Intermittent Preventive Treatment During Pregnancy in Benin
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborators:
Faculté des Sciences de la Santé, Bénin Institut des Sciences Biomédicales Appliquées, Bénin Ministry of Foreign Affairs, France National Malaria Control Program, Benin
Treatments:
Fanasil, pyrimethamine drug combination Mefloquine Pyrimethamine Sulfadoxine