Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Phase 2

Terminated

• Conditions: Second Trimester Abortion
• Interventions: Drug: Mifepristone 200 MG; Drug: Placebo Oral Tablet

• Registration Number: NCT03714880
• Lead Sponsor: University of California, Davis

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.

Detailed Description

No clear guideline currently exists for best practices involving cervical preparation for women planning dilation and evacuation at 20 weeks and greater. The investigators plan to perform a pilot, randomized, double-blind, placebo-controlled trial. On day 1, 66 participants will receive mifepristone 200 mg orally or placebo 18-24 hours prior to osmotic dilator (Dilapan-S 4-mm) placement (day 2). On day 3, participants will have a D\&E procedure. Enrollees will be 18 weeks 0 days to 23 weeks 6 days gestation on the day of the procedure. The primary objective is to evaluate the role of adjunctive mifepristone the day prior to osmotic dilator placement for dilation and evacuation procedures. The primary outcome will be the number of dilators successfully placed. Investigators will compare the number of dilators placed between study arms stratified by gestational age. Secondary outcomes include cervical dilation at time of procedure, proportion of women requiring mechanical dilation at time of surgery, provider impression on ease of procedure and/or difficulty in dilating the cervix when clinically required, and overall complications. Complications or adverse events include cervical laceration requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infection, additional surgical procedures, or extramural deliveries.

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2019-04-26
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Results First Submitted: 2022-03-30
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Results First Posted: 2022-06-08
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

A. Allergy or known intolerance to mifepristone

B. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:

1. Chronic adrenal failure or insufficiency
2. Concurrent use of long-term corticosteroid therapy
3. Inherited porphyrias

C. Any condition that in the opinion of the investigator could impede study participation or collection of study data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifepristone	Mifepristone 200 MG	Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement
Placebo	Placebo Oral Tablet	Participants ingest placebo oral medication once 18-24 hours prior to dilator placement

Primary Outcome Measures

Name	Time	Method
Number of Participants That Had Placement of Expected Dilators or More	At time of 1 hour clinic visit (10 minutes)	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."

Secondary Outcome Measures

Name	Time	Method
Cervical Dilation	At time of ~1 hour scheduled procedure time (1 minute)	Measurement of cervical dilation at time of procedure
Number of Participants That Required Mechanical Dilation	At time of ~1 hour scheduled procedure time	Number of participants that required mechanical dilation at time of procedure
Pain Dilator Placement Using Visual Analog Scale	At time of 1 hour clinic visit (10 minutes)	Title: Pain at time of dilator placement. Participants mark their associated pain score on a 10-cm visual analog scale at time of dilator placement with anchors of "no pain" at 0 cm and "worst pain in your life" at 10 cm.; Higher scores indicate worse outcome.
Provider Assessment of Procedure as "Very Easy" or "Easy"	At time of ~1 hour scheduled procedure time	Survey providers blinded to study grouping regarding overall ease of procedure based on cervical dilation Identified procedures that were categorized as "Very Easy" or "Easy" (Survey response based on Likert scale: "Very Easy," "Easy," "Moderate," "Difficult," "Very Difficult")
Number of Participants That Experienced Complications	At time of ~1 hour scheduled procedure time (0-30 minute)	Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries

Trial Locations

Locations (1)

UC Davis Department of Obstetrics and Gynecology; 🇺🇸 Sacramento, California, United States