drugset / Trial / NCT03297216
Improving Pregnancy Outcomes With Progesterone
Phase 3
Completed
800 enrolled
University of North Carolina, Chapel Hill
AMAG Pharmaceuticals, Inc. · collabBill and Melinda Gates Foundation · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
Timeline
- Start
- 2018-02-07
- Primary completion
- 2020-06-25
- Completion
- 2020-08-06
Publications
- Price JT, Vwalika B, Freeman BL, Cole SR, Saha PT, Mbewe FM, Phiri WM, Peterson M, Muyangwa D, Sindano N, Mwape H, Smithmyer ME, Kasaro MP, Rouse DJ, Goldenberg RL, Chomba E, Stringer JSA. Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial. Lancet HIV. 2021 Oct;8(10):e605-e613. doi: 10.1016/S2352-3018(21)00150-8. Epub 2021 Sep 9.
- Price JT, Vwalika B, Freeman BL, Cole SR, Mulenga HB, Winston J, Mbewe FM, Chomba E, Mofenson LM, Rouse DJ, Goldenberg RL, Stringer JSA. Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial. BMC Pregnancy Childbirth. 2019 Feb 27;19(1):81. doi: 10.1186/s12884-019-2224-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Progesterone | Other / unclassified | 250 mg | Intramuscular |