A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Overview
- Phase
- Phase 4
- Intervention
- Misoprostol
- Conditions
- Labor; Forced or Induced, Affecting Fetus or Newborn
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Time to Active Labor
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Jaimey M. Pauli, MD
Principal Investigator
Milton S. Hershey Medical Center
Eligibility Criteria
Inclusion Criteria
- •Pregnant Female Patients greater than or equal to 18 years of age
- •Induction of labor for a single live intrauterine pregnancy
- •Greater than or equal to 37 weeks gestational age
- •Cephalic presentation
- •20 minute reassuring fetal heart rate (reactive nonstress test (NST))
- •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.
- •Equal to 3 or less uterine contractions over 10 minutes
Exclusion Criteria
- •Previous uterine scar
- •Contraindication to vaginal delivery
- •Patients with preeclampsia
- •Grand multiparty - greater than or equal to 5 live births or stillbirths
- •Premature rupture of membranes
- •Suspected intrauterine growth restriction
- •Fetal anomalies
- •Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
Arms & Interventions
Oral misoprostol
oral misoprostol given 25 mcg every 2 hours
Intervention: Misoprostol
Vaginal misoprostol
vaginal misoprostol given 25 mcg every 4 hours
Intervention: Misoprostol
Outcomes
Primary Outcomes
Time to Active Labor
Time Frame: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
Active phase of labor defined as greater than or equal to 6 cm cervical dilation
Secondary Outcomes
- Time to Initiation of Oxytocin for Labor Augmentation(From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours)
- Time to Vaginal Delivery(from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days)
- Cesarean Section Rate(From enrollment until delivery, up to 3 days)
- Rate of Tachysystole(from enrollment until delivery, up to 3 days)
- Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones(From enrollment until delivery, up to 3 days)
- Rate of Need for Tocolysis(from enrollment until delivery, up to 3 days)
- Rate of Chorioamnionitis(from enrollment until delivery, up to 3 days)
- Rate of Meconium Stained Fluid(from enrollment until delivery, up to 3 days)
- Neonatal Morbidity(4 hours from delivery)
- Rate of Anti-emetic Use(from enrollment until delivery, up to 3 days)
- Rate of Vaginal Delivery Within 24 Hours(24 hours from start of induction of labor (first misoprostol administration))
- Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening(from enrollment until delivery, up to 3 days)