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 range

16 Years

Sex

FEMALE

See this in plain English?

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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