Azad 2010.

Methods	Parallel arm cluster‐RCT conducted at 18 sites in Bangladesh between Feb 2005 and Dec 2008.
Participants	Sample size: 18 clusters (6389 women). Clusters: purposive sampling was performed in 3 different divisions in Bangladesh on the basis of the districts having active Diabetic Association of Bangladesh (BADAS) offices. Within these districts, sub districts (upazilas) and unions (the lowest level administrative units in rural Bangladesh) were also purposefully sampled by use of recommendations from BADAS representatives, the main criteria being perceived limited access to perinatal health care in those unions, and a feasible travelling distance from BADAS district headquarters. Individuals: women were eligible to participate in the study if they were aged 15–49 years, residing in the project area, and had given birth during the study period.
Interventions	Target: health system (re‐organisation of health services intervention) and community (education or IEC intervention). Arm 1 (9 clusters, 17,514 births ITT): in intervention clusters, a facilitator convened 18 groups every month to support participatory action and learning for women, and to develop and implement strategies to address maternal and neonatal health problems. 5 of the 9 clusters became TBA intervention clusters and 4 became controls. 482 TBAs were given basic training in undertaking clean and safe deliveries, providing safe delivery kits, recognising danger signs in mothers and infants, making emergency preparedness plans, accompanying women to facilities, and undertaking mouth‐to‐mouth resuscitation. They also received additional training in neonatal resuscitation with bag valve‐mask. Arm 2 (9 clusters, 18,599 births ITT): health services strengthening intervention and basic training of TBAs.
Outcomes	Trial primary outcome: neonatal mortality rate. Review outcomes reported: Primary: ANC coverage (at least 4 visits), maternal mortality. Secondary: health facility deliveries, tetanus protection, perinatal mortality, neonatal mortality. Follow‐up: outcomes measured at 1, 2, and 3 years. We have used mortality data from Table 2 (Azad 2010 p. 1197). We used Years 1‐3 combined, excluding the "temporary and tea garden residents" who may not have received the full intervention. We calculated our own cluster adjusted ORs for antenatal care outcomes using the percentages from Table 4, p. 1200 and the denominators from years 1‐3 in Table 2, p. 1197 (all births: intervention n = 15,696 and control n = 15,257).
Notes	Funders: Women and Children First, the UK Big Lottery Fund, Saving Newborn Lives, and the UK Department for International Development.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The allocation sequence was decided upon by the project team before drawing" pg 1194 "and was based on clusters rather than individuals."
Allocation concealment (selection bias)	Unclear risk	Not clear how allocation was concealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Recruitment bias (for cluster RCTs)	Unclear risk	"Additionally, about 10% of mothers in our study area were temporary residents and mainly came into the cluster areas to give birth, since the tradition is for women to go to their mothers’ home just before delivery. These temporary residents were not exposed to the women’s group intervention, and often had returned to their marital homes outside the study area before the postnatal interview." Presumably this would have affected all clusters.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Not reported.
Selective reporting (reporting bias)	Low risk	Most relevant outcomes reported.
Analysis bias	Low risk	Analysis appropriate for clusters; ICC reported; ITT analysis performed.
Other bias	Unclear risk	Baseline imbalances not reported.
Overall risk assessment	Low risk	No serious risk of bias concerns.