New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa
NCT00730366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2766
Last updated 2010-09-14
Summary
Malaria in pregnancy contributes substantially to maternal anaemia and low birth weight: effective malaria control in pregnancy could avoid about 10,000 maternal and up to 200,000 infant deaths every year. Intermittent preventive treatment with the drug sulfadoxine-pyrimethamine (IPTp-SP), administered at least twice during routine antenatal clinics, is recommended by the World Health Organization for areas of moderate to high malaria transmission, including Sub-Saharan Africa.
Studies carried out in Kenya and Malawi before 2004 had showed that two doses of IPTp-SP significantly reduce maternal anaemia, placental malaria parasitaemia and low birth weight. However, in countries where this strategy had been introduced as part of national policy, the coverage of the target population has varied widely, with estimates of 33-93% for uptake of one dose and 24-68% for two doses, and no country had reached the goal of 80% of pregnant women receiving at least 2 doses of IPTp. New approaches designed to improve IPTp coverage were therefore urgently needed.
This study was therefore set up in 2002, in order to evaluate the additional effect of a targeted promotional campaign on antenatal clinics utilization and on coverage and uptake of Intermittent preventive treatment with sulfadoxine-pyrimethamine in a rural health district in Burkina Faso; and to investigate the effectiveness of intermittent preventive treatment with the sulfadoxine-pyrimethamine compared with weekly chloroquine, in order to provide additional evidence to the Burkinabé Ministry of Health for an impending policy change.
Conditions
- Malaria in Pregnancy
Interventions
- DRUG
-
sulfadoxine-pyrimethamine
Sulfadoxine-pyrimethamine given as intermittent therapy, at the dosage of 1500/75 mg per administration (3 tablets), Twice during pregnancy
- DRUG
-
Chloroquine
Chloroquine tablets 100 mg. First administration of 1500 mg given over three days, followed by weekly doses of 300 mg/week
Sponsors & Collaborators
-
University of Ouagadougou, Burkina Faso
collaborator OTHER -
National Laboratory of Public Health,Burkina Faso
collaborator UNKNOWN -
Liverpool School of Tropical Medicine
collaborator OTHER -
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
collaborator OTHER -
Institute of Tropical Medicine, Belgium
lead OTHER
Principal Investigators
-
Sheick Coulibaly Oumar Coulibaly, MD PhD · Directeur de la Biologie Médicale du Laboratoire National de Santé Publique
-
Umberto D'Alessandro, MD · Institute of Tropical Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2006-10-31
- Completion
- 2006-12-31
Countries
- Burkina Faso
Study Locations
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