Phase 4 N=140 Randomized Triple-blind Prevention

Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

PreTerm Birth

Bottom Line

View on ClinicalTrials.gov: NCT02970552 ↗

Enrolled (actual)

140

Serious AEs

3.6%

Results posted

Feb 2020

Primary outcome: Primary: Adequate Adherence to Study Product — 62; 63 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vaginal Progesterone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Adequate Adherence to Study Product	62; 63	—
SECONDARY Acceptability of Use of Vaginal Progesterone (VP)	—	—
SECONDARY Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study	7; 1; 0; 0; 19; 11	—
SECONDARY Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs)	15; 6; 9; 3; 19; 10	—
SECONDARY Acceptability of a Vaginal Medication to Prevent Preterm Birth	0; 0; 0; 0; 0; 1	—
SECONDARY Reported Barriers to Adherence to Study Product	0; 2; 0; 0; 0; 0	—
SECONDARY Sensitivity, Specificity, and Predictive Value of Dose Diaries	0.999; 0.571; 0.985; 0.975	—
SECONDARY Enrollment of Eligible Participants	154; 140	—
SECONDARY Ascertainment of Date of Delivery and Infant Vital Status	67; 67	—
SECONDARY Preliminary Efficacy	9; 10; 8; 10; 5; 6	—
SECONDARY Birth Weight	9; 12	—
SECONDARY Stillbirth	2; 2	—
SECONDARY Adverse Events	1; 0; 2; 2	—

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.

Eligibility Criteria

Inclusion Criteria

18 years of age or older
viable intrauterine pregnancy confirmed by ultrasound
presentation to antenatal care prior to 24 weeks gestation
antibody-confirmed HIV-1 infection
initiating or continuing ART treatment in pregnancy
ability and willingness to provide written informed consent
willing to adhere to study visit schedule

Exclusion Criteria

multiple gestation
non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
planned or in situ cervical cerclage
evidence of threatened abortion, preterm labor, or ruptured membranes
major fetal anomaly detected on screening ultrasound
known uterine anomaly
known or suspected allergy or contraindication to VP or placebo components

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02970552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.