Background: Community mobilisation through participatory women's groups might improve birth outcomes in poor rural communities. We therefore assessed this approach in a largely tribal and rural population in three districts in eastern India. Methods: From 36 clusters in Jharkhand and Orissa, with an estimated population of 228 186, we assigned 18 clusters to intervention or control using stratified randomisation. Women were eligible to participate if they were aged 15-49 years, residing in the project area, and had given birth during the study. In intervention clusters, a facilitator convened 13 groups every month to support participatory action and learning for women, and facilitated the development and implementation of strategies to address maternal and newborn health problems. The primary outcomes were reductions in neonatal mortality rate (NMR) and maternal depression scores. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21817853. Findings: After baseline surveillance of 4692 births, we monitored outcomes for 19 030 births during 3 years (2005-08). NMRs per 1000 were 55·6, 37·1, and 36·3 during the first, second, and third years, respectively, in intervention clusters, and 53·4, 59·6, and 64·3, respectively, in control clusters. NMR was 32% lower in intervention clusters adjusted for clustering, stratification, and baseline differences (odds ratio 0·68, 95% CI 0·59-0·78) during the 3 years, and 45% lower in years 2 and 3 (0·55, 0·46-0·66). Although we did not note a significant effect on maternal depression overall, reduction in moderate depression was 57% in year 3 (0·43, 0·23-0·80). Interpretation: This intervention could be used with or as a potential alternative to health-worker-led interventions, and presents new opportunities for policy makers to improve maternal and newborn health outcomes in poor populations. Funding: Health Foundation, UK Department for International Development, Wellcome Trust, and the Big Lottery Fund (UK). © 2010 Elsevier Ltd. All rights reserved.
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