Kishwar Azad

Effect of scaling up women's groups on birth outcomes in three rural districts in Bangladesh: a cluster-randomised controlled trial

BACKGROUND Two recent trials have shown that womens groups can reduce neonatal mortality in poor communities. We assessed the effectiveness of a scaled-up development programme with womens groups to address maternal and neonatal care in three rural districts of Bangladesh. METHODS 18 clusters (with a mean population of 27 953 [SD 5953]) in three districts were randomly assigned to either intervention or control (nine clusters each) by use of stratified randomisation. For each district, cluster names were written on pieces of paper, which were folded and placed in a bottle. The first three cluster names drawn from the bottle were allocated to the intervention group and the remaining three to control. All clusters received health services strengthening and basic training of traditional birth attendants. In intervention clusters, a facilitator convened 18 groups every month to support participatory action and learning for women, and to develop and implement strategies to address maternal and neonatal health problems. Women were eligible to participate if they were aged 15-49 years, residing in the project area, and had given birth during the study period (Feb 1, 2005, to Dec 31, 2007). Neither study investigators nor participants were masked to treatment assignment. In a population of 229 195 people (intervention clusters only), 162 womens groups provided coverage of one group per 1414 population. The primary outcome was neonatal mortality rate (NMR). Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN54792066. FINDINGS We monitored outcomes for 36 113 births (intervention clusters, n=17 514; control clusters, n=18 599) in a population of 503 163 over 3 years. From 2005 to 2007, there were 570 neonatal deaths in the intervention clusters and 656 in the control clusters. Cluster-level mean NMR (adjusted for stratification and clustering) was 33.9 deaths per 1000 livebirths in the intervention clusters compared with 36.5 per 1000 in the control clusters (risk ratio 0.93, 95% CI 0.80-1.09). INTERPRETATION For participatory womens groups to have a significant effect on neonatal mortality in rural Bangladesh, detailed attention to programme design and contextual factors, enhanced population coverage, and increased enrolment of newly pregnant women might be needed. FUNDING Women and Children First, the UK Big Lottery Fund, Saving Newborn Lives, and the UK Department for International Development.

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications

BackgroundPublic health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters. This needs to be taken into account in sample size estimations for planned trials, but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community. In this study we report estimates for perinatal health outcomes from community-based trials to help researchers plan future evaluations.MethodsWe estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster randomised controlled trials in three low-income countries: India, Bangladesh and Malawi. We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes.ResultsEstimates of intracluster correlation for mortality outcomes were lower than those for process outcomes, with narrower confidence intervals throughout for trials with larger numbers of clusters. Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals. Stratified randomisation had the effect of reducing estimates of intracluster correlation. The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality. The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes.ConclusionsThe breadth of intracluster correlation estimates reported here in terms of outcomes and contexts will help researchers plan future community-based public health interventions around maternal and newborn health. Our study confirms previous work finding that estimates of intracluster correlation are associated with the prevalence of the outcome of interest, the nature of the outcome of interest (mortality or behavioural) and the size and number of clusters. Estimates of intracluster correlation for maternal mortality need to be treated with caution and a range of estimates should be used in planning future trials.

Prevalence and determinants of caesarean section in private and public health facilities in underserved South Asian communities: cross-sectional analysis of data from Bangladesh, India and Nepal

Objectives To describe the prevalence and determinants of births by caesarean section in private and public health facilities in underserved communities in South Asia. Design Cross-sectional study. Setting 81 community-based geographical clusters in four locations in Bangladesh, India and Nepal (three rural, one urban). Participants 45 327 births occurring in the study areas between 2005 and 2012. Outcome measures Proportion of caesarean section deliveries by location and type of facility; determinants of caesarean section delivery by location. Results Institutional delivery rates varied widely between settings, from 21% in rural India to 90% in urban India. The proportion of private and charitable facility births delivered by caesarean section was 73% in Bangladesh, 30% in rural Nepal, 18% in urban India and 5% in rural India. The odds of caesarean section were greater in private and charitable health facilities than in public facilities in three of four study locations, even when adjusted for pregnancy and delivery characteristics, maternal characteristics and year of delivery (Bangladesh: adjusted OR (AOR) 5.91, 95% CI 5.15 to 6.78; Nepal: AOR 2.37, 95% CI 1.62 to 3.44; urban India: AOR 1.22, 95% CI 1.09 to 1.38). We found that highly educated women were particularly likely to deliver by caesarean in private facilities in urban India (AOR 2.10; 95% CI 1.61 to 2.75) and also in rural Bangladesh (AOR 11.09, 95% CI 6.28 to 19.57). Conclusions Our results lend support to the hypothesis that increased caesarean section rates in these South Asian countries may be driven in part by the private sector. They also suggest that preferences for caesarean delivery may be higher among highly educated women, and that individual-level and provider-level factors interact in driving caesarean rates higher. Rates of caesarean section in the private sector, and their maternal and neonatal health outcomes, require close monitoring.

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

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 womens 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 womens groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if womens 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 womens group intervention with a high population coverage of womens groups.MethodsA cluster randomised trial of a participatory womens group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a womens 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

Scaling up community mobilisation through women's groups for maternal and neonatal health: Experiences from rural Bangladesh

BackgroundProgram coverage is likely to be an important determinant of the effectiveness of community interventions to reduce neonatal mortality. Rigorous examination and documentation of methods to scale-up interventions and measure coverage are scarce, however. To address this knowledge gap, this paper describes the process and measurement of scaling-up coverage of a community mobilisation intervention for maternal, child and neonatal health in rural Bangladesh and critiques this real-life experience in relation to available literature on scaling-up.MethodsScale-up activities took place in nine unions in rural Bangladesh. Recruitment and training of those who deliver the intervention, communication and engagement with the community and other stakeholders and active dissemination of intervention activities are described. Process evaluation and population survey data are presented and used to measure coverage and the success of scale-up.ResultsThe intervention was scaled-up from 162 womens groups to 810, representing a five-fold increase in population coverage. The proportion of women of reproductive age and pregnant women who were engaged in the intervention increased from 9% and 3%, respectively, to 23% and 29%.ConclusionsExamination and documentation of how scaling-up was successfully initiated, led, managed and monitored in rural Bangladesh provide a deeper knowledge base and valuable lessons.Strong operational capabilities and institutional knowledge of the implementing organisation were critical to the success of scale-up. It was possible to increase community engagement with the intervention without financial incentives and without an increase in managerial staff. Monitoring and feedback systems that allow for periodic programme corrections and continued innovation are central to successful scale-up and require programmatic and operational flexibility.

Intrapartum-Related Stillbirths and Neonatal Deaths in Rural Bangladesh: A Prospective, Community-Based Cohort Study

OBJECTIVE: Using a low-cost community surveillance system, we aimed to estimate intrapartum stillbirth and intrapartum-related neonatal death rates for a low-income community setting. PATIENTS AND METHODS: From 2005 to 2008, information on all deliveries in 18 unions of 3 districts of Bangladesh was ascertained by using traditional birth attendants as key informants. Outcomes were measured using a structured interview with families 6 weeks after delivery. RESULTS: We ascertained information on 31 967 deliveries, of which 26 173 (82%) occurred at home. For home deliveries, the mean cluster-adjusted stillbirth rate was 26 (95% confidence interval [CI[: 24–28) per 1000 births, and the perinatal mortality rate was 51 per 1000 births (95% CI: 47–55). The NMR was 33 per 1000 live births (95% CI: 30–37). There were 3186 (12.5%) home-born infants who did not breathe immediately. Of these, 53% underwent some form of resuscitation. Of 1435 infants who were in poor condition at 5 minutes (5% of all deliveries), 286 (20%) died; 35% of all causes of neonatal mortality. Of 201 fresh stillbirths, 40 (14%) of the infants had major congenital abnormalities. Our estimate of the intrapartum-related crude mortality rate among home-born infants is 17 in 1000 (95% CI: 16–19), 6 in 1000 stillborn and 11 in 1000 neonatal deaths after difficulties at birth. CONCLUSIONS: Difficulty initiating respiration among infants born at home in rural Bangladesh is common, and resuscitation is frequently attempted. Newborns who remain in poor condition at 5 minutes have a 20% mortality rate. Evaluation of resuscitation methods, early intervention trials including antibiotic regimes, and follow-up studies of survivors of community-based resuscitation are needed.

Socio-economic determinants of household food security and women’s dietary diversity in rural Bangladesh: a cross-sectional study

BackgroundThere has been limited decline in undernutrition rates in South Asia compared with the rest of Asia and one reason for this may be low levels of household food security. However, the evidence base on the determinants of household food security is limited. To develop policies intended to improve household food security, improved knowledge of the determinants of household food security is required.MethodsHousehold data were collected in 2011 from a randomly selected sample of 2,809 women of reproductive age. The sample was drawn from nine unions in three districts of rural Bangladesh. Multinomial logistic regression was conducted to measure the relationship between selected determinants of household food security and months of adequate household food provisioning, and a linear regression to measure the association between the same determinants and women’s dietary diversity score.ResultsThe analyses found that land ownership, adjusted relative risk ratio (RRR) 0.28 (CI 0.18, 0.42); relative wealth (middle tertile 0.49 (0.29, 0.84) and top tertile 0.18 (0.10, 0.33)); women’s literacy 0.64 (0.46, 0.90); access to media 0.49 (0.33, 0.72); and women’s freedom to access the market 0.56 (0.36, 0.85) all significantly reduced the risk of food insecurity. Larger households increased the risk of food insecurity, adjusted RRR 1.46 (CI 1.02, 2.09). Households with vegetable gardens 0.20 (0.11, 0.31), rich households 0.46 (0.24, 0.68) and literate women 0.37 (0.20, 0.54) were significantly more likely to have better dietary diversity scores.ConclusionHousehold food insecurity remains a key public health problem in Bangladesh, with households suffering food shortages for an average of one quarter of the year. Simple survey and analytical methods are able to identify numerous interlinked factors associated with household food security, but wealth and literacy were the only two determinants associated with both improved food security and dietary diversity. We cannot conclude whether improvements in all determinants are necessarily needed to improve household food security, but new and existing policies that relate to these determinants should be designed and monitored with the knowledge that they could substantially influence the food security and nutritional status of the population.

The effect of participatory women's groups on infant feeding and child health knowledge, behaviour and outcomes in rural Bangladesh: a controlled before-and-after study

Background Despite efforts to reduce under-5 mortality rates worldwide, an estimated 6.6 million under-5 children die every year. Community mobilisation through participatory womens groups has been shown to improve maternal and newborn health in rural settings, but little is known about the potential of this approach to improve care and health in children after the newborn period. Methods Following on from a cluster-randomised controlled trial to assess the effect of participatory womens groups on maternal and neonatal health outcomes in rural Bangladesh, 162 womens groups continued to meet between April 2010 and December 2011 to identify, prioritise and address issues that affect the health of children under 5 years. A controlled before-and-after study design and difference-in-difference analysis was used to assess morbidity outcomes and changes in knowledge and practices related to child feeding, hygiene and care-seeking behaviour. Findings Significant improvements were measured in mothers’ knowledge of disease prevention and management, danger signs and hand washing at critical times. Significant increases were seen in exclusive breast feeding for at least 6 months (15.3% (4.2% to 26.5%)), and mean duration of breast feeding (37.9 days (17.4 to 58.3)). Maternal reports of under-5 morbidities fell in intervention compared with control areas, including reports of fever (−10.5% (−15.1% to −6.0%)) and acute respiratory infections (−12.2% (−15.6% to −8.8%)). No differences were observed in dietary diversity scores or immunisation uptake. Conclusions Community mobilisation through participatory womens groups can be successfully adapted to address health knowledge and practice in relation to childs health, leading to improvements in a number of child health indicators and behaviours.

Cause-specific neonatal mortality: analysis of 3772 neonatal deaths in Nepal, Bangladesh, Malawi and India

Objective Understanding the causes of death is key to tackling the burden of three million annual neonatal deaths. Resource-poor settings lack effective vital registration systems for births, deaths and causes of death. We set out to describe cause-specific neonatal mortality in rural areas of Malawi, Bangladesh, Nepal and rural and urban India using verbal autopsy (VA) data. Design We prospectively recorded births, neonatal deaths and stillbirths in seven population surveillance sites. VAs were carried out to ascertain cause of death. We applied descriptive epidemiological techniques and the InterVA method to characterise the burden, timing and causes of neonatal mortality at each site. Results Analysis included 3772 neonatal deaths and 3256 stillbirths. Between 63% and 82% of neonatal deaths occurred in the first week of life, and males were more likely to die than females. Prematurity, birth asphyxia and infections accounted for most neonatal deaths, but important subnational and regional differences were observed. More than one-third of deaths in urban India were attributed to asphyxia, making it the leading cause of death in this setting. Conclusions Population-based VA methods can fill information gaps on the burden and causes of neonatal mortality in resource-poor and data-poor settings. Local data should be used to inform and monitor the implementation of interventions to improve newborn health. High rates of home births demand a particular focus on community interventions to improve hygienic delivery and essential newborn care.