Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment in Pregnancy

This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) plus dihydroartemisinin-piperaquine (DP) significantly reduces the risk of malaria infection (primary outcome) and adverse birth outcomes (key secondary outcome) in an endemic area of Papua New Guinea (PNG), compared to IPTp with SP alone (the current standard of care). To test this hypothesis a double-blinded, placebo-controlled, phase-III, superiority trial will individually randomize 1,172 HIV-uninfected pregnant women enrolled from 12-26 gestational weeks in equal proportions to one of two IPTp arms: 1) SP given every for weeks, or 2) SP+DP given every 4 weeks. DP placebos will be used to ensure adequate blinding is achieved in the study and follow-up will end 28 days after giving birth.

NCT Number	NCT05426434
Lead Sponsor	Menzies School of Health Research Collaborators: Papua New Guinea Institute of Medical Research, University of Melbourne, Curtin University, Liverpool School of Tropical Medicine
Conditions	Malaria, Malaria in Pregnancy, Pregnancy Related
Enrollment	1,172 participants
Start Date	2022-08-31
Primary Completion	2025-03-31 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-06-06