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Intermittent Preventive Treatment During Pregnancy in Benin

NCT00274235 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2008-10-31

No results posted yet for this study

Summary

Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria control during pregnancy in Benin, but the emergence and the spread of resistance to SP justifies the evaluation of alternative anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to SP. The aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum becomes too elevated. Primary endpoint will be the proportion of infants with low birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.

Conditions

Interventions

DRUG

sulfadoxine-pyrimethamine / mefloquine

Sponsors & Collaborators

  • National Malaria Control Program, Benin

    collaborator OTHER_GOV

  • Ministry of Foreign Affairs, France

    collaborator OTHER_GOV

  • Institut des Sciences Biomédicales Appliquées, Bénin

    collaborator UNKNOWN

  • Faculté des Sciences de la Santé, Bénin

    collaborator UNKNOWN

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Michel Cot, MD · Institut de Recherche pour le Developpement

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-03-31
Completion
2008-04-30

Countries

  • Benin

Study Locations

More Related Trials

Entities

Diseases

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 NCT00274235 on ClinicalTrials.gov