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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374621
First Posted: September 11, 2006
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
September 7, 2006
September 11, 2006
April 25, 2017
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00374621
97274
No
Not Provided
Not Provided
Yasser Yehia El-Sayed, Stanford University
Stanford University
Not Provided
Principal Investigator: Yasser Yehia El-Sayed Stanford University
Stanford University
April 2017

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