[Pharmacovigilance and impact of intermittent preventive treatment with sulfadoxine-pyrimethamine in pregnant women in Sélingué, Mali].

This study aimed to evaluate the impact of intermittent preventive treatment (IPT) and the associated adverse effects in pregnant women living in hyperendemic area of Sélingué in Mali on pregnancy outcome. Pharmacovigilance aims, monitoring the risk of adverse effects resulting from the use of drugs and products for human use licensees of marketing. IPT with sulfadoxine-pyrimethamine (SP) is based on the administration of 2 doses of SP treatment in pregnant women at defined intervals after about 18-20 weeks of pregnancy. The survey on attitudes and behavioural practices (KAP) has allowed us to interview 210 pregnant women attending antenatal clinics at the health district of Sélingué. Almost all women (99%) affirm to know malaria and 84.8% to know clinical signs of malaria. Self medication was practiced by 40% of the expectant mothers. A small proportion of women affirm to have mosquito nets (8.6%) while 14.3% affirm to use impregnated insecticide mosquito nets. The rate of severe anaemia was 30.5% (Hb < 7 g/dl) after the first dose and 13.3% after the second dose of S-P. In parallel, the rate of moderate anaemia (Hb 7-9g /dl) decreased by 54.8% after the first dose to 26.2% after the second dose. Anaemia was higher within multigestes (32.1%) compared with the primigestes (21.7%). We did not observe any case of therapeutic failure with S-P nor infection in our study. The rate of prematurity was 3% while the rate low birth weight was 17.6%. Observed adverse reactions were primarily nauseas and stomach upset (1.9% after first S-P dose and 1% after the 2nd dose of S-P). No case of severe side effects or malformations was observed within new-born babies. In conclusion, IPT with S-P was well tolerated by pregnant women living in Sélingué and presents very few minor secondary reactions. The S-P is currently the only antimalarial drug with a single-dose which has a prolonged action and which also has ideal properties (low cost, several data on its tolerance and its facility of use) for a better use during the pregnancy in Africa.