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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730366 on ClinicalTrials.gov