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

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ClinicalTrials.gov Identifier: NCT00374621
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Ripening Drug: Misoprostol with or without isosorbide mononitrate Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate
Study Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Misoprostol 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 with Isosorbide Mononitrate 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


Outcome Measures
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Primary Outcome Measures :
  1. Time to vaginal delivery [ Time Frame: First dose of study medication to delivery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374621


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Yasser Yehia El-Sayed Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yasser Yehia El-Sayed, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00374621    
Other Study ID Numbers: 97274
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
 Gastrointestinal Agents
Oxytocics
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action