Impact of Intermittent Preventive Treatment for Malaria in Pregnancy With Sulfadoxine-Pyrimethamine, Dihydroartemisinin-Piperaquine, and Their Combination on Infant Outcomes: A Randomized Controlled Trial

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BACKGROUND: Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine (IPTp-DP) is more effective than sulfadoxine-pyrimethamine (IPTp-SP) at reducing the burden of malaria in pregnancy in settings with high SP resistance. Paradoxically, IPTp-DP has been associated with lower birth weights compared with IPTp-SP. Whether the impacts of IPTp-DP extend after birth is unknown. METHODS: We conducted a double-blind randomized controlled trial to compare malaria burden and growth among infants born to mothers who were randomized to monthly IPTp-SP, IPTp-DP, or IPTp-DP+SP. Infants were followed to 12 months of age by passive and active surveillance. The primary outcome was clinical malaria incidence; secondary outcomes included parasite prevalence by microscopy or quantitative PCR, and infant growth outcomes. RESULTS: Among 871 infants enrolled, there were 667 episodes of clinical malaria. Compared to infants whose mothers received IPTp-SP, malaria incidence was similar in infants whose mothers received IPTp-DP (incidence rate ratio [IRR] 1.04, 95% confidence interval (CI) 0.78-1.38) or IPTp-DP+SP (IRR=0.93, 95% CI 0.68-1.26). Overall parasite prevalence at monthly visits was 21.8%. Parasite prevalence was also similar between groups. The prevalence of wasting at birth was higher in infants whose mothers received IPTp-DP+SP (PR= 2.30, 95% CI 1.07, 4.97) or IPTp-DP (RR= 2.25, 95% CI 1.03, 4.94) than those that received IPTp-SP, but differences between groups resolved by 3-6 months of age. CONCLUSION: There were no significant differences in infant outcomes between the three IPTp arms apart from a transiently increased risk of wasting among infants born to mothers who received DP-containing IPTp regimens.

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