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

Cervical Ripening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374621
• Other study ID #: 97274
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: April 24, 2017
• Start date: September 2006
• Est. completion date: January 2010

Study information

• Verified date: April 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 2010
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to vaginal delivery		First dose of study medication to delivery