Elsevier

The Lancet

Volume 364, Issue 9438, 11–17 September 2004, Pages 970-979
The Lancet

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Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial

https://doi.org/10.1016/S0140-6736(04)17021-9Get rights and content

Summary

Background

Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years. 90% of deliveries in the poorest quintile of households happen at home. We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates.

Methods

We pair-matched 42 geopolitical clusters in Makwanpur district, Nepal, selected 12 pairs randomly, and randomly assigned one of each pair to intervention or control. In each intervention cluster (average population 7000), a female facilitator convened nine women's group meetings every month. The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them. We monitored birth outcomes in a cohort of 28931 women, of whom 8% joined the groups. The primary outcome was neonatal mortality rate. Other outcomes included stillbirths and maternal deaths, uptake of antenatal and delivery services, home care practices, infant morbidity, and health-care seeking. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN31137309.

Findings

From 2001 to 2003, the neonatal mortality rate was 26·2 per 1000 (76 deaths per 2899 livebirths) in intervention clusters compared with 36·9 per 1000 (119 deaths per 3226 livebirths) in controls (adjusted odds ratio 0·70 [95% CI 0·53–0·94]). Stillbirth rates were similar in both groups. The maternal mortality ratio was 69 per 100000 (two deaths per 2899 livebirths) in intervention clusters compared with 341 per 100000 (11 deaths per 3226 livebirths) in control clusters (0·22 [0·05–0·90]). Women in intervention clusters were more likely to have antenatal care, institutional delivery, trained birth attendance, and hygienic care than were controls.

Interpretation

Birth outcomes in a poor rural population improved greatly through a low cost, potentially sustainable and scalable, participatory intervention with women's groups.

Introduction

Of the world's 4 million annual neonatal deaths, 98% occur in developing countries.1 Infant and child mortality rates have declined, notably through better control of diarrhoea, pneumonia, and vaccine-preventable disease, and the importance of the newborn period has increased. In India, neonatal mortality now accounts for up to 70% of infant mortality.2 Most perinatal and neonatal deaths happen at home, and many could be avoided with changes in antenatal, delivery, and newborn care practices.3 However, primary and secondary health-care systems have difficulties in reaching poor rural residents, and a potentially effective perinatal health strategy must recognise this reality. In Makwanpur district, Nepal, for example, 90% of women give birth at home, and trained attendance at delivery is uncommon.4

We are unaware of any randomised controlled trial of community-based strategies to reduce neonatal mortality, a shortfall that indicates the absence of information on demand-side interventions.5 Two studies have made important contributions in this area. Bolivia's Warmi project—an uncontrolled before-and-after study—was implemented in a poor rural population of 15000 people with little health-system infrastructure. The project worked with women's groups to encourage participatory planning for mother and infant care,6, 7, 8 and showed a fall in perinatal mortality rate from 117 to 44 per 1000 births over 3 years. In India, the SEARCH group reported a non-randomised controlled study from a rural population of 80000 in Gadchiroli, Maharashtra.9 The intervention entailed training of traditional birth attendants, health education, and a new cadre of supervised village health workers who visited newborn infants at home, identified warning signs, and managed sepsis with antibiotics. After 3 years the neonatal mortality rate had fallen by 62%. Replication and scaling up of this exciting community-based model presents policy makers with some challenges, particularly because of the need for a new cadre of community health worker to deliver injectable antibiotics at home.

Community participation has long been advocated to build links between primary services and their users,10, 11, 12 and to improve service quality.13, 14, 15 However, the evidence base for the effectiveness of participatory models is scarce.5, 16 Previously, we showed no effect of direct education by health workers on infant care practices and care-seeking behaviour after delivery.17 In view of the Bolivian model, we thought that a participatory approach might have more effect on perinatal care practices and might increase consultation for difficulties in pregnancy and the newborn period. Although external facilitators of user groups have proven valuable in agriculture and forestry,18, 19 to our knowledge no study has rigorously assessed such a potentially scalable approach to improving reproductive health outcomes.

We postulated that a community-based participatory intervention could reduce the neonatal mortality rate from 60 to 40 per 1000 livebirths. The MIRA Makwanpur trial was a cluster-randomised controlled trial of such an intervention in a rural mountainous area of Nepal. The trial tested a large-scale intervention, using facilitators to work with women's groups in a population of 170000 covering 1600 km2. A cluster design was chosen because the intervention was structured around communities rather than individuals.

Section snippets

Study location and population

With a population of more than 23 million and a gross national income of US$240 per person,20 Nepal is a poor country whose development challenges are exacerbated by its geography and unstable political situation. Life expectancy is 61 years. The total fertility rate is 4·4 children per woman in rural areas,21 and the estimated maternal mortality ratio is 539 per 100000 livebirths.22 57% of women cannot read.23 The estimated infant mortality rate is 64 per 1000 livebirths, the neonatal

Results

Figure 3 shows the trial profile. All 24 clusters selected for inclusion received their allocated intervention. Between Nov 1, 2001, and Oct 31, 2003, 3190 pregnancies happened in intervention clusters and 3524 in controls. Presumptive miscarriage rates were 2·3% (73/3190) in intervention clusters and 2·2% (77/3524) in control clusters. Loss to pregnancy follow-up as a result of migration, withdrawal of consent, or incompleteness of surveillance data was 5·4% (172/3190) in intervention clusters

Discussion

We have shown that an intervention in rural Nepal, entailing women's groups convened by a local woman facilitator, reduced neonatal mortality by 30%. Maternal mortality, although not a primary outcome of the trial, was also significantly lower in intervention areas. The intervention seemed to bring about changes in home-care practices and health-care seeking for both neonatal and maternal morbidity. The activities of one facilitator in a population of 7000 rapidly reached a high proportion of

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