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Journal Trials
Year 2008
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Background: The United Nations Millennium Development Goals look to substantial improvements in child and maternal survival. Morbidity and mortality during pregnancy, delivery and the postnatal period are prime obstacles to achieving these goals. Given the increasing importance of urban health to global prospects, Mumbai's City Initiative for Newborn Health aims to improve maternal and neonatal health in vulnerable urban slum communities, through a combination of health service quality improvement and community participation. The protocol describes a trial of community intervention aimed at improving prevention, care seeking and outcomes. Objective: To test an intervention that supports local women as facilitators in mobilising communities for better health care. Community women's groups will build an understanding of their potential to improve maternal and infant health, and develop and implement strategies to do so. Design: Cluster-randomized controlled trial. Methods: The intervention will employ local community-based female facilitators to convene groups and help them to explore maternal and neonatal health issues. Groups will meet fortnightly through a seven-phase process of sharing experiences, discussion of the issues raised, discovery of potential community strengths, building of a vision for action, design and implementation of community strategies, and evaluation. The unit of allocation will be an urban slum cluster of 1000-1500 households. 48 clusters have been randomly selected after stratification by ward. 24 clusters have been randomly allocated to receive the community intervention. 24 clusters will act as control groups, but will benefit from health service quality improvement. Indicators of effect will be measured through a surveillance system implemented by the project. Key distal outcome indicators will be neonatal mortality and maternal and neonatal morbidity. Key proximate outcome indicators will be home care practices, uptake of antenatal, delivery and postnatal care, and care for maternal and neonatal illness. Data will be collected through a vital registration system for births and deaths in the 48 study clusters. Structured interviews with families will be conducted at about 6 weeks after index deliveries. We will also collect both quantitative and qualitative data to support a process evaluation. © 2008 More et al; licensee BioMed Central Ltd.

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Journal PLoS medicine
Year 2012
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INTRODUCTION: Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health. METHODS AND FINDINGS: A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60-1.22), and the neonatal mortality rate higher (1.48, 1.06-2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90-1.57). We have no evidence that these differences could be explained by the intervention. CONCLUSIONS: Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors. TRIAL REGISTRATION: Current Controlled Trials ISRCTN96256793