DPSP Study: Optimal chemopreventive regimens to prevent malaria and improve birth outcomes in Uganda (Optimizing IPTp in Uganda).
Study period:Ongoing.
The “Optimizing IPTp in Uganda” study (DPSP study) is a double-blind randomized controlled trial seeking to assess the benefits of combining sulfadoxine-pyrimethamine (SP) and dihydroartemisinin-piperaquine (DP) for intermittent preventive treatment of malaria in pregnancy (IPTp).
Malaria in pregnancy is a major public health problem in sub-Saharan Africa, where it has been associated with adverse birth outcomes, including spontaneous abortions, preterm births, low birth weight, stillbirths, and neonatal deaths. The World Health Organization recommends IPTp with SP, a broad-spectrum antibiotic as well as an antimalarial, as one of the main interventions to improve birth outcomes. However, the effectiveness of SP for IPTp is compromised by widespread resistance of malaria parasites to SP. Studies evaluating alternative drugs for IPTp have shown DP to be a promising alternative.
Compared to IPTp-SP, IPTp-DP has been shown to significantly reduce the risk of malaria parasitemia during pregnancy and placental malaria at delivery. However, IPTp-DP has not been shown to significantly reduce the risk of adverse birth outcomes compared to IPTp-SP. This could possibly be due to additional protective effects of SP on non-malaria causes of adverse birth outcomes.
We hypothesize that IPTp with a combination of SP+DP will improve birth outcomes compared to IPTp with either SP or DP alone. To test this hypothesis, we are conducting a double-blind, randomized trial in 2757 HIV-negative pregnant women residing in Busia, Uganda, who will be randomized to receive one of the three IPTp arms: 1) monthly IPTp with SP, 2) monthly IPTp with DP, and 3) monthly IPTp with SP + DP. Enrolled pregnant women will be followed through delivery.
Specifically, the study seeks to:
- Compare the risk of adverse birth outcomes (spontaneous abortion, preterm births, low birth weight, small for gestation age, stillbirth, and neonatal death) among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP.;
- Compare safety and tolerability of IPTp regimens among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP.;
- Compare risks of malaria-specific (clinical malaria, placental malaria) and non-malarial outcomes (reproductive tract infections) among pregnant women randomized to receive monthly IPTp with SP vs. DP vs. SP+DP.
Study site: Masafu General Hospital, Busia
Collaborators:
Principal Investigators: Moses Kamya,Grant Dorsey and Philip Rosenthal
Project Manager: Dr Abel Kakuru
Project Coordinator: Dr Jimmy Kizza
The study is conducted by: collaborators from Makerere University College of Health Sciences, University of California San Francisco, Stanford University, and the Infectious Diseases Research collaboration.
The study will be conducted from 2020-2024.
