CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 140 enrolled
Drug / intervention
Vaginal Progesterone +1 moredrug
Likely dose
Vaginal Progesterone 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02970552
NCT02970552Phase 4Completed
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A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy

University of North Carolina, Chapel Hill·interventional·Posted Nov 22, 2016·Updated Feb 6, 2020

In Brief

A Phase 4 clinical trial evaluating Vaginal Progesterone and Placebo for PreTerm Birth. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreTerm Birth
CountriesZambia
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 22, 2016
Enrollment StartJul 1, 2017
Primary CompletionNov 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.6 years ago

Interventions

Vaginal Progesteronedrug

200 mg micronized vaginal progesterone suppository

Placebodrug

Indistinguishable placebo vaginal suppository