Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda (NCT04336189) | Clinical Trial Compass
CompletedPhase 3
Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
Uganda2,757 participantsStarted 2020-12-28
Plain-language summary
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. This double-blinded randomized controlled phase III trial of 2757 HIV uninfected pregnant women enrolled at 12-20 weeks gestation will be randomized in equal proportions to one of three IPTp treatment arms: 1) SP given every 4 weeks, or 2) DP given every 4 weeks, or 3) SP+DP given every 4 weeks. SP or DP placebos will be used to ensure adequate blinding is achieved in the study and follow-up will end 28 days after giving birth.
Who can participate
Age range16 Years
SexFEMALE
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Inclusion criteria
✓. Viable singleton pregnancy confirmed by ultrasound
✓. Estimated gestational age between 12-20 weeks
✓. Confirmed to be HIV- uninfected by rapid test
✓. 16 years of age or older
✓. Residency within Busia District of Uganda
✓. Provision of informed consent
✓. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
✓. Willing to deliver in the hospital
Exclusion criteria
✕. History of serious adverse event to SP or DP
✕. Active medical problem requiring inpatient evaluation at the time of screening
✕. Intention of moving outside of Busia District Uganda
What they're measuring
1
Risk of Having a Composite Adverse Birth Outcome
Timeframe: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
2
Incidence of Serious Adverse Events (SAE) Per Time at Risk
Timeframe: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months
3
Incidence of Any Grade 3 or 4 or Serious Adverse Events Per Time at Risk
Timeframe: Time from first dose of study drugs up to 28 days postpartum, an average of 6 months