Abstract

Background The spread of resistance to SP across Africa threatens the usefulness of intermittent preventive treatment of malaria in pregnancy with sulfadoxine-pyrimethamine (IPTp-SP) in West Africa. There is need for an alternative drug for IPTp or an alternative strategy for delivery of drug-based prevention of MiP. This trial, investigated, whether screening pregnant women for malaria using a rapid diagnostic test (RDT) at antenatal clinic and treating those with positive results with artemether-lumefantrine (Intermittent Screening and Treatment) is as effective and as safe as IPTp-SP. Methods: Between October 2013 and November 2014, 460 pregnant women attending antenatal clinic in Calabar Southeast Nigeria were randomised to either IPTp-SP or intermittent screening and treatment with artemether-lumefantrine (ISTp-AL). All women received a long-lasting insecticide-treated net at enrolment. Study women had a maximum of four scheduled visits following enrolment. Haemoglobin concentration and peripheral parasitaemia were assessed in the third trimester (36-40 weeks gestation). Birth weights were measured at delivery or within six days for babies delivered at home. In addition, the prevalence of molecular markers of resistance to SP among pregnant women was established. Results: In the third trimester, the overall prevalence of severe anaemia (Hb<8 g/dl) and moderate anaemia (8 -10.9 g/dl) was 0.8% and 27.7% respectively and was similar in both groups (p=0.204). The risk of severe anaemia did not differ significantly between both groups (risk difference -1.75% [95% CI; -4.16 to 0.66]. The risk of parasitaemia was considerably lower in the ISTp-AL arm (risk difference -3.96% [95% CI -7.76 to -0.16]). The risk of low birthweight was significantly lower in the ISTp-AL arm after controlling for maternal age, gravidity and baseline parasitaemia (risk difference -1.53% [95% CI; -1.54 to -1.51]). Complaints of fever were more frequent in the ISTp-AL arm (p=0.022). The prevalence of the triple Pfdhfr mutation and the A437G/A581G mutations were very high among malaria positive women. Conclusions: The trial results suggest that in this area of high and perennial malaria transmission with moderate sulfadoxine-pyrimethamine resistance, ISTp with AL may be an effective strategy for controlling malaria in pregnancy.