More 2012.
| Methods | Cluster‐randomised controlled trial in 24 intervention and 24 control settlements covering a population of 283,000 in India | |
| Participants | Key participants were women who joined groups in 24 intervention clusters to be compared with 24 control clusters (n = 15,192 births) | |
| Interventions | Intervention (n = 7656 births): study recruited 1 full‐time facilitator in each intervention cluster of about 1000 households. This sakhi (friend) was a local woman with secondary education and leadership skills, preferably married with children. Her role was to conduct meetings with women, attend planning and supervision of meetings, and support group action. After training, she began by profiling her settlement and building rapport with local stakeholders. She also attended regular training on a range of healthcare topics. Over about 6 months, she set up 10 women's groups, formative work having shown that women's mobility tended to be confined to their own alley. The groups met fortnightly, and she met weekly with other sakhis and her supervisor. The intervention followed a 36‐meeting cycle that was pre‐determined in general but developed iteratively in detail. There was no set point at which women had to join a group, and women of all ages, pregnant and non‐pregnant, were welcome to participate. Study took a participatory approach with emphasis on sharing and peer learning, rather than on the sakhi as an expert resource, and used the change method of appreciative inquiry to focus on the positive and to build energy for action through identification of the strengths of participants and their families and neighbourhoods Control (n = 7536): standard care |
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| Outcomes | Perinatal care, maternal morbidity, extended perinatal mortality | |
| Notes | Funding: interventions involved in the City Initiative for Newborn Health were funded by the ICICI Foundation for Inclusive Growth – Centre for Child Health and Nutrition. Evaluative aspects of the trial were funded from 2007 by The Wellcome Trust. DO was funded by a Wellcome Trust Fellowship (081052/Z/06/Z). The funding agency had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "in a transparent process, social workers external to the trial drew lots to select 48 in blocks of eight per ward, and then to allocate four clusters per block to the intervention" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "the nature of the intervention precluded allocation concealment" Comment: since it was a cluster randomised trial, allocation concealment should not be an issue, as in this design, all clusters are randomised at once |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "emphasis on participation and demystification of research" Comment: probably not done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up was around 18% in both intervention and control arms, and reasons for loss to follow‐up were similar across both arms |
| Selective reporting (reporting bias) | Low risk | Comment: this is a registered trial, and this study has reported all outcomes mentioned in the protocol |
| Other bias | Low risk | Comment: study seems to be free from other biases |