MedTrace Logo

Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

NCT02913495 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-02-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Premature Birth

Interventions

DRUG

Vaginal Progesterone

DRUG

Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)

Sponsors & Collaborators

  • Baystate Medical Center

    collaborator OTHER

  • George Washington University

    collaborator OTHER

  • Vriginia Commonwealth University

    collaborator UNKNOWN

  • Ohio State University

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Rupsa C Boelig, MD · Thomas Jefferson University Hospital; Sidney Kimmel Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-08-31
Completion
2021-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02913495 on ClinicalTrials.gov