A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy
Creators: name: Oduro, Abraham
name: Meshnick, Steven
name: Magnussen, Pascal
name: Tagbor, Harry
name: Kayentao, Kassoum
name: Doumbo, Ogobara
name: Bationo, Richard
name: Djimdé, Moussa
name: Quaye, Stephen
name: Hodgson, Abraham
name: Mohammed, Khalifa
name: Milligan, Paul
name: Awine, Timothy
name: Coulibaly, Sheick Oumar
name: Cairns, Matthew
name: Taylor, Steve
name: Soulama, Alamissa
name: Williams, John
name: Guirou, Etienne
name: Greenwood, Brian
name: Njie, Fanta
name: Ordi, Jaume
name: Dabira, Edgar
name: Woukeu, Arouna
name: Akor, Francis
name: ter Kuile, Feiko
name: Abubakar, Ismaela
name: Chandramohan, Daniel
name: Bojang, Kalifa
Publisher: name: The University of North Carolina at Chapel Hill University Libraries
Year: 2015

description: 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 NCT01084213Pan African Clinical trials Registry PACT201202000272122