NCT00615550

PREGNANT Short Cervix Trial

The Effect of Vaginal Progesterone Administration in the Prevention of Preterm Birth in Women With a Short Cervix [Vaginal Progesterone Bioadhesive Gel (Prochieve)® Extending Gestation A New Therapy for Short Cervix - Trial (PREGNANT Short Cervix - Trial)]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Juniper Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

A Short uterine cervical length in the mid-trimester is the most powerful predictor of preterm birth.

Conditions

• Preterm Delivery
• Short Cervix
• Short Uterine Cervical Length

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-02-14
• Last updated: 2012-03-13
• Results posted: 2012-03-13

Locations

49 sites across 10 countries: United States, Belarus, Chile, Czechia, India, Israel, Italy, Russia, South Africa, Ukraine