Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester
Phase 4
Completed
- Conditions
- Pregnancy Trimester, SecondInduced Abortion
- Interventions
- Device: Foley bulb
- Registration Number
- NCT00324519
- Lead Sponsor
- University of Florida
- Brief Summary
The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.
- Detailed Description
Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
- indication for pregnancy termination, gestational age from 13-27 weeks
Exclusion Criteria
- multiple gestation, previous uterine surgery, rupture of membranes, latex allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol Drug misoprostol This is the misoprostol drug. The Foley Bulb Foley bulb This is the experimental portion to test the Foley Bulb.
- Primary Outcome Measures
Name Time Method Time to vaginal delivery
- Secondary Outcome Measures
Name Time Method Rate of chorioamnionitis Rate of maternal fever Rate of postpartum hemorrhage
Trial Locations
- Locations (1)
Shands Hospital at the University of Florida
🇺🇸Gainesville, Florida, United States