CompletedPhase 3

Prevention of Malaria in HIV-uninfected Pregnant Women and Infants

Uganda782 participantsStarted 2016-09

Plain-language summary

This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation will be randomized in equal proportions to one of two intermittent preventive treatment in pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant women will end approximately 6 weeks after giving birth. All children born to mothers enrolled in the study will be followed from birth until they reach 12 months of age.

Who can participate

Age range16 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by ultrasound * Estimated gestational age between 12-20 weeks * Confirmed to be HIV uninfected by rapid test * 16 years of age or older * Resident of Busia District, Uganda * Provision of informed consent by the pregnant woman for herself and her unborn child * Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol * Plan 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 * Chronic medical condition requiring frequent medical attention * Prior SP preventive therapy or any other antimalarial therapy during this pregnancy * Early or active labor (documented by cervical change with uterine contractions)

What they're measuring

Number of Participants Who Deliver With a Composite Adverse Birth Outcome

Timeframe: Delivery

Incidence of Malaria in Infants

Timeframe: Time at risk will begin at birth and end when study participants reaches 12 months of age or early study termination

Mean Gestational Age in Weeks at Birth

Timeframe: At the time of delivery

Trial details

NCT IDNCT02793622

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-04

Results submitted2020-11-17

View on ClinicalTrials.gov More Malaria trials