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

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

Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).

BACKGROUND: Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival and the effect of out-of-school-hours teaching on children's literacy and numeracy in rural Madhya Pradesh. METHODS/DESIGN: This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The clusters are 196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention. The participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation. The participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020. DISCUSSION: In CHAMPION2, the NICE Foundation will deliver a 3.5-year programme comprising Accredited Social Health Activists or village health workers and midwives promoting health knowledge and providing antenatal, postnatal, and neonatal healthcare; community mobilisation; referrals to appropriate government health facilities; and a health education campaign. In STRIPES2, the Pratham Education Foundation will deliver a programme of village-based, before/after school support focusing on literacy and numeracy. As controls, the CHAMPION2 control villages will receive the usual health services (plus the STRIPES2 intervention). STRIPES2 control villages will receive the usual education services (plus the CHAMPION2 intervention). The primary outcome in CHAMPION2 is neonatal mortality. Secondary outcomes include antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness. The primary outcome in STRIPES2 is a composite literacy and numeracy test score. Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness. Independent research and implementation teams will conduct the trial. Trial Steering and Data Monitoring Committees, with independent members, will supervise the trial. TRIAL REGISTRATION: Clinical Trial Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27

Socioeconomic Inequalities in Newborn Care During Facility and Home Deliveries: A Cross Sectional Analysis of Data from Demographic Surveillance Sites in Rural Bangladesh, India and Nepal

Background: In Bangladesh, India and Nepal, neonatal outcomes of poor infants are considerably worse than those of better-off infants. Understanding how these inequalities vary by country and place of delivery (home or facility) will allow targeting of interventions to those who need them most. We describe socio-economic inequalities in newborn care in rural areas of Bangladesh, Nepal and India for all deliveries and by place of delivery. Methods: We used data from surveillance sites in Bangladesh, India and from Makwanpur and Dhanusha districts in Nepal, covering periods from 2001 to 2011. We used literacy (ability to read a short text) as indicator of socioeconomic status. We developed a composite score of nine newborn care practices (score range 0–9 indicating infants received no newborn care to all nine newborn care practices). We modeled the effect of literacy and place of delivery on the newborn care score and on individual practices. Results: In all study sites (60,078 deliveries in total), use of facility delivery was higher among literate mothers. In all sites, inequalities in newborn care were observed: the difference in new born care between literate and illiterate ranged 0.35–0.80. The effect of literacy on the newborn care score reduced after adjusting for place of delivery (range score difference literate-illiterate: 0.21–0.43). Conclusion: Socioeconomic inequalities in facility care greatly contribute to inequalities in newborn care. Improving newborn care during home deliveries and improving access to facility care are a priority for addressing inequalities in newborn care and newborn mortality

Improving Newborn Survival in Low-Income Countries: Community-Based Approaches and Lessons from South Asia

David Osrin and colleagues discuss the critical importance of reducing global neonatal mortality in developing countries and how community-based approaches can help

Association between clean delivery kit use, clean delivery practices, and neonatal survival: pooled analysis of data from three sites in South Asia

Sepsis accounts for up to 15% of an estimated 3.3 million annual neonatal deaths globally. We used data collected from the control arms of three previously conducted cluster-randomised controlled trials in rural Bangladesh, India, and Nepal to examine the association between clean delivery kit use or clean delivery practices and neonatal mortality among home births