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

Phase 4

Terminated

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

Interventions: Drug: Misoprostol

Registration Number: NCT02777190

Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 34

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral misoprostol	Misoprostol	oral misoprostol given 25 mcg every 2 hours
Vaginal misoprostol	Misoprostol	vaginal misoprostol given 25 mcg every 4 hours

Primary Outcome Measures

Name	Time	Method
Time to Active Labor	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 Outcome Measures

Name	Time	Method
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	The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation.
Time to Vaginal Delivery	from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days	includes vaginal deliveries only; cesarean section deliveries are excluded
Cesarean Section Rate	From enrollment until delivery, up to 3 days	Number of cesarean sections/total deliveries (%)
Rate of Tachysystole	from enrollment until delivery, up to 3 days	Tachysystole is defined as 4 or more contractions in a 10 minute period.
Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones	From enrollment until delivery, up to 3 days	Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant).
Rate of Need for Tocolysis	from enrollment until delivery, up to 3 days	Tocolysis is the administration of medication to decrease or stop contractions.
Rate of Chorioamnionitis	from enrollment until delivery, up to 3 days	Chorioamnionitis is defined as an intraamniotic infection.
Rate of Meconium Stained Fluid	from enrollment until delivery, up to 3 days	Amniotic fluid with visible meconium (from fetal defecation) within it.
Neonatal Morbidity	4 hours from delivery	binary composite outcome defined as Apgar score \< 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery.
Rate of Anti-emetic Use	from enrollment until delivery, up to 3 days	Use of medication to treat nausea.
Rate of Vaginal Delivery Within 24 Hours	24 hours from start of induction of labor (first misoprostol administration)	Vaginal delivery within from start of induction with misoprostol.
Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening	from enrollment until delivery, up to 3 days	Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead