Safety of artemisinins during early pregnancy, assessed in 62 Sudanese women.

Between June 2006 and October 2008, the safety of artemisinins during early human pregnancy was assessed in central-eastern Sudan. Pregnant women in the first or second trimester who were attending antenatal-care clinics at the Wad Medani, Gadarif and New Halfa hospitals were interviewed. Each was asked if they had had malaria in the first trimester of the index pregnancy and, if so, what treatment they had received. The women who had received artemisinins were then followed-up until delivery and their babies were followed-up until they were 1-year-olds. Overall, 62 of the pregnant women reported receiving artemisinins - artemether injections (48), artesunate plus sulfadoxine-pyrimethamine (11) or artemether plus lumefantrine (three) - during the first trimester. Medical records were available for 51 (82%) of these 62 women, and, in each case, these records showed the reported treatment and that malaria had been confirmed. Only nine (15%) of the 62 women given artemisinins had not known that they were pregnant when treated. Two of the treated women (both given artemether injections in the first trimester) had miscarriages, one at 20 weeks of gestation and the other at 22 weeks, each while receiving quinine infusions for a second attack of malaria. The other 60 women who had received artemisinins delivered apparently healthy babies at full term. No congenital malformations were detected, there was no preterm labour, no maternal deaths were recorded during the follow-up, and none of the babies died during their first year of life. It therefore appears that artemisinins may be safe to use during early pregnancy, although further study is clearly needed.