NCT00374621
Completed
Not Applicable
Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate
ConditionsCervical Ripening
InterventionsMisoprostol with or without isosorbide mononitrate
Overview
- Phase
- Not Applicable
- Intervention
- Misoprostol with or without isosorbide mononitrate
- Conditions
- Cervical Ripening
- Sponsor
- Stanford University
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Time to vaginal delivery
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Yasser Yehia El-Sayed
Professor
Stanford University
Eligibility Criteria
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
Arms & Interventions
Misoprostol
Intervention: Misoprostol with or without isosorbide mononitrate
Misoprostol with Isosorbide Mononitrate
Intervention: Misoprostol with or without isosorbide mononitrate
Outcomes
Primary Outcomes
Time to vaginal delivery
Time Frame: First dose of study medication to delivery
Study Sites (1)
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