PLoS ONE (Jan 2015)

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

  • Harry Tagbor,
  • Matthew Cairns,
  • Kalifa Bojang,
  • Sheick Oumar Coulibaly,
  • Kassoum Kayentao,
  • John Williams,
  • Ismaela Abubakar,
  • Francis Akor,
  • Khalifa Mohammed,
  • Richard Bationo,
  • Edgar Dabira,
  • Alamissa Soulama,
  • Moussa Djimdé,
  • Etienne Guirou,
  • Timothy Awine,
  • Stephen Quaye,
  • Fanta Njie,
  • Jaume Ordi,
  • Ogobara Doumbo,
  • Abraham Hodgson,
  • Abraham Oduro,
  • Steven Meshnick,
  • Steve Taylor,
  • Pascal Magnussen,
  • Feiko ter Kuile,
  • Arouna Woukeu,
  • Paul Milligan,
  • Daniel Chandramohan,
  • Brian Greenwood

DOI
https://doi.org/10.1371/journal.pone.0132247
Journal volume & issue
Vol. 10, no. 8
p. e0132247

Abstract

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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.