Trial of Cervical Ripening and Labor Induction Using 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Ripening

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol with or without isosorbide mononitrate

Drug

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

Primary outcomes

Time to vaginal delivery

Time frame: First dose of study medication to delivery

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2010
First posted: Sep 11, 2006
Registry last updated: Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed