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

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy; Labor; Forced or Induced, Affecting Fetus or Newborn
• Intervention / Treatment: Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: misoprostol; cervical ripening; active labor; labor, induced; cytotec
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 00005107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No