More 2012.

Methods	A parallel arm cluster‐RCT conducted in India between Oct 2006 and Sept 2009.
Participants	Sample size: 48 clusters (18,197 individuals). Clusters: eligible clusters were communities in urban slums in Mumbai for which a perinatal vital registration was set up as part of the City Initiative for Newborn Health in 2005. The wards were selected purposively for the 2005 Initiative based on accessibility and relative infant mortality rates. Communities with transient populations and areas where resettlement was being negotiated were both excluded. Individuals: women of all ages residing in intervention clusters, whether pregnant or not pregnant, were invited to attend women's groups.
Interventions	Target: community (IEC intervention). Arm 1: women were invited to weekly meetings that emphasized knowledge of local health services, perinatal health care, and negotiating optimal care with family and health providers. Arm 2: no weekly meetings. Surveillance data were collected in both intervention and control areas. 12 interviewers collected these data at 6 weeks postpartum. Unwell mothers or infants in either arm were referred and treatment expedited.
Outcomes	Trial primary outcome: perinatal care, maternal morbidity, and extended perinatal mortality. Review outcomes reported: Primary: maternal mortality. Secondary: professional ANC, health facility delivery, perinatal mortality, neonatal mortality. Follow‐up: weekly women's group meetings and attendance records. Interviews took place 6 weeks postpartum. Retrospective census at end of trial to pick up any missed births in all 48 clusters.
Notes	Funders: ICICI Foundation for Inclusive Growth – Centre for Child Health and Nutrition, and the Wellcome Trust. DO was funded by a Wellcome Trust Fellowship (081052/Z/06/Z).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation by "drawing of lots".
Allocation concealment (selection bias)	Unclear risk	Allocation not concealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Interviewers may have been aware of the assignment of their particular area, but the authors argue that they "were focused on their task (surveillance) and did not dwell on the comparative nature of the trial." Data analysts were blinded.
Recruitment bias (for cluster RCTs)	Unclear risk	9 clusters were expanded for insufficient births, and 2 clusters reduced for excess births.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition was less than 20% in each arm, and authors have provided a study flow diagram with documented reasons for loss to follow‐up.
Selective reporting (reporting bias)	Low risk	Relevant outcomes were reported.
Analysis bias	Low risk	Analysis appropriate for clusters; ITT analysis performed; ICC not reported.
Other bias	Unclear risk	Other initiatives during the trial period include outreach services by health volunteers, birth registration and pulse polio campaigns and infectious disease surveillance. Conditions in slums improved over the trial period.
Overall risk assessment	Unclear risk	We were uncertain whether the risk of bias concerns above might have impacted the results.