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

This study is ongoing, but not recruiting participants.

First Received: September 7, 2006 Last Updated: December 10, 2009 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00374621

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: isosorbide mononitrate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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-5-mononitrate Misoprostol Isosorbide dinitrate Isosorbide

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 ]

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

Eligibility

Ages Eligible for Study:	18 Years and older
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

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

No publications provided

Responsible Party:	Stanford University School of Medicine ( Yasser Yehia El-Sayed )
Study ID Numbers:	97274
Study First Received:	September 7, 2006
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00374621 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Isosorbide
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Oxytocics
Isosorbide-5-mononitrate
Diuretics, Osmotic
Misoprostol
Diuretics
Physiological Effects of Drugs
Gastrointestinal Agents

Isosorbide Dinitrate
Reproductive Control Agents
Cardiovascular Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions
Nitric Oxide Donors
Natriuretic Agents
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents

ClinicalTrials.gov processed this record on February 08, 2010