Abstract
BackgroundNew regimens for intermittent preventive treatment in pregnancy (IPTp) against malaria are needed as the effectiveness of the standard two-dose sulfadoxine-pyrimethamine (SP) regimen is under threat. Previous trials have shown that IPTp with monthly SP benefits HIV-positive primi- and secundigravidae, but there is no conclusive evidence of the possible benefits of this regimen to HIV-negative women, or to a population comprising of both HIV-positive and –negative women of different gravidities.MethodsThis study analyzed 484 samples collected at delivery as part of a randomized, partially placebo controlled clinical trial, conducted in rural Malawi between 2003 and 2007. The study included pregnant women regardless of their gravidity or HIV-infection status. The participants received SP twice (controls), monthly SP, or monthly SP and two doses of azithromycin (AZI-SP). The main outcome was the prevalence of peripheral Plasmodium falciparum malaria at delivery diagnosed with a real-time polymerase chain reaction (PCR) assay.FindingsOverall prevalence of PCR-diagnosed peripheral P. falciparum malaria at delivery was 10.5%. Compared with the controls, participants in the monthly SP group had a risk ratio (95% CI) of 0.33 (0.17 to 0.64, P<0.001) and those in the AZI-SP group 0.23 (0.11 to 0.48, P<0.001) for malaria at delivery. When only HIV-negative participants were analyzed, the corresponding figures were 0.26 (0.12 to 0.57, P<0.001) for women in the monthly SP group, and 0.24 (0.11 to 0.53, P<0.001) for those in the AZI-SP group.ConclusionsOur results suggest that increasing the frequency of SP administration during pregnancy improves the efficacy against malaria at delivery among HIV-negative women, as well as a population consisting of both HIV-positive and –negative pregnant women of all gravidities, in a setting of relatively low but holoendemic malaria transmission, frequent use of bed nets and high SP resistance.Trial RegistrationClinicalTrials.gov NCT00131235
Highlights
Malaria is one of the most important preventable causes of poor maternal health and adverse birth outcomes [1]
Our results suggest that increasing the frequency of SP administration during pregnancy improves the efficacy against malaria at delivery among human immunodeficiency virus (HIV)-negative women, as well as a population consisting of both HIV-positive and – negative pregnant women of all gravidities, in a setting of relatively low but holoendemic malaria transmission, frequent use of bed nets and high SP resistance
Participants and Received Treatment Of the 1320 Lungwena Antenatal Intervention Study (LAIS) participants [17], 484 (36.7%) had dried blood spots taken at delivery at a local health facility for the realtime polymerase chain reaction (PCR) assay targeting P. falciparum, and they formed the study population
Summary
Malaria is one of the most important preventable causes of poor maternal health and adverse birth outcomes [1]. In sub-Saharan Africa (SSA), an estimated 25 million pregnant women are in danger of Plasmodium falciparum infections every year [2]. The effectiveness of the standard two-dose SP IPTp is under threat due to increasing SP-resistance, declined malaria immunity among women infected with human immunodeficiency virus (HIV), possibly too long treatment interval, and difficulties in practical implementation [4,5,6,7,8,9,10,11,12,13]. Increasing the dosing frequency of SP has been considered as one possibility to improve the effectiveness of SP IPTp while alternative regimens are being explored. New regimens for intermittent preventive treatment in pregnancy (IPTp) against malaria are needed as the effectiveness of the standard two-dose sulfadoxine-pyrimethamine (SP) regimen is under threat. Previous trials have shown that IPTp with monthly SP benefits HIV-positive primi- and secundigravidae, but there is no conclusive evidence of the possible benefits of this regimen to HIV-negative women, or to a population comprising of both HIV-positive and –negative women of different gravidities
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