A Randomized, Control Trial for Preinduction Cervical Ripening
The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods...
Brief Summary
Official Title: “A Randomized, Control Trial for Preinduction Cervical Ripening”
The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
- Study Primary Completion Date: August 2007
Intervention(s) in this Clinical Trial
- Drug: Misoprostol
- Drug: oxytocin
Outcome Measures for this Clinical Trial
Primary Measures
- Vaginal Delivery rates
Secondary Measures
- Time interval to delivery
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Women that are hospitalized for induction of labor that have a Bishop's score <5
- singleton gestation
- cephalic presentation
- 24 weeks gestational age
Exclusion Criteria:
- Prior uterine surgery
- malpresentation
- placenta previa or abruption
- clinically suspected or diagnosed intra amniotic infection
- genital HSV infection
- multiple gestation
- premature rupture of the membranes
- active labor
- maternal/fetal conditions that may preclude labor induction in the opinion of the investigators
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: The University of Texas Health Science Center, Houston Other
Overall Clinical Trial Officials and Contacts
Michael Lucas, MD Principal Investigator The University of Texas Health Science Center, Houston
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00393731
Study ID Number: HSC-MS-04-008
ClinicalTrials.gov Identifier: NCT00393731
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00393731
