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

NCT02777190 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 00005107
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

misoprostol; cytotec; cervical ripening; labor, induced; active labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

Study Arms (2)

Oral misoprostol

EXPERIMENTAL

oral misoprostol given 25 mcg every 2 hours

Drug: Misoprostol

Vaginal misoprostol

ACTIVE COMPARATOR

vaginal misoprostol given 25 mcg every 4 hours

Drug: Misoprostol

Interventions

Misoprostol DRUG

Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.

Also known as: Cytotec

Oral misoprostol; Vaginal misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• 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.

  PMID: 34155622 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Limitations include that during the COVID-19 pandemic, all in person research was suspended. Research time was reallocated to clinical time for providers. Recruitment was difficult. We had multiple changes in the research team requiring retraining. Ultimately, we were not able to recruit the numbers needed so the trial was terminated with inadequate numbers of subjects analyzed. Multiple turnovers led to a delay in completing our close out.

Results Point of Contact

• Title: Dr. Jaimey Pauli
• Organization: Penn State Milton S. Hershey Medical Center

jpauli@pennstatehealth.psu.edu

717-531-8142

Study Officials

• Jaimey Pauli, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: November 1, 2017
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: October 13, 2022
• Results First Posted: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)