CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 210 enrolled
Drug / intervention
Vaginal Progesterone +1 moredrug
Likely dose
Not stated in 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/NCT02913495
NCT02913495Phase 4Completed
CompareCT.gov

Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

Thomas Jefferson University·interventional·Posted Sep 23, 2016·Updated Feb 24, 2026

In Brief

A Phase 4 clinical trial evaluating Vaginal Progesterone and Intramuscular Progesterone (17 alpha hydroxprogesterone caproate) for Premature Birth. Completed, enrolled 210 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Birth
CountriesUnited States
CollaboratorsBaystate Medical Center, George Washington University, Vriginia Commonwealth University, Ohio State University

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 23, 2016
Enrollment StartSep 1, 2016
Primary CompletionAug 1, 2021
Study CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.8 years ago

Interventions

Vaginal Progesteronedrug

Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)drug