Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor

NCT01519765 | Terminated Phase 4 Results DMC

• 1 other identifier: UCLA IRB#11-002056
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue, is a widely accepted induction agent, that has been proven safe and effective for induction of labor. It stimulates both cervical ripening and uterine contractions, thus making it an ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of different administration routes and effects on uterine contractility, side effects, and safety. Vaginal misoprostol has been shown to be superior over oral administration however patients often prefer a more tolerable route. Buccal administration has already been shown to be as effective as vaginal misoprostol for cervical ripening and induction in both first trimester and second trimester abortions. There is minimal research comparing buccal versus vaginal for third trimester induction of labor. The investigators study is a prospective, double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Vaginal Delivery Within 24 Hours of Labor Induction

  Percentage of participants able to achieve vaginal delivery within 24 hours of labor induction.

  Within 24 hours of labor induction

Secondary Outcomes (20)

• Time to Vaginal Delivery

  Start of induction until vaginal delivery

• Time to Delivery

  Until delivery

• Time to Active Labor

  Until active labor

• Rates of Vaginal Delivery

  Until delivery

• Cesarean Delivery Rate

  Until delivery

Study Arms (2)

Buccal misoprostol+placebo vaginal pill

EXPERIMENTAL

Drug: Buccal Misoprostol

Vaginal Misoprostol+placebo buccal pill

ACTIVE COMPARATOR

Drug: Vaginal misoprostol

Interventions

Buccal Misoprostol DRUG

Buccal rather than Vaginal misoprostol for induction of labor

Also known as: Cytotec

Buccal misoprostol+placebo vaginal pill

Vaginal misoprostol DRUG

Vaginal rather than buccal misoprostol for induction of labor

Also known as: Cytotec

Vaginal Misoprostol+placebo buccal pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willingness to participate / consent in a placebo-controlled trial
• Age 18 and older
• Pregnancy between 34 and 42 years of gestation
• Admitted for labor induction because of either medical, obstetric, or psychosocial indications
• Live singleton fetus
• Bishop score less than or equal to six
• Cephalic presentation
• Reactive non-stress test or Negative contraction test

You may not qualify if:

• Premature rupture of membranes
• Multiparity \> 5
• Contraindication to vaginal or labor delivery
• Suspected placental abruption
• Significant hepatic, renal or cardiac disease
• Known hypersensitivity to misoprostol or prostaglandin analogue
• Recent prostaglandin administration for induction of labor
• Multifetal pregnancy
• Macrosomia \> 4500g estimated fetal weight by ultrasound or leopold

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Links

• UCLA Department of Obstetrics and Gynecology

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 to the trial were termination of study due to poor recruitment, leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Linh Tran
• Organization: Stanford University

lltran20@gmail.com

925-642-2241

Study Officials

• Ram Parvataneni, MD

  Associate Clinical Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 27, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 27, 2016
• Results First Posted: September 27, 2016

Record last verified: 2016-08

Locations

US (1)