- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777190
A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor
October 11, 2022 updated by: Jaimey M. Pauli, MD, Milton S. Hershey Medical Center
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral misoprostol
oral misoprostol given 25 mcg every 2 hours
|
Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
Other Names:
|
Active Comparator: Vaginal misoprostol
vaginal misoprostol given 25 mcg every 4 hours
|
Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: 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.
|
From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours
|
Time to Vaginal Delivery
Time Frame: 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
|
from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days
|
Cesarean Section Rate
Time Frame: From enrollment until delivery, up to 3 days
|
Number of cesarean sections/total deliveries (%)
|
From enrollment until delivery, up to 3 days
|
Rate of Tachysystole
Time Frame: from enrollment until delivery, up to 3 days
|
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
Time Frame: 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).
|
From enrollment until delivery, up to 3 days
|
Rate of Need for Tocolysis
Time Frame: from enrollment until delivery, up to 3 days
|
Tocolysis is the administration of medication to decrease or stop contractions.
|
from enrollment until delivery, up to 3 days
|
Rate of Chorioamnionitis
Time Frame: from enrollment until delivery, up to 3 days
|
Chorioamnionitis is defined as an intraamniotic infection.
|
from enrollment until delivery, up to 3 days
|
Rate of Meconium Stained Fluid
Time Frame: from enrollment until delivery, up to 3 days
|
Amniotic fluid with visible meconium (from fetal defecation) within it.
|
from enrollment until delivery, up to 3 days
|
Neonatal Morbidity
Time Frame: 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.
|
4 hours from delivery
|
Rate of Anti-emetic Use
Time Frame: from enrollment until delivery, up to 3 days
|
Use of medication to treat nausea.
|
from enrollment until delivery, up to 3 days
|
Rate of Vaginal Delivery Within 24 Hours
Time Frame: 24 hours from start of induction of labor (first misoprostol administration)
|
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
Time Frame: 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
|
from enrollment until delivery, up to 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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