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

This study is ongoing, but not recruiting participants.

Sponsored by:	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

Drug Information available for: Isosorbide Isosorbide dinitrate Isosorbide-5-mononitrate Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate

Further study details as provided by Stanford University:

Primary Outcome Measures:

Time to vaginal delivery

Estimated Enrollment:

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

Study ID Numbers:	97274
Study First Received:	September 7, 2006
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00374621
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Nitric Oxide
Isosorbide
Isosorbide-5-mononitrate
Misoprostol
Isosorbide Dinitrate

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Oxytocics
Diuretics, Osmotic
Diuretics
Physiological Effects of Drugs
Gastrointestinal Agents
Cardiovascular Agents

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

ClinicalTrials.gov processed this record on January 16, 2009