At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 465 enrolled
Drug / intervention
progesterone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)]
In Brief
A Phase 3 clinical trial evaluating progesterone and placebo for Preterm Delivery and 2 related conditions. Completed, enrolled 465 participants across 49 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelarus, Chile, Czechia, India, Israel, Italy, Russia, South Africa, Ukraine, United States
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartMar 2008
Primary CompletionNov 2010
TodayJul 2026
First PostedFeb 14, 2008
Enrollment StartMar 1, 2008
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.4 years ago
Interventions
progesteronedrug
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
placebodrug
vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation