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.
In: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jg. 53 (2011-08-01), Heft 3, S. 215-23
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Zugriff:
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.
| Titel: |
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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| Autor/in / Beteiligte Person: | Diakite, OS ; Kayentao, K ; Traoré, BT ; Djimde, A ; Traoré, B ; Diallo, M ; Ongoiba, A ; Doumtabé, D ; Doumbo, S ; Traoré, MS ; Dara, A ; Guindo, O ; Karim, DM ; Coulibaly, S ; Bougoudogo, F ; Ter Kuile, FO ; Danis, M ; Doumbo, OK |
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| Zeitschrift: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jg. 53 (2011-08-01), Heft 3, S. 215-23 |
| Veröffentlichung: | Jan. 2011- : Oxford : Oxford University Press ; <i>Original Publication</i>: Chicago, IL : The University of Chicago Press, c1992-, 2011 |
| Medientyp: | academicJournal |
| ISSN: | 1537-6591 (electronic) |
| DOI: | 10.1093/cid/cir374 |
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