NCT01812239

Vaginal Progesterone in Twins With Short Cervix

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Obstetrix Medical Group · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age. Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs. placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.

Conditions

• Premature Birth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-08-01
• Completion: 2018-08-01
• First posted: 2013-03-18
• Last updated: 2014-12-19

Locations

1 site across 1 country: United States