Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/69255
Title: A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy
Author: 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
Woukeu, Arouna
Milligan, Paul
Chandramohan, Daniel
Greenwood, Brian
Keywords: Assaigs clínics de medicaments
Malària
Complicacions en l'embaràs
Medicina preventiva
Drug testing
Malaria
Complications of pregnancy
Preventive medicine
Issue Date: 10-Aug-2015
Publisher: Public Library of Science (PLoS)
Abstract: 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.
Note: Reproducció del document publicat a: http://dx.doi.org/10.1371/journal.pone.0132247
It is part of: PLoS One, 2015, vol. 10, num. 8, p. e0132247
Related resource: http://dx.doi.org/10.1371/journal.pone.0132247
URI: http://hdl.handle.net/2445/69255
ISSN: 1932-6203
Appears in Collections:Articles publicats en revistes (Fonaments Clínics)
Articles publicats en revistes (ISGlobal)

Files in This Item:
File Description SizeFormat 
658865.pdf1.36 MBAdobe PDFView/Open


This item is licensed under a Creative Commons License Creative Commons