drugset / Trial / NCT02970552
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
Phase 4
Completed
140 enrolled
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.
Timeline
- Start
- 2017-07-01
- Primary completion
- 2018-11-13
- Completion
- 2018-11-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Progesterone | Other / unclassified | 200 mg | Other |
Indications
No indication recorded.