RecruitingACTRN12612000588897

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

A community-based cluster randomized 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

Sponsor

The University of Sydney

Enrollment

32,000 participants

Start Date

Jul 23, 2013

Study Type

Interventional

Conditions

Preterm delivery Low birthweight

Summary

BACKGROUND In rural Bangladesh neonatal mortality remains unacceptably high, and the current rate of decline will be insufficient for the country to reach its child survival Millennium Development Goal (MDG). An effective program of antenatal iron/folic acid supplementation in pregnant women in Bangladesh may be a key intervention to help accelerate the needed decline in neonatal mortality. AIMS The study aims to collect high-level evidence of whether enhanced distribution of iron-folic acid to women early in pregnancy in rural Bangladesh can improve perinatal outcomes for the infant. Specifically, the aims of the trial are to evaluate if iron-folic acid supplementation starting in the first trimester of pregnancy and sustained throughout pregnancy: i) Reduces neonatal mortality including deaths related to preterm delivery and birth asphyxia? ii) Reduces rates of low birth weight and preterm delivery? iii) Is cost effective compared to the usual supplementation program? PRIMARY HYPOTHESIS In a cluster randomized controlled trial (CRCT) of women from rural Bangladesh, daily iron (60mg)/folic acid (400µg) starting in the 1st trimester of pregnancy, & sustained for at least 180 days, will reduce neonatal mortality by 30% from 33/1000 to 23.2/1000 live births compared to usual supplementation programs. RESEARCH PLAN The trial will be conducted in 4 districts (depending upon availability of sufficient BRAC field workers), where BRAC, Bangladesh’s largest NGO, currently has community programs. A CRCT will be used, in which BRAC field worker areas (SK), will be randomly allocated to an enhanced iron/folic acid, or to usual programs. In total 202 clusters will be randomized, with equal numbers per treatment group, giving a sample of 20,000 live births in 30 months. In intervention areas trained field workers will identify pregnant women & provide iron/folic acid in the 1st trimester, resupply supplements fortnightly, & provide counselling for early and continued use of supplements until delivery. The primary outcome will be changes in the neonatal mortality rate in the intervention & comparison areas in a large scale cohort follow up of women registered in the trial using direct records of neonatal deaths. Secondary outcomes will include the percentage of women using iron/folic acid in the 1st trimester, the rates of low birth weight & preterm delivery, percentage of neonatal deaths attributable to preterm delivery & birth asphyxia. These outcomes will be assessed in an intensively followed up cohort of women followed during pregnancy until 6 weeks after birth. OUTCOME AND SIGNIFICANCE This project will determine if antenatal iron-folic acid from early in pregnancy will reduce neonatal deaths, & if this approach is cost-effective. This intervention potentially offers a new way to accelerate reductions in neonatal deaths that could save millions of lives.

Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This large study in rural Bangladesh is testing whether starting iron and folic acid supplements early in pregnancy (during the first three months) and continuing throughout pregnancy can reduce deaths in newborns. Iron and folic acid are important nutrients for a developing baby, and getting them early may prevent problems like preterm birth and low birth weight that contribute to newborn deaths. Community health workers will identify pregnant women and provide supplements and support regularly during pregnancy. You may be eligible if: - You are a pregnant woman living in one of the study areas in rural Bangladesh - You are in your first trimester of pregnancy (for the intensive follow-up component, no more than 16 weeks pregnant) You may NOT be eligible if: - You live in a cluster (area) where other programs are already distributing iron and folic acid - You live in an area that is extremely difficult to access due to flooding - You are more than 16 weeks pregnant (for the intensively followed cohort only) Talk to your doctor or community health worker about whether this trial might be right for you.

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Interventions

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.

Locations(1)

Dhaka Division, Bangladesh

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ACTRN12612000588897