[Randomized clinical trial of two malaria prophylaxis regimens for pregnant women in Faladie, Mali]

From June 2003 to May 2004 we carried out a comparative study of two malaria prophylaxis regimens for pregnant women. The purpose was to compare the efficacy of two regimens using chloroquine (CQ) or sulfadoxine-pyrimethamine (SP) during pregnancy and delivery in a village located in an endemic area of Mali. The study was carried out in Faladié (District of Kati) located 80 km from Bamako. Prophylaxis was administered during the second and third trimesters of pregnancy (except the 9th month for SP). A total of 301 pregnant women were enrolled including 150 in the CQ group and 151 in the SP group. At the onset of the study, the two groups were comparable with regard to socio-demographic and malaria factors. At the time of delivery, malaria infection was reduced by 43.3% in the CQ group (P < 10-6), and by 79.1% in the SP group (p < 10-6). The anemia rate was reduced by 57.5% in the CQ group (Ch2 of McNemar = 0.017), and by 74.8% in the SP group (Ch2 of McNeamar = 0.025). The incidence of placental infection was 20.6 % in the CQ group versus 8.3 % in the SP group (p = 4.10-3). Overall 16.7% of newborns presented low birth weight at delivery including 70.4% in the CQ group. The findings of this study suggest that intermittent presumptive treatment using SP is more effective than intermittent presumptive treatment using CQ in protecting both the mother and newborn against intra-uterine malaria transmission and its consequences.