A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy

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Tagbor, Harry ; Cairns, Matthew ; Bojang, Kalifa ; Coulibaly, Sheikh ; Kayentao, Kassoum ; Williams, John ; Abubakar, Ismaela ; Akor, Francis ; Mohammed, Khalifa ; Bationo, Richard ; Dabira, Edgar ; Soulama, Alamissa ; Djimdé, Moussa ; Guirou, Etienne ; Awine, Timothy ; Quaye, Stephen ; Njie, Fanta ; Ordi i Majà, Jaume ; Doumbo, Ogobara ; Hodgson, Abraham ; Oduro, Abraham ; Meshnick, Steven ; Taylor, Steve ; Magnussen, Pascal ; Ter Kuile, Feiko O. ; Woukeu, Arouna ; Milligan, Paul ; Chandramohan, Daniel ; Greenwood, Brian (2015)
  • Publisher: Public Library of Science (PLoS)
  • Journal: volume 10, issue 8 (eissn: 1932-6203)
  • Related identifiers: doi: 10.1371/journal.pone.0132247, pmc: PMC4530893
  • Subject: Drug testing | Research Article | Malària | Preventive medicine | wa_110 | Complicacions en l'embaràs | wc_765 | Malaria | wa_310 | wc_750 | Assaigs clínics de medicaments | wq_200 | Complications of pregnancy | Medicina preventiva
    mesheuropmc: parasitic diseases

BACKGROUND: 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. METHODS AND FINDINGS: An 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. CONCLUSIONS: Despite 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 REGISTRATION: ClinicalTrials.gov NCT01084213 Pan African Clinical trials Registry PACT201202000272122.
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