The purpose of this study is to determine the efficacy and safety of the addition of intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for cervical ripening and labor induction...
Date First Received: September 7, 2006
Last Updated: June 17, 2009
Verified by: Stanford University, June 2009
Clinical Trial Phase: N/A | Start Date: September 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 156
Brief Summary
Official Title: “Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to determine the efficacy and safety of the addition of intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for cervical ripening and labor induction.
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Single Group Assignment
Study Primary Completion Date: December 2007
Intervention(s) in this Clinical Trial
- Drug: isosorbide mononitrate
Outcome Measures for this Clinical Trial
Primary Measures
- Time to vaginal delivery
Criteria for Participation in this Clinical Trial
Inclusion Criteria::
- Pregnant women
- 18 years of age or greater
- Singleton pregnancy between 32-42 weeks gestation requiring labor induction
- Membranes must be intact
- Exclusion Criteria:- Ruptured membranes
- Gestational age less than 32 weeks
- Non-reassuring fetal heart rate tracing
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Stanford University
Overall Clinical Trial Officials and Contacts
Yasser Yehia El-Sayed Principal Investigator Stanford University
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00374621
Study ID Number: 97274
ClinicalTrials.gov Identifier: NCT00374621
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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