A community-based cluster randomised controlled trial in rural Bangladesh to evaluate the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality: the Shonjibon trial.

BACKGROUND: Iron-deficiency is the most common nutritional deficiency globally. Due to the high iron requirements for pregnancy, it is highly prevalent and severe in pregnant women. There is strong evidence that maternal iron deficiency anaemia increases the risk of adverse perinatal outcomes. However, most of the evidence is from observational epidemiological studies except for a very few randomised controlled trials. IFA supplements have also been found to reduce the preterm delivery rate and neonatal mortality attributable to prematurity and birth asphyxia. These results combined indicate that IFA supplements in populations of iron-deficient pregnant women could lead to a decrease in the number of neonatal deaths mediated by reduced rates of preterm delivery. In this paper, we describe the protocol of a community-based cluster randomised controlled trial that aims to evaluate the impact of maternal antenatal IFA supplements on perinatal outcomes. METHODS/DESIGN: The effect of the early use of iron-folic acid supplements on neonatal mortality will be examined using a community based, cluster randomised controlled trial in five districts with 30,000 live births. In intervention clusters trained BRAC village volunteers will identify pregnant women & provide iron-folic acid supplements. Groundwater iron levels will be measured in all study households using a validated test kit. The analysis will follow the intention to treat principle. We will compare neonatal mortality rates & their 95% confidence intervals adjusted for clustering between treatment groups in each groundwater iron-level group. Cox proportional hazards mixed models will be used for mortality outcomes & will include groundwater iron level as an interaction term in the mortality model. DISCUSSION: This paper aims to describe the study protocol of a community based randomised controlled trial evaluating the impact of the use of iron-folic acid supplements early in pregnancy on the risk of neonatal mortality. This study is critical because it will determine if antenatal IFA supplements commenced in the first trimester of pregnancy, rather than later, will significantly reduce neonatal deaths in the first month of life, and if this approach is cost-effective. TRIAL REGISTRATION: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) on 31 May 2012. The registration ID is ACTRN12612000588897 .

Microbial contamination of drinking water from risky tubewells situated in different hydrological regions of Bangladesh.

This study, conducted in 40 selected upazilas covering four hydrological regions of Bangladesh, aimed at determining the risk of selected shallow tubewells (depth<30m) used for drinking purpose (n=26,229). This was based on WHO's sanitary inspection guidelines and identifying the association of sanitary inspection indicators and risk scores with microbiological contamination of shallow tubewells. The main objective of the study was to observe the seasonal and regional differences of microbial contamination and finally reaching a conclusion about safe distance between tubewells and latrines by comparing the contamination of two tubewell categories (category-1: distance ≤10m from nearest latrine; n=80 and category 2: distances 11-20m from nearest latrine; n=80) in different geographical contexts. About 62% of sampled tubewells were at medium to high risk according to WHO's sanitary inspection guidelines, while the situation was worst in south-west region. Microbiological contamination was significantly higher in sampled category-1 tubewells compared to category-2 tubewells, while the number of contaminated tubewells and level of contamination was higher during wet season. About 21% (CI95=12%-30%), 54% (CI95=43%-65%) and 58% (CI95=46%-69%) of water samples collected from category-1 tubewells were contaminated by E. coli, FC, and TC respectively during the wet season. The number of category-1 tubewells having E.coli was highest in the north-west (n=8) and north-central (n=4) region during wet season and dry season respectively, while the level of E.coli contamination in tubewell water (number of CFU/100ml of sample) was significantly higher in north-central region. However, the south-west region had the highest number of FC contaminated category-1 tubewells (n=16 & n=17; respectively during wet and dry season) and significantly a higher level of TC and FC in sampled Category-1 tubewells than north-west, north-central and south-east region, mainly during wet season. Multivariate regression analysis could identified some sanitary inspection indicators, such as tubewell within <10m of latrine, platform absent/broken, pollution source (i.e. household's waste dumping point/poultry/dairy farm) within 10m of tubewell and unimproved sanitation facility which were significantly associated with presence of microbial contaminants in tubewell water (p<0.01). A tubewell with high risk level was associated with a higher chance of having FC and TC in tubewell water than a tubewell with a medium risk during wet season, but no such conclusion could be drawn in case of E.coli contamination. Construction of pit latrine in areas with high water table should be highly discouraged. Raised sealed pits or flush/pour flash to septic tank could be installed considering sanitary inspection criteria. Water should be treated before drinking.