Cervical Preparation With Mifepristone Prior to Osmotic Dilators

NCT03714880 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 1317056
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to study the role of mifepristone prior to the placement of cervical osmotic dilators to evaluate if the medication helps increase the number of dilators. This may help improve safety of dilation and evacuation (D\&E) procedures.

Conditions

Second Trimester Abortion

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Had Placement of Expected Dilators or More

  The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as "Yes, participant had placement of expected dilators or more."

  At time of 1 hour clinic visit (10 minutes)

Secondary Outcomes (6)

• Cervical Dilation

  At time of ~1 hour scheduled procedure time (1 minute)

• Number of Participants That Required Mechanical Dilation

  At time of ~1 hour scheduled procedure time (10 minute)

• Pain Dilator Placement Using Visual Analog Scale

  At time of 1 hour clinic visit (10 minutes)

• Provider Assessment of Procedure as "Very Easy" or "Easy"

  At time of ~1 hour scheduled procedure time

• Number of Participants That Experienced Complications

  At time of ~1 hour scheduled procedure time (0-30 minute)

Study Arms (2)

Mifepristone

EXPERIMENTAL

Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement

Drug: Mifepristone 200 MG

Placebo

PLACEBO COMPARATOR

Participants ingest placebo oral medication once 18-24 hours prior to dilator placement

Drug: Placebo Oral Tablet

Interventions

Mifepristone 200 MG DRUG

Ingestion of study medication vs placebo

Mifepristone

Placebo Oral Tablet DRUG

Ingestion of study medication vs placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing to sign informed consent and follow study protocol

You may not qualify if:

• A. Allergy or known intolerance to mifepristone
• B. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:
• Chronic adrenal failure or insufficiency
• Concurrent use of long-term corticosteroid therapy
• Inherited porphyrias
• C. Any condition that in the opinion of the investigator could impede study participation or collection of study data

Sponsors & Collaborators

• University of California, Davis: lead
• Society of Family Planning: collaborator

Study Sites (1)

UC Davis Department of Obstetrics and Gynecology

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Suji Uhm, MD, MPH
• Organization: University of Pittsburgh

uhms@upmc.edu

412-641-4590

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: April 26, 2019
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-06

Locations

US (1)