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

Not Applicable

Completed

• Conditions: Cervical Ripening
• Interventions: Drug: Misoprostol with or without isosorbide mononitrate

• Registration Number: NCT00374621
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-11
• Primary Completion: 2007-12
• Study Completion: 2010-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Misoprostol with Isosorbide Mononitrate	Misoprostol with or without isosorbide mononitrate	-
Misoprostol	Misoprostol with or without isosorbide mononitrate	-

Primary Outcome Measures

Name	Time	Method
Time to vaginal delivery	First dose of study medication to delivery

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States