Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate

Verified by: Stanford University, June 2011
First Received: September 7, 2006 | Last Updated: June 13, 2011 | Phase: N/A | Start Date: September 2006
Overall Status: Completed | Estimated Enrollment: 156
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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...

Brief Summary

Official Title: “Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

  • Drug: Misoprostol with or without isosorbide mononitrate
    • Misoprostol 50 micrograms orally then 100 micrograms every 4 hours for up to four doses until modified Bishop score of 8 or higher was observed vs. the same misoprostol dosing plus isosorbide mononitrate 40 mg vaginally every 6 hours up to two doses total until a modified Bishop sore of at least 8 was observed

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Misoprostol
  • Active Comparator: Misoprostol with Isosorbide Mononitrate

Outcome Measures for this Clinical Trial

Primary Measures

  • Time to vaginal delivery
    • Time Frame: First dose of study medication to delivery
      Safety Issue?: Yes

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 Investigator Information

Lead Investigator: Stanford University Other

Overall Clinical Trial Officials and Contacts

Yasser Yehia El-Sayed Principal Investigator Stanford University  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00374621