Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
Status:
Completed
Trial end date:
2018-11-13
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)