bc3_ind_final in Novel Strategies to Prevent Malaria and Improve Maternal-Child Health in Africa (PROMOTE II) - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants - Birth Cohort 3

PROMOTE-II Birth Cohort 3 Individual Database
Study Description
In Africa, the only widely available tools for the prevention of malaria in pregnancy are insecticide treated bednets (ITNs) and intermittent preventive therapy (IPTp) with sulfadoxine-pyrimethamine (SP).We will test the hypothesis that IPTp with dihydroartemisinin-piperaquine (DP) -- which has been safely used for the treatment of uncomplicated malaria in pregnancy in studies from Asia -- will significantly reduce the risk of adverse birth outcomes from malaria in pregnancy and burden of malaria in infancy, compared to IPTp with SP (current Uganda Ministry of Health regimen). This will be a double-blinded randomized controlled phase III trial of 782 HIV-uninfected pregnant women in Busia district, Uganda, and the children born to them. HIV-uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of two IPTp treatment arms: 1) monthly SP, or 2) monthly DP. Both interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved in the study. 782 HIV-uninfected pregnant women and the children born to them