Status:
COMPLETED
Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
Lead Sponsor:
Grant Dorsey, M.D, Ph.D.
Collaborating Sponsors:
National Institutes of Health (NIH)
Infectious Diseases Research Collaboration, Uganda
Conditions:
Malaria
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Malaria in pregnancy remains a major challenge in Africa, where approximately 50 million women are at risk for P. falciparum infection during pregnancy each year. Among pregnant women living in malari...
Eligibility Criteria
Inclusion
- 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
- 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 chemopreventive therapy or any other antimalarial therapy during this pregnancy
- Early or active labor (documented by cervical change with uterine contractions)
- Multiple pregnancies (i.e. twins/triplets)
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2024
Estimated Enrollment :
2757 Patients enrolled
Trial Details
Trial ID
NCT04336189
Start Date
December 28 2020
End Date
July 28 2024
Last Update
November 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Infectious Diseases Research Collaboration Clinic - Masafu Hospital
Masafu, Busia, Uganda