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

Stanford University156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Cervical Ripening

Interventions

Misoprostol with or without isosorbide mononitrateDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Time to vaginal delivery

Time frame: First dose of study medication to delivery

Data from ClinicalTrials.gov

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