Abstract
BackgroundProgress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups.MethodsA cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home care practices and health care use are collected through interviews.Trial registrationISRCTN: ISRCTN01805825
Highlights
Progress on neonatal survival has been slow in most countries
Community interventions and the need for further research Substantial reductions in neonatal mortality can be achieved, even in contexts where health care systems are very weak, as has been shown in cluster randomized trials of community mobilisation with women’s groups in rural Nepal and rural tribal areas in India [20,21]. These interventions were modelled on a before-andafter study in remote rural Bolivia, which used a participatory learning and action cycle with women’s groups to improve home care practices and health care use [22]
We have set up a prospective surveillance system in which all live births, stillbirths, neonatal deaths and deaths to women of reproductive age in the study population are recorded and combined with data on home care practices and health care use collected through an interview 6 weeks post-partum [27]
Summary
A cluster randomised trial of a participatory women’s group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women’s group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death.
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