Document Detail


Superiority of 3 over 2 doses of intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria during pregnancy in mali: a randomized controlled trial.
MedLine Citation:
PMID:  21765069     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: In 2003, Mali introduced intermittent preventive therapy in pregnancy (ITPp) with sulfadoxine-pyrimethamine (SP) for the control of malaria in pregnancy, consisting of 2 doses of SP given in the 2nd and 3rd trimester. This widely used regimen, although very effective, leaves many women unprotected from malaria during the last 4-to-8 weeks of gestation, which is a pivotal period for fetal weight gain. The aim of the study was to compare the efficacy and safety of 3-dose versus 2-dose IPTp-SP for the prevention of placental malaria and associated low birth weight (LBW).
METHODS: We conducted a parallel-group, open-label, individually randomized controlled superiority trial involving 814 women of all gravidity, enrolled from April 2006 through March 2008. All women were seen at least 3 times and received either 2 (n = 401) or 3 (n = 413) doses of IPTp-SP. The primary endpoint measured was placental malaria, LBW, preterm births, and maternal anemia were secondary endpoints, and severe maternal skin reactions and neonatal jaundice were safety endpoints.
RESULTS: Among the 96% of study subjects who were followed up until delivery, the prevalence of placental malaria was 2-fold lower in the 3-dose group (8.0%) than in the 2-dose group (16.7%); the adjusted prevalence ratio (APR) was 0.48 (95% confidence interval [CI], 0.32-0.71). LBW and preterm births were also reduced; the prevalence of LBW was 6.6% in the 3-dose group versus 13.3% in the 2-dose group (APR, 0.50; 95% CI, 0.32-0.79), and the prevalence of preterm births was 3.2% versus 8.9% (APR, 0.37; 95% CI, 0.19-0.71). No significant reductions in maternal anemia or differences in safety endpoints were observed.
CONCLUSIONS: Adding a third dose of ITPp-SP halved the risk of placental malaria, LBW, and preterm births in all gravidae, compared with the standard 2-dose regimen, in this area of highly seasonal transmission with low levels of SP resistance.
CLINICAL TRIALS REGISTRATION: ISRCTN 74189211.
Authors:
Oumou S Maïga Diakite; Oumou M Maiga; Kassoum Kayentao; Boubacar T Traoré; Abdoulaye Djimde; Bouyagui Traoré; Mouctar Diallo; Mouctar Traoré; Aissata Ongoiba; Didier Doumtabé; Safiatou Doumbo; Mamadou S Traoré; Antoine Dara; Oumar Guindo; Diawara M Karim; Siraman Coulibaly; Flabou Bougoudogo; Feiko O Ter Kuile; Martin Danis; Ogobara K Doumbo
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  53     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-07-18     Completed Date:  2011-11-08     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  215-23     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN74189211
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Anemia / prevention & control
Antimalarials / administration & dosage*,  adverse effects
Chemoprevention / adverse effects,  methods*
Drug Combinations
Female
Humans
Infant, Low Birth Weight
Infant, Newborn
Jaundice, Neonatal / prevention & control
Malaria / prevention & control*
Mali
Middle Aged
Pregnancy
Pregnancy Complications, Infectious / prevention & control*
Premature Birth / prevention & control
Pyrimethamine / administration & dosage*,  adverse effects
Skin Diseases / chemically induced
Sulfadoxine / administration & dosage*,  adverse effects
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Antimalarials; 0/Drug Combinations; 37338-39-9/fanasil, pyrimethamine drug combination; 88463U4SM5/Sulfadoxine; Z3614QOX8W/Pyrimethamine
Comments/Corrections
Comment In:
Clin Infect Dis. 2011 Aug 1;53(3):231-3   [PMID:  21765071 ]
Erratum In:
Clin Infect Dis. 2012 Feb 1;54(3):454
Note: Maiga, Oumou M [corrected to Diakite, Oumou S Maïga]; Traoré, Mouctar [corrected to Diallo, Mouctar]

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