At a glance
ClinicalIndex Comparison RecordN/ACompleted· 376 enrolled
Drug / intervention
CERVIDIL (Dinoprostone) +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.
A Randomized Controlled Trial of Transcervical Foley Balloon Compared to Controlled Release Prostaglandin (Cervidil) for Labor Induction and Cervical Ripening in Term and Near Term Women
In Brief
A clinical study evaluating CERVIDIL (Dinoprostone) and FOLEY BALLOON for Labor Induction. Completed, enrolled 376 participants across 2 sites.
Detailed Summary
OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction. HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabor Induction
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJul 2011
Primary CompletionNov 2014
Study CompletionFeb 2015
TodayJul 2026
First PostedJul 26, 2011
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.9 years ago
Interventions
CERVIDIL (Dinoprostone)drug
INDUCTION OF LABOR
FOLEY BALLOONdevice
INDUCTION OF LABOR