Status:
COMPLETED
Improving Pregnancy Outcomes With Progesterone
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
AMAG Pharmaceuticals, Inc.
Conditions:
Pre-term Birth
HIV-1-infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
Detailed Description
Weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17P) or indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24 weeks gestation and ad...
Eligibility Criteria
Inclusion
- 18 years of age or older
- less than 24 0/7 weeks of gestation
- viable intrauterine singleton pregnancy confirmed by ultrasound
- antibody-confirmed HIV-1 infection
- currently receiving antiretroviral l therapy (ART) or intending to commence ART in pregnancy
- ability and willingness to provide written informed consent
- intent to remain in current geographical area of residence for the duration of study
- willing to adhere to weekly study visit schedule
Exclusion
- confirmed prior spontaneous preterm birth
- multiple gestation
- known uterine anomaly
- planned or in situ cervical cerclage
- major fetal anomaly detected on screening ultrasound
- indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)
- threatened abortion, preterm labor, or ruptured membranes at time of enrollment
- known allergy or medical comorbidity listed as a contraindication to 17P in the prescribing information
- prior participation in the trial
- any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2020
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03297216
Start Date
February 7 2018
End Date
August 6 2020
Last Update
July 22 2021
Active Locations (2)
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1
Kamwala District Clinic
Lusaka, Zambia
2
University Teaching Hospital
Lusaka, Zambia