24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E

NCT03134183 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HM20005740
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal misoprostol for cervical preparation for second trimester dilation and evacuation (D\&E).

Conditions

Abortion, Second Trimester

Keywords

D&E; dilation and evacuation; abortion; second trimester; mifepristone; misoprostol

Outcome Measures

Primary Outcomes (1)

• Procedure Time

  Time from initial uterine instrumentation to speculum out

  At end of procedure

Secondary Outcomes (1)

• Cervical Dilation

  At end of procedure

Study Arms (2)

Vaginal Misoprostol

EXPERIMENTAL

Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository

Drug: Vaginal Misoprostol

Buccal Misoprostol

EXPERIMENTAL

Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder

Drug: Buccal Misoprostol

Interventions

Vaginal Misoprostol DRUG

Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D\&E

Also known as: cytotec

Vaginal Misoprostol

Buccal Misoprostol DRUG

Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D\&E

Also known as: cytotec

Buccal Misoprostol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D\&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent.

You may not qualify if:

• Emergent need for D\&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Frances Casey, MD
• Organization: Virginia Commonwealth University

frances.casey@vcuhealth.org

804-828-5076

Study Officials

• Frances Casey, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Computer-generated randomization will be utilized to assign treatment arms and the vaginal misoprostol and buccal placebo and buccal misoprostol and vaginal placebo will be prepared according to randomization scheme by the research pharmacy in opaque-sealed envelopes as to blind participants and providers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: November 19, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 18, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)