At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
In Brief
A Phase 3 clinical trial evaluating Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy and Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy for Malaria. Completed, enrolled 782 participants across 1 site.
Detailed Summary
This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of two intermittent preventive treatment in pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. All children born to mothers enrolled in the study will be followed from birth until they reach 12 months of age.