A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

1. Pregnant Female Patients greater than or equal to 18 years of age

2. Induction of labor for a single live intrauterine pregnancy

3. Greater than or equal to 37 weeks gestational age

4. Cephalic presentation

5. 20 minute reassuring fetal heart rate (reactive nonstress test (NST))

6. Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.

7. Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

1. Previous uterine scar

2. Contraindication to vaginal delivery

3. Patients with preeclampsia

4. Grand multiparty - greater than or equal to 5 live births or stillbirths

5. Premature rupture of membranes

6. Suspected intrauterine growth restriction

7. Fetal anomalies

8. Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)