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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral misoprostol<br>oral misoprostol given 25 mcg every 2 hours | Drug: Misoprostol<br>* Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.<br>* Other names: Cytotec;|
| Active Comparator: Vaginal misoprostol<br>vaginal misoprostol given 25 mcg every 4 hours | Drug: Misoprostol<br>* Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Active Labor | Active phase of labor defined as greater than or equal to 6 cm cervical dilation | from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Initiation of Oxytocin for Labor Augmentation | The length of time (in hours) between the administration of misoprostol (first dose) and the first administration 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 | includes vaginal deliveries only; cesarean section deliveries are excluded | from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days | 
| Cesarean Section Rate | Number of cesarean sections/total deliveries (%) | From enrollment until delivery, up to 3 days | 
| Rate of Tachysystole | Tachysystole is defined as 4 or more contractions in a 10 minute period. | from enrollment until delivery, up to 3 days | 
| Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones | 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). | From enrollment until delivery, up to 3 days | 
| Rate of Need for Tocolysis | Tocolysis is the administration of medication to decrease or stop contractions. | from enrollment until delivery, up to 3 days | 
| Rate of Chorioamnionitis | Chorioamnionitis is defined as an intraamniotic infection. | from enrollment until delivery, up to 3 days | 
| Rate of Meconium Stained Fluid | Amniotic fluid with visible meconium (from fetal defecation) within it. | from enrollment until delivery, up to 3 days | 
| Neonatal Morbidity | 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. | 4 hours from delivery | 
| Rate of Anti-emetic Use | Use of medication to treat nausea. | from enrollment until delivery, up to 3 days | 
| Rate of Vaginal Delivery Within 24 Hours | Vaginal delivery within from start of induction with misoprostol. | 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 | 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 | from enrollment until delivery, up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol, cytotec, cervical ripening, labor, induced, active labor