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Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor

NCT01840228 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-06-18

Study results available
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Summary

Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. However, current use of this therapy is limited to certain high-risk groups including women with a history of preterm birth and women with a short cervix. This study seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women with arrested preterm labor. The investigators hypothesize that administration of vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours after cessation of short-term therapy to inhibit contractions will result in lower rates of preterm birth before 37 weeks' than will administration of placebo.

Conditions

  • Premature Birth
  • Obstetric Labor, Premature

Interventions

DRUG

Micronized progesterone suppository

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • George A Macones, MD, MSCE · Washington University School of Medicine

  • Heather A Frey, MD, MSCI · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-05-07
Completion
2018-05-07

Countries

  • United States

Study Locations

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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 NCT01840228 on ClinicalTrials.gov