Background

A quarter of the world's neonatal deaths and 15% of maternal deaths happen in India. Few community-based strategies to improve maternal and newborn health have been tested through the country's government-approved Accredited Social Health Activists (ASHAs). We aimed to test the effect of participatory women's groups facilitated by ASHAs on birth outcomes, including neonatal mortality.

Methods

In this cluster-randomised controlled trial of a community intervention to improve maternal and newborn health, we randomly assigned (1:1) geographical clusters in rural Jharkhand and Odisha, eastern India to intervention (participatory women's groups) or control (no women's groups). Study participants were women of reproductive age (15–49 years) who gave birth between Sept 1, 2009, and Dec 31, 2012. In the intervention group, ASHAs supported women's groups through a participatory learning and action meeting cycle. Groups discussed and prioritised maternal and newborn health problems, identified strategies to address them, implemented the strategies, and assessed their progress. We identified births, stillbirths, and neonatal deaths, and interviewed mothers 6 weeks after delivery. The primary outcome was neonatal mortality over a 2 year follow up. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN31567106.

Findings

Between September, 2009, and December, 2012, we randomly assigned 30 clusters (estimated population 156 519) to intervention (15 clusters, estimated population n=82 702) or control (15 clusters, n=73 817). During the follow-up period (Jan 1, 2011, to Dec 31, 2012), we identified 3700 births in the intervention group and 3519 in the control group. One intervention cluster was lost to follow up. The neonatal mortality rate during this period was 30 per 1000 livebirths in the intervention group and 44 per 1000 livebirths in the control group (odds ratio [OR] 0.69, 95% CI 0·53–0·89).

Interpretation

ASHAs can successfully reduce neonatal mortality through participatory meetings with women's groups. This is a scalable community-based approach to improving neonatal survival in rural, underserved areas of India.

Funding

Big Lottery Fund (UK).

Every year 2·7 million infants die in the first month of life, 2·6 million are stillborn, and 303 000 women die of consequences of pregnancy and childbirth. ^{1 and 2} Most of these deaths can be prevented by increased access to known interventions before conception and during the perinatal period. ² A recent analysis estimated that community and primary care strategies to increase the coverage of such interventions could prevent a third of neonatal deaths worldwide in the next 5 years. ^{3 and 4} WHO and UNICEF's Every Newborn Action Plan ⁵ recommends two main community-based strategies to improve survival: postnatal home visits for mothers and newborn infants and participatory women's groups. During postnatal home visits, health workers counsel families on essential newborn care, and examine, treat, or refer infants with health problems. ⁶ Visits have led to 30–60% reductions in neonatal mortality in proof-of-principle trials, and smaller effects in larger studies embedded within government programmes. ⁷ In the women's group approach, a female facilitator supports a group through a four-phase participatory learning and action cycle. Groups identify and prioritise problems in pregnancy, delivery, and the postnatal period, decide on strategies to address these problems, implement the strategies, and assess their progress. ⁸ A meta-analysis ⁹ of seven trials noted that women's groups led to an overall 20% reduction in neonatal mortality, rising to 33% when more than a third of pregnant women participated in groups. Effective strategies such as postnatal home visits and participatory women's groups need to be scaled up through government systems, with a focus on high mortality areas. ⁴