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Vaginal Progesterone in Twins With Short Cervix

NCT01812239 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2014-12-19

No results posted yet for this study

Summary

A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.

Conditions

  • Premature Birth

Interventions

DRUG

Vaginal Progesterone gel.

Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.

PROCEDURE

fetal fibronectin swab.

Collection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms. Randomziation occurs between 20 weeks - 24 weeks of gestation.

DRUG

Placebo gel

weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.

Sponsors & Collaborators

  • Obstetrix Medical Group

    lead INDUSTRY

Principal Investigators

  • Andrew Combs, MD · Pediatrix

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-08-31
Completion
2018-08-31

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 NCT01812239 on ClinicalTrials.gov