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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374621

Enrollment

156

Registered

2006-09-11

Start date

2006-09-30

Completion date

2010-01-31

Last updated

2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening

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.

Interventions

DRUGMisoprostol 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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to vaginal delivery	First dose of study medication to delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026