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 Traoré; Aissata Ongoiba; Didier Doumtabé; Safiatou Doumbo; Mamadou S. Traoré; Antoine Dara; Oumar Guindo; Diawara M. Karim; Siraman Coulibaly; Flabou Bougoudogo; Feiko Ter Kuile; Martin Danis; Ogobara K. Doumbo

doi: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

Oumou M. Maiga, Kassoum Kayentao, Boubacar T. Traoré, Abdoulaye Djimde, Bouyagui Traoré, Mouctar Traoré, Aissata Ongoiba, Didier Doumtabé, Safiatou Doumbo, Mamadou S. Traoré, Antoine Dara, Oumar Guindo, Diawara M. Karim, Siraman Coulibaly, Flabou Bougoudogo, Feiko Ter Kuile, Martin Danis, Ogobara K. Doumbo

Clinical Sciences

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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.

Original language	English
Pages (from-to)	215-223
Number of pages	9
Journal	Clinical Infectious Diseases
Volume	53
Issue number	3
DOIs	https://doi.org/10.1093/cid/cir374
Publication status	Published - 1 Mar 2011

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10.1093/cid/cir374

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Maiga, O. M., Kayentao, K., Traoré, B. T., Djimde, A., Traoré, B., Traoré, M., Ongoiba, A., Doumtabé, D., Doumbo, S., Traoré, M. S., Dara, A., Guindo, O., Karim, D. M., Coulibaly, S., Bougoudogo, F., Ter Kuile, F., Danis, M., & 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, 53(3), 215-223. https://doi.org/10.1093/cid/cir374

@article{e09df764c07e4b4294e93426c3250a56,

title = "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",

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.",

author = "Maiga, \{Oumou M.\} and Kassoum Kayentao and Traor{\'e}, \{Boubacar T.\} and Abdoulaye Djimde and Bouyagui Traor{\'e} and Mouctar Traor{\'e} and Aissata Ongoiba and Didier Doumtab{\'e} and Safiatou Doumbo and Traor{\'e}, \{Mamadou S.\} and Antoine Dara and Oumar Guindo and Karim, \{Diawara M.\} and Siraman Coulibaly and Flabou Bougoudogo and \{Ter Kuile\}, Feiko and Martin Danis and Doumbo, \{Ogobara K.\}",

year = "2011",

month = mar,

day = "1",

doi = "10.1093/cid/cir374",

language = "English",

volume = "53",

pages = "215--223",

journal = "Clinical Infectious Diseases",

issn = "1058-4838",

publisher = "Oxford University Press",

number = "3",

}

Maiga, OM, Kayentao, K, Traoré, BT, Djimde, A, Traoré, B, Traoré, M, Ongoiba, A, Doumtabé, D, Doumbo, S, Traoré, MS, Dara, A, Guindo, O, Karim, DM, Coulibaly, S, Bougoudogo, F, Ter Kuile, F, Danis, M & Doumbo, OK 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, no. 3, pp. 215-223. https://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. / Maiga, Oumou M.; Kayentao, Kassoum; Traoré, Boubacar T. et al.
In: Clinical Infectious Diseases, Vol. 53, No. 3, 01.03.2011, p. 215-223.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Maiga, Oumou M.

AU - Kayentao, Kassoum

AU - Traoré, Boubacar T.

AU - Djimde, Abdoulaye

AU - Traoré, Bouyagui

AU - Traoré, Mouctar

AU - Ongoiba, Aissata

AU - Doumtabé, Didier

AU - Doumbo, Safiatou

AU - Traoré, Mamadou S.

AU - Dara, Antoine

AU - Guindo, Oumar

AU - Karim, Diawara M.

AU - Coulibaly, Siraman

AU - Bougoudogo, Flabou

AU - Ter Kuile, Feiko

AU - Danis, Martin

AU - Doumbo, Ogobara K.

PY - 2011/3/1

Y1 - 2011/3/1

N2 - 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.

AB - 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.

U2 - 10.1093/cid/cir374

DO - 10.1093/cid/cir374

M3 - Article

SN - 1058-4838

VL - 53

SP - 215

EP - 223

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

IS - 3

ER -

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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