The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial

Houweling et al. Trials 2011, 12:208 http://www.trialsjournal.com/content/12/1/208 STUDY PROTOCOL TRIALS Open Access The effect of participatory women’s groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial Tanja AJ Houweling1*, Kishwar Azad2, Layla Younes1, Abdul Kuddus2, Sanjit Shaha2, Bedowra Haq2, Tasmin Nahar2, James Beard1, Edward F Fottrell1, Audrey Prost1 and Anthony Costello1, for the PCP study team Abstract Background: 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. Methods: 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. Trial registration: ISRCTN: ISRCTN01805825 Keywords: cluster randomised trial, neonatal mortality, community participation, Bangladesh, women’s groups Background The public health importance of addressing neonatal mortality Every year, 4 million babies die within the first 28 days of life [1]. Another 3 million babies are stillborn, among whom 1 million die during birth [2]. In addition, * Correspondence: 1 UCL Centre for International Health and Development, Institute of Child Health, 30 Guildford Street, London WC1N 1EH, UK Full list of author information is available at the end of the article between 343,000 and 500,000 women die during pregnancy, labour or 42 days post-partum [3,4]. Nearly all of these deaths occur in low and middle income countries. The faster reductions in post-neonatal and child mortality relative to neonatal mortality during the last decades [1] have increased the importance of improving newborn survival to achieve Millennium Development Goal (MDG) 4 (to reduce under-five mortality by two-thirds between 1990 and 2015) [5,6]. Currently, 42% of under- © 2011 Houweling et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Houweling et al. Trials 2011, 12:208 http://www.trialsjournal.com/content/12/1/208 5 deaths occur during the first 28 days of life [2], of which 25-45% within the first 24 hours [1]. While neonatal, and in particular early neonatal, mortality has been relatively resistant to change [1], effective interventions are known for both home and health care settings [7,8]. They include skilled antenatal and delivery care as well as safe home care such as clean delivery practices, breastfeeding and prevention of hypothermia [8]. The scant progress in neonatal survival is contributed to by a lack of evidence on how to deliver effective interventions in contexts where health systems are weak. Every year 60 million women deliver without skilled assistance [9], and maternity care is extremely unequally distributed, with a minority of poor women having access to such care in most low and middle income countries [10]. Evidence is needed on how to improve newborn survival in such contexts. Newborn health in Bangladesh While Bangladesh is on track to achieve MDG4 [11], its burden of neonatal mortality is high. It is the 6th country worldwide with the highest number of neonatal deaths [7]. Around 57% of under-5 deaths in Bangladesh occur in the first month of life [12], of which 74-83% die in the first week [13-15]. About 37 out of 1,000 babies that are born alive die within the first 28 days of life, with infections, low birth weight, and birth asphyxia being the main causes of death [14]. While 60% of pregnant Bangladeshi women make at least one antenatal care visit [12], only 18% of births (13% in rural areas) are assisted by a medically trained provider. This is the lowest coverage worldwide, apart from Ethiopia, Afghanistan and Chad [16]. The vast majority of births (89% in rural areas) is delivered at home, mostly with the assistance of a traditional birth attendant [12]. Government policy on maternal, newborn and child health of newly independent Bangladesh initially focussed on the Expanded Programme on Immunisation, which includes immunisation against tetanus. This led to a major reduction in neonatal tetanus during the late 1970s and 1980s [14]. It was followed in 1998 by the adoption of the Integrated Management of Childhood Illness (IMCI) strategy [17], which, in Bangladesh, includes children from birth till 5 years of age. While IMCI is now in place in most sub-districts, problems remain with the provision of services. In 2009, a National Neonatal Health Strategy and Technical Guidelines have been developed under the stewardship of the Ministry of Health and Family Welfare, underscoring the Government of Bangladesh’s commitment to achieve MDG4 [18]. They include recommendations on normal newborn care, neonatal sepsis, low birth weight babies, birth asphyxia, and maternal health. Another national programme geared to reduce maternal as well as Page 2 of 11 neonatal mortality in Bangladesh is the Community Skilled Birth Attendants Programme, in which a cadre of community health workers is being trained (...truncated)