Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

• Status: Completed
• Trial end date: 2018-11-13
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Progesterone

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. viable intrauterine pregnancy confirmed by ultrasound

3. presentation to antenatal care prior to 24 weeks gestation

4. antibody-confirmed HIV-1 infection

5. initiating or continuing ART treatment in pregnancy

6. ability and willingness to provide written informed consent

7. willing to adhere to study visit schedule

Exclusion Criteria:

1. multiple gestation

2. non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)

3. planned or in situ cervical cerclage

4. evidence of threatened abortion, preterm labor, or ruptured membranes

5. major fetal anomaly detected on screening ultrasound

6. known uterine anomaly

7. known or suspected allergy or contraindication to VP or placebo components