Gestational malaria in Kisangani : Efficacy of Mefloquine vs Sulfadoxine-Pyrimethamine in Intermittent Preventive Treatment : A Study Protocol for a randomized controlled clinical trial

Abstract

Background : In order to reduce malaria-related morbidity and mortality during pregnancy, WHO recommends : Insecticide-treated mosquito nets, Intermittent Preventive Treatment of malaria in pregnancy, Prompt and effective case management. Nevertheless, several cases of resistance to Sulfadoxine-Pyrimethamine, used in intermittent preventive treatment, and to Chloroquine are reported in sub-Saharan Africa and in the Democratic Republic of the Congo. The prevalence of malaria among pregnant women remains high in Africa in general, and in the Democratic Republic of Congo in particular. This issue leads us to conduct this study, which aims at proposing an alternative to SP for preventing malaria in pregnant women. Materials and methods : From June 1 to October 31, 2019, we enrolled pregnant women from five health facilities in Kisangani for randomized, single-blind controlled clinical trials to compare the efficacy of two intermittent preventive treatment regimens in Kisangani pregnant women, selected before 18 th weeks of amenorrhea. The first regimen consists of 4 doses of Sulfadoxine-Pyrimethamine starting at the selection time and spaced at least 4 weeks during pregnancy. Each dose is made of 3 tablets of 525 mg Sulfadoxine-Pyrimethamine. The second regimen consists of 2 doses of Mefloquine during pregnancy. The first dose is taken at the selection time and the second dose between the 28 th and 32 nd weeks of amenorrhea. Each dose is made of 3 tablets of 250 mg Mefloquine. The efficacy criteria for these two regimens are placental malaria parasitemia, low birth weight of newborn and maternal anemia at delivery. The safety criterion was the occurrence of major side effects. Discussion : There are not enough randomized clinical trials assessing the efficacy of Mefloquine for the intermittent preventive treatment of malaria in African pregnant women, hence the recommendation for clinical trials. The present study is the only one that conducts such assessment in a hyper-endemic area with resistance to Sulfadoxine-Pyrimethamine and Chloroquine. The findings are therefore intended to promote the use of Mefloquine as the best alternative to Sulfadoxine-Pyrimethamine in the intermittent preventive treatment of malaria. Clinical trial registration : PACTR201905899965726. Key words : Intermittent preventive treatment, efficacy, safety, Mefloquine, Sulfadoxine-Pyrimethamine, Kisangani.