Back to resultsRandomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
Primary Purpose
Premature Birth, Cervical Ripening
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Misoprostol
Foley bulb
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth focused on measuring Preterm gestation, Cervical ripening, Labor induction, Misoprostol, Foley bulb
Eligibility Criteria
Inclusion Criteria: singleton gestation, gestational age 23-35 weeks, indication for induction Exclusion Criteria: multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death
Sites / Locations
- Shands Hospital at the University of Florida
Outcomes
Primary Outcome Measures
Time to vaginal delivery
Secondary Outcome Measures
Rate of chorioamnionitis
Incidence of abnormal fetal heart rate tracings
Rate of postpartum hemorrhage
Incidence of NICU admissions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00325026
Brief Title
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
Official Title
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.
Detailed Description
Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Cervical Ripening
Keywords
Preterm gestation, Cervical ripening, Labor induction, Misoprostol, Foley bulb
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Type
Device
Intervention Name(s)
Foley bulb
Primary Outcome Measure Information:
Title
Time to vaginal delivery
Secondary Outcome Measure Information:
Title
Rate of chorioamnionitis
Title
Incidence of abnormal fetal heart rate tracings
Title
Rate of postpartum hemorrhage
Title
Incidence of NICU admissions
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
singleton gestation, gestational age 23-35 weeks, indication for induction
Exclusion Criteria:
multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keri a Baacke, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
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