UCL Centre for International Health and Development, Institute of Child Health, 30 Guildford Street, London WC1N 1EH, UK.
Trials. 2011 Sep 26;12:208. doi: 10.1186/1745-6215-12-208.
Progress 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.
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. 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.
ISRCTN: ISRCTN01805825.
在大多数国家，新生儿存活率的提升进展缓慢。尽管有减少新生儿死亡率的有效措施的相关证据，但在卫生系统薄弱的情况下，如何有效地实施干预措施，相关知识却十分有限。在尼泊尔和印度的农村地区，利用妇女团体开展社区动员的群组随机试验显示，新生儿死亡率大幅降低。孟加拉国的一项类似试验则未显示出影响。一个主要假设是，这一负面结果是由于孟加拉国干预人群中妇女团体的覆盖范围远低于印度和尼泊尔。对于循证决策而言，重要的是要检验妇女团体的覆盖范围是否是其影响的主要决定因素。本研究旨在检验高人群覆盖的参与式妇女团体干预对新生儿和产妇健康结果的影响。
将在孟加拉国 3 个农村地区开展参与式妇女团体干预的群组随机试验。由于我们旨在研究高人群覆盖的妇女团体干预，因此将使用与 2005-2007 年试验相同的 9 个干预和 9 个对照联盟。这些联盟是按照地区作为分层随机分配的。为了增加覆盖范围，除了之前试验中包含的 162 个现有团体之外，还另外组建了 648 个新团体。在确定分娩或死亡所在联盟中永久性居住的妇女组成开放队列。在分娩后或如果妇女在怀孕期间死亡，则将其新生儿和妇女纳入研究。排除分娩或死亡所在联盟中临时居住的妇女。主要结局是研究最后 24 个月的新生儿死亡率。将使用低成本监测系统记录研究人群中生育年龄妇女的所有分娩结局和死亡。通过访谈收集家庭护理实践和卫生保健使用的数据。
ISRCTN: ISRCTN01805825。
