Status:
COMPLETED
Intermittent Preventive Treatment During Pregnancy in Benin
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
National Malaria Control Program, Benin
Ministry of Foreign Affairs, France
Conditions:
Malaria
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 Preventiv...
Detailed Description
The trial will be conducted in two maternity clinics in Ouidah, 40km from Cotonou. A total of 1600 women will be selected and randomised to receive either SP (1500 mg sulfadoxine with 75 mg pyrimetham...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00274235
Start Date
July 1 2005
End Date
April 1 2008
Last Update
October 31 2008
Active Locations (1)
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1
Institut de Recherche pour le Développement
Cotonou, Benin, 01 BP 4414 RP