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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

Maiga, O. M., Kayentao, Kassoum, Traore, B. T., Djimde, A., Traore, B., Diallo, M., Ongoiba, A., Doumtabe, D., Doumbo, S., Traore, M. S., Dara, A., Guindo, O., Karim, D. M., Coulibaly, S., Bougoudogo, F., terKuile, Feiko ORCID: https://orcid.org/0000-0003-3663-5617, Danis, M. and Doumbo, O. K. (2011) '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'. Clinical Infectious Diseases, Vol 53, Issue 3, pp. 215-223.

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Abstract

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.

Item Type: Article
Subjects: QV Pharmacology > QV 38 Drug action.
QW Microbiology and Immunology > QW 45 Microbial drug resistance. General or not elsewhere classified.
QX Parasitology > Protozoa > QX 135 Plasmodia
WA Public Health > Health Problems of Special Population Groups > WA 310 Maternal welfare
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 750 Malaria
WC Communicable Diseases > Tropical and Parasitic Diseases > WC 770 Therapy
WQ Obstetrics > Pregnancy Complications > WQ 256 Infectious diseases
Digital Object Identifer (DOI): https://doi.org/10.1093/cid/cir374
Depositing User: Martin Chapman
Date Deposited: 15 May 2014 09:03
Last Modified: 15 Jun 2018 14:48
URI: http://archive.lstmed.ac.uk/id/eprint/3708

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