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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00374621
First received: September 7, 2006
Last updated: June 13, 2011
Last verified: June 2011

September 7, 2006
June 13, 2011
September 2006
December 2007   (final data collection date for primary outcome measure)
Time to vaginal delivery [ Time Frame: First dose of study medication to delivery ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00374621 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Ripening.
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
  • Active Comparator: Misoprostol
    Intervention: Drug: Misoprostol with or without isosorbide mononitrate
  • Active Comparator: Misoprostol with Isosorbide Mononitrate
    Intervention: Drug: Misoprostol with or without isosorbide mononitrate
Collingham JP, Fuh KC, Caughey AB, Pullen KM, Lyell DJ, El-Sayed YY. Oral misoprostol and vaginal isosorbide mononitrate for labor induction: a randomized controlled trial. Obstet Gynecol. 2010 Jul;116(1):121-6. doi: 10.1097/AOG.0b013e3181e408f2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
January 2010
December 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374621
97274
No
Yasser Yehia El-Sayed, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP