• Oumou S Maïga Diakite, Oumou M Maiga, Kassoum Kayentao, Boubacar T Traoré, Abdoulaye Djimde, Bouyagui Traoré, Mouctar Diallo, Mouctar Traoré, Aissata Ongoiba, Didier Doumtabé, Safiatou Doumbo, Mamadou S Traoré, Antoine Dara, Oumar Guindo, Diawara M Karim, Siraman Coulibaly, Flabou Bougoudogo, Feiko O Ter Kuile, Martin Danis, and Ogobara K Doumbo.
• Department of Health System Information, National Directorate of Health, University of Bamako, Bamako, Mali.
• Clin. Infect. Dis. 2011 Aug 1; 53 (3): 215-23.

BackgroundIn 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW).MethodsWe conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints.ResultsAmong the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32-0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32-0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19-0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed.ConclusionsAdding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance.Clinical Trials RegistrationISRCTN 74189211.

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