Status:
COMPLETED
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bill and Melinda Gates Foundation
Conditions:
Malaria
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Pregnant women will be scheduled to be seen in the clinic every 4 weeks during their pregnancy and then 1 and 6 weeks following delivery. In addition, pregnant women will be instructed to come to the ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2018
Estimated Enrollment :
782 Patients enrolled
Trial Details
Trial ID
NCT02793622
Start Date
September 1 2016
End Date
December 4 2018
Last Update
April 14 2021
Active Locations (1)
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1
IDRC - Tororo Research Clinic
Tororo, Uganda