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

Penn State Health

Status and phase: Terminated; Phase 4

Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn; Pregnancy

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02777190

00005107

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Oral misoprostol

Experimental group

Description:

oral misoprostol given 25 mcg every 2 hours

Treatment:

Drug: Misoprostol

Vaginal misoprostol

Active Comparator group

Description:

vaginal misoprostol given 25 mcg every 4 hours

Treatment:

Drug: Misoprostol