Intermittent Preventive Treatment in Pregnancy With Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine to Prevent Malaria Infection and Reduce Adverse Pregnancy Outcomes in Papua New Guinea - a Randomised Controlled Trial

2021-4107

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.

2022-08-31

2025-02-01

2025-12-01

Recruiting

Early phase I

1172

Inclusion Criteria: * Pregnant women between 12-26 weeks' gestation * 16 years of age or older * Viable singleton intrauterine pregnancy * Permanent resident of the study area * Willing to adhere to scheduled and unscheduled study visit procedures * Willing to birth in a study clinic or hospital * Able to provide written informed consent Exclusion Criteria: * Multiple pregnancy (i.e. twins/triplets) * Known heart ailment or other chronic medical condition requiring frequent hospital care * Active medical problem requiring inpatient evaluation at the time of screening * Severe malformations or non-viable pregnancy if observed by ultrasound * Antimalarial therapy in the prior two weeks * Unable to provide written informed consent * Known allergy or contraindication to any of the study drugs * Early or active labour * Known HIV-positive status

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded randomized controlled trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Placebos will be used to mimic the identical dosing strategy such that every 4 weeks women will receive two drugs on day 1 (SP and placebo, or SP and DP) followed by one drug on days 2 and 3 (placebo or DP). One placebo that mimics the appearance of DP will be used. A randomization list will be computer generated by a member of the project who will not be directly involved in the conduct of the study. The randomization list will include consecutive treatment numbers with corresponding random treatment assignments. Randomized codes will correspond to the 2 treatment arms using permuted variable sized blocks.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1172, 'type': 'ESTIMATED'}}

2023-10-23