Research Units | 2 - Dem. Rep. of the Congo - Safe Pregnancy Through Malaria Control

Annually, approximately 25 million African women become pregnant and are at risk of Plasmodium falciparum malaria infection during pregnancy. The adverse effects of malaria during pregnancy include increased risk of maternal anemia, low birth weight (LBW) and infant death. The long-term goal of the Safe Pregnancy Through Malaria Control Study is to improve pregnancy outcomes by developing an effective presumptive artesunate/mefloquine combination therapy to prevent malaria in pregnant women. This will be done through the phased implementation of three separate protocols at two large antenatal clinics in the Democratic Republic of Congo. Each protocol will provide critical information that will be used in the development of a safe and efficacious Intermittent Preventive Therapy (IPT) to prevent malaria in pregnant women.

• Protocol 1 is a pharmacokinetic inpatient study of the standard adult dose of orally-administered, 200 mg, single dose artesunate to assess pharmacokinetics and pharmacodynamics in parasitemic pregnant women during the second and third trimester of pregnancy vs.: (1) the same women three months postpartum, and (2) parasitemic non-pregnant women. The objective of this study is to determine dosing strategies for artesunate in pregnant women.
• Protocol 2 is a randomized clinical trial of safety and efficacy of artesunate/mefloquine combinations in pregnant women. The objectives of this study are (1) to establish the safety of mefloquine and mefloquine + artesunate vs. SP in parasitemic pregnant women, as determined by the rate of adverse pregnancy outcomes from the time of enrollment through 24-hours after birth and (2) to determine the efficacy of mefloquine and mefloquine + artesunate vs. SP in parasitemic pregnant women, defined by parasitological or clinical failure following treatment, placental parasitemia, fever clearance time, and parasite clearance time.
• Protocol 3 is a randomized clinical trial of selective presumptive artesunate/mefloquine combination therapy vs. SP to improve pregnancy outcomes. The objective of this study is to determine the effect on birth weight and adverse pregnancy outcomes of presumptive artesunate/mefloquine combination treatment in pregnant Congolese women.