A trial to evaluate the impact of an early start to iron/folic acid supplementation in pregnancy on deaths of newborns in rural Bangladesh

INTERVENTION: In the intervention clusters trained BRAC (Bangladesh Rural Advancement Committee, an NGO based in Bangladesh) village volunteers will identify pregnant women and provide consenting women with a daily dose of iron (60 mg)/folic acid (400ug) supplementation early in pregnancy (in the first trimester) to be taken orally and sustained for at least 180 days, ensure resupply of supplements through fortnightly visits, and provide counselling in support of early uptake, continued use of the supplements until delivery, and compliance with the supplementation regime. This intervention is consistent with the Bangladesh Ministry of Health guidelines. To achieve early contact with the women in pregnancy the BRAC village volunteers will identify pregnant women through routine surveillance visits to the households in their area every month. In all clusters the BRAC village field workers will identify the pregnancy outcomes, the deaths of the neonates and mothers, and inform the study assistants who will make a visit and confirm these events and collect other details. Both intervention and control treatment arms will receive the usual antenatal and postnatal care services provided by the Bangladesh Ministry of Health, which are supported by the BRAC Essential Health Care program. CONDITION: Iron deficiency Low birthweight Neonatal mortality Preterm delivery PRIMARY OUTCOME: All infant deaths occurring in the first month of life assessed by the data collected by the trained research field worker visits. SECONDARY OUTCOME: Mean marginal additional expenditure associated with early iron/folic acid supplementation, and the mean cost per neonatal death prevented referring to health service costs. Percentage of live births with low birthweight (weighing <2500g) (intensive). Percentage of live births with preterm delivery (intensive). Preterm delivery is defined as a birth occurring with gestational age before 37 weeks of gestation and includes early preterm delivery (<34 weeks) based on maternal report of the date of last menstrual period (LMP). Percentage of neonatal deaths attributable to preterm delivery asphyxia. Percentage of neonatal deaths attributable to preterm delivery. Percentage of women using iron/folic acid as prescribed in the first trimester of pregnancy assessed by data collected by trained research field worker visits. INCLUSION CRITERIA: All pregnant women registered in the study clusters.