Abstract
BackgroundThe efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach.Methods and FindingsAn open, individually randomized, non-inferiority trial of IPTp-SP versus ISTp was conducted in 5,354 primi- or secundigravidae in four West African countries with a low prevalence of resistance to SP (The Gambia, Mali, Burkina Faso and Ghana). Women in the IPTp-SP group received SP on two or three occasions whilst women in the ISTp group were screened two or three times with a RDT and treated if positive for malaria with artemether-lumefantrine (AL). ISTp-AL was non-inferior to IPTp-SP in preventing low birth weight (LBW), anemia and placental malaria, the primary trial endpoints. The prevalence of LBW was 15.1% and 15.6% in the IPTp-SP and ISTp-AL groups respectively (OR = 1.03 [95% CI: 0.88, 1.22]). The mean hemoglobin concentration at the last clinic attendance before delivery was 10.97g/dL and 10.94g/dL in the IPTp-SP and ISTp-AL groups respectively (mean difference: -0.03 g/dL [95% CI: -0.13, +0.06]). Active malaria infection of the placenta was found in 24.5% and in 24.2% of women in the IPTp-SP and ISTp-AL groups respectively (OR = 0.95 [95% CI 0.81, 1.12]). More women in the ISTp-AL than in the IPTp-SP group presented with malaria parasitemia between routine antenatal clinics (310 vs 182 episodes, rate difference: 49.4 per 1,000 pregnancies [95% CI 30.5, 68.3], but the number of hospital admissions for malaria was similar in the two groups.ConclusionsDespite low levels of resistance to SP in the study areas, ISTp-AL performed as well as IPTp-SP. In the absence of an effective alternative medication to SP for IPTp, ISTp-AL is a potential alternative to IPTp in areas where SP resistance is high. It may also have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated.Trial RegistrationClinicalTrials.gov NCT01084213 Pan African Clinical trials Registry PACT201202000272122
Highlights
Malaria infection during pregnancy (MIP) is a threat to both the pregnant woman and her fetus
In the absence of an effective alternative medication to SP for IPTp, ISTp with artemether lumefantrine (ISTp-AL) is a potential alternative to IPTp in areas where SP resistance is high
It may have a role in areas where malaria transmission is low and for the prevention of malaria in HIV positive women receiving cotrimoxazole prophylaxis in whom SP is contraindicated
Summary
Malaria infection during pregnancy (MIP) is a threat to both the pregnant woman and her fetus. Recommended approaches for the control of MIP are provision of effective treatment, insecticide treated bednets and intermittent preventive treatment with sulfadoxinepyrimethamine (IPTp-SP) given at each antenatal clinic (ANC) attendance after the first trimester [1]. IPTp-SP is effective at preventing maternal anemia and low birthweight (LBW) in areas where Plasmodium falciparum is susceptible to SP [2,3,4,5] but uptake of the intervention is low in many communities [6] and its efficacy is threatened by the emergence of high level resistance of P. falciparum to SP in some parts of Africa. There are currently no alternative drugs recommended for use in IPTp. The efficacy of intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine (IPTp-SP) in pregnancy is threatened in parts of Africa by the emergence and spread of resistance to SP. Intermittent screening with a rapid diagnostic test (RDT) and treatment of positive women (ISTp) is an alternative approach
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