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

NCT ID: NCT00374621

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2010-01-31

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.

Conditions

Cervical Ripening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Misoprostol

Group Type: ACTIVE_COMPARATOR

Misoprostol with or without isosorbide mononitrate

Intervention Type: 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

Misoprostol with Isosorbide Mononitrate

Group Type: ACTIVE_COMPARATOR

Misoprostol with or without isosorbide mononitrate

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Yasser Yehia El-Sayed

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasser Yehia El-Sayed

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Collingham JP, Fuh KC, Caughey AB, Pullen KM, Lyell DJ, El-Sayed YY. Oral misoprostol and vaginal isosorbide mononitrate for labor induction: a randomized controlled trial. Obstet Gynecol. 2010 Jul;116(1):121-126. doi: 10.1097/AOG.0b013e3181e408f2.

Reference Type: DERIVED

PMID: 20567177 (View on PubMed)

Other Identifiers

97274

Identifier Type: -

Identifier Source: org_study_id