Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Second Trimester Abortion
• Intervention / Treatment: Drug: Mifepristone 200 MG; Drug: Placebo Oral Tablet

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone; Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement	Drug: Mifepristone 200 MG; Ingestion of study medication vs placebo
Placebo Comparator: Placebo; Participants ingest placebo oral medication once 18-24 hours prior to dilator placement	Drug: Placebo Oral Tablet; Ingestion of study medication vs placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Dilation	Measurement of cervical dilation at time of procedure	At time of ~1 hour scheduled procedure time (1 minute)
Number of Participants That Required Mechanical Dilation	A count of the number of participants that required of mechanical dilation at time of procedure	At time of ~1 hour scheduled procedure time (10 minute)
Pain Dilator Placement Using Visual Analog Scale	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.	At time of 1 hour clinic visit (10 minutes)
Provider Assessment of Procedure as "Very Easy" or "Easy"	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")	At time of ~1 hour scheduled procedure time
Number of Participants That Experienced Complications	Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries	At time of ~1 hour scheduled procedure time (0-30 minute)
Number of Participants That Required Mechanical Dilation	Number of participants that required mechanical dilation at time of procedure	At time of ~1 hour scheduled procedure time

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Society of Family Planning

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): February 26, 2021

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: 1317056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes