Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate - Full Text View

Purpose

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	Intervention
Cervical Ripening.	Drug: Misoprostol with or without isosorbide mononitrate


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Isosorbide dinitrate Isosorbide Isosorbide mononitrate Misoprostol

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Time to vaginal delivery [ Time Frame: First dose of study medication to delivery ] [ Designated as safety issue: Yes ]


Enrollment:	156
Study Start Date:	September 2006
Study Completion Date:	January 2010
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374621

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Yasser Yehia El-Sayed	Stanford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Yasser Yehia El-Sayed, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00374621 History of Changes
Other Study ID Numbers:	97274
Study First Received:	September 7, 2006
Last Updated:	June 13, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Misoprostol Isosorbide Isosorbide-5-mononitrate Isosorbide Dinitrate 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

ClinicalTrials.gov processed this record on September 29, 2016