A Randomised, Placebo Controlled Trial of Intermittent Preventative Treatment With Sulfadoxine-pyrimethamine in Gambian Multigravidae.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Hemoglobin concentration at delivery.
Study Overview
Brief Summary
Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth weight which, in turn, increases infant mortality. Thus, the World Health Organization (WHO) now recommends that all pregnant women who live in malaria endemic areas of Africa should receive sulfadoxine-pyrimethamine (SP) at monthly intervals during the second and third trimesters of pregnancy. Malaria is especially severe during first pregnancies and the value of intermittent preventative treatment with SP during first pregnancies has been clearly shown. However, it is less certain whether multigravidae, who are at less risk, also benefit from intermittent preventative treatment with SP. To investigate this, a trial has been conducted in Gambian multigravidae who were given intermittent preventative treatment with SP or placebo during the second and third trimesters. The prevalence of anemia six weeks after delivery, low birth weight and poor outcome of pregnancy in women in each group were studied.
Detailed Description
Objective
The objective of this study was to determine whether intermittent preventative treatment (IPTp) with sulfadoxine-pyrimethamine (SP) reduced the prevalence of anemia and low birth weight in Gambian multigravidae.
Study area
The study was carried out in 14 mother and child health (MCH) clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country. In this area, malaria is highly seasonal with an entomological inoculation rate of 10 -50 infectious bites per year.
Study population
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Multigravid pregnancy.
- •Residence in study area.
- •Informed consent.
Exclusion Criteria
- •Allergy to sulfonamides.
- •Chronic illness.
Outcomes
Primary Outcomes
Hemoglobin concentration at delivery.
Birthweight.
Secondary Outcomes
- Hemoglobin concentration six weeks after delivery.
Investigators
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine