disadvantage, and separate analyses were carried out including and excluding these areas. For the analyses in this review, we have used the outcome data that excludes these tea garden residents.
Notes	Funders: Big Lottery Fund International Strategic Grant, Wellcome Trust Strategic Award. For the outcome of perinatal mortality we have used stillbirths plus early neonatal deaths. We calculated our own OR using an ICC because the adjusted perinatal deaths OR (without Tea Garden residents) is asymmetrical and would not go into RevMan. See Fottrell 2013 (Table 3, p. 823).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Paper stated that the sequence "had been decided before drawing the papers" (containing the allocation).
Allocation concealment (selection bias)	Low risk	Allocated "by blindly pulling pieces of paper, each representing 1 union from a bottle".
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	The intervention was not masked, it is not clear how lack of blinding might affect outcomes reported.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The implementation and in‐country monitoring and evaluation teams were blind to the allocation arms" during interim analysis (June 2011).
Recruitment bias (for cluster RCTs)	Low risk	None noted.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Study flow chart included displaying reasons for exclusions. Missing data described as 13% on home delivery practice and 0.8% on other secondary outcomes.
Selective reporting (reporting bias)	Unclear risk	Relevant outcomes reported although separate analyses for some control group births meant that results were more difficult to interpret.
Analysis bias	Unclear risk	Analysis appropriate for clusters but ICC not reported and ITT analysis only performed for primary outcomes.
Other bias	Unclear risk	1 of the control areas (with 3 clusters) included "tea‐garden estates"; residents on these estates were described as having more social and economic disadvantage and separate analyses were carried out including and excluding these areas. For the analyses in this review, we have used the outcome data that excludes these tea garden residents.
Overall risk assessment	Unclear risk	We were uncertain whether some of the above might have significantly biased the results.