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Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

NCT00946088 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-03-16

Study results available
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Summary

Preterm delivery is the most common cause of infant morbidity and mortality in the United States. Some women have episodes of preterm labor during their pregnancy which can be temporarily stopped. These women, however, are at high risk for delivering before term. At this time, we do not have sufficient evidence to use any medication to help prevent these women from delivering early. Recently, preliminary studies have shown that progesterone may help prevent some women at high risk for preterm delivery from delivering early. Our study will investigate whether progesterone can help this specific group of women, women with arrested preterm labor, deliver healthy infants at term.

Conditions

  • Pregnancy Complications

Interventions

DRUG

Progesterone

Progesterone 400 mg per vagina qhs.

DRUG

Polyethylene glycol&hydrogenated vegetable oil.

Placebo Comparator: Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina qhs.

Sponsors & Collaborators

Principal Investigators

  • Deirdre Judith Lyell, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-02-28
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00946088 on ClinicalTrials.gov