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

Stanford University

Status: Completed

Conditions: Cervical Ripening

Treatments: Drug: Misoprostol with or without isosorbide mononitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00374621

97274

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Misoprostol

Active Comparator group

Treatment:

Drug: Misoprostol with or without isosorbide mononitrate

Misoprostol with Isosorbide Mononitrate

Active Comparator group

Treatment:

Drug: Misoprostol with or without isosorbide mononitrate