Journal Article

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

Oumou M. Maiga, Kassoum Kayentao, Boubacar T. Traoré, Abdoulaye Djimde, Bouyagui Traoré, Mouctar Diallo, 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 and Ogobara K. Doumbo

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 53, issue 3, pages 215-223
Published in print August 2011 | ISSN: 1058-4838
Published online August 2011 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1093/cid/cir374
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

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(See the article by Harrington et al, on pages 224–230, and editorial commentary by Lake and Taylor, on pages 231–233.)

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.

Journal Article.  4997 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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