Intermittent Preventive Treatment During Pregnancy in Benin

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Pregnancy between 16 and 28 weeks of gestation

• Residence near the maternity clinics

• Intention to continue the ante-natal care and deliver at the study maternity clinic

• Ability to take drugs by oral route

• Written informed consent (parents or guardian if aged < 18 years)

Exclusion Criteria:

• Pregnancy prior to 16 weeks or after 28 weeks of gestation

• Previous suspected reaction to sulfadoxine-pyrimethamine or mefloquine

• History of neurological or psychiatric event

• Intake of sulfadoxine-pyrimethamine or mefloquine within 4 weeks of enrollment

• Current treatment with halofantrine