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A non-inferiority, individually randomized trial of intermittent screening and treatment versus intermittent preventive treatment in the control of malaria in pregnancy

Publikation: Bidrag til tidsskriftTidsskriftartikel

  • 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
  • Feiko ter Kuile
  • Arouna Woukeu
  • Paul Milligan
  • Daniel Chandramohan
  • Brian Greenwood

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.

OriginalsprogEngelsk
Artikelnummere0132247
TidsskriftPloS one
Vol/bind10
Udgave nummer8
Antal sider17
ISSN1932-6203
DOI
StatusUdgivet - 2015

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