Status:
COMPLETED
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Cervical Ripening
Labor, Induced
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who ne...
Detailed Description
Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the wo...
Eligibility Criteria
Inclusion
- Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor
Exclusion
- No uterine scar (no previous delivery by cesarean section)
- No multiple gestation
- No condition that disallows use of prostaglandins for induction of labor
- No more than 3 previous vaginal births beyond 24 weeks gestation
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
1308 Patients enrolled
Trial Details
Trial ID
NCT00308711
Start Date
April 1 2006
End Date
August 1 2007
Last Update
June 25 2012
Active Locations (52)
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1
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35249
2
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
3
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
4
Arizona Wellness Center for Women
Phoenix, Arizona, United States, 85032