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PREGNANT Short Cervix Trial

NCT00615550 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2012-03-13

Study results available
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Summary

The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.

Conditions

  • Preterm Delivery
  • Short Cervix
  • Short Uterine Cervical Length

Interventions

DRUG

progesterone

8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation

DRUG

placebo

vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Juniper Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • George W. Creasy, MD, FACOG · Columbia Laboratories, Inc.

  • Roberto Romero, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Sonia Hassan, MD · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Belarus
  • Chile
  • Czechia
  • India
  • Israel
  • Italy
  • Russia
  • South Africa
  • Ukraine

Study Locations

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Entities

Drugs

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 NCT00615550 on ClinicalTrials.gov