Title:
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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
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Author:
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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 L.; 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
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Other authors:
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Universitat de Barcelona |
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. |
Subject(s):
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-Assaigs clínics de medicaments -Malària -Complicacions en l'embaràs -Medicina preventiva -Drug testing -Malaria -Complications of pregnancy -Preventive medicine |
Rights:
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cc by (c) Tagbor et al., 2015
http://creativecommons.org/licenses/by/3.0/es/ |
Document type:
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Article Article - Published version |
Published by:
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Public Library of Science (PLoS)
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