Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
March 1, 2012 updated by: University of Florida
The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- Shands Hospital at the University of Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time to vaginal delivery
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Secondary Outcome Measures
Outcome Measure |
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Rate of chorioamnionitis
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Incidence of abnormal fetal heart rate tracings
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Rate of postpartum hemorrhage
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Incidence of NICU admissions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keri A Baacke, MD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
May 10, 2006
First Submitted That Met QC Criteria
May 10, 2006
First Posted (Estimate)
May 11, 2006
Study Record Updates
Last Update Posted (Estimate)
March 2, 2012
Last Update Submitted That Met QC Criteria
March 1, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 594-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.