Cervical Preparation With Mifepristone Prior to Osmotic Dilators

• ClinicalTrials.gov Identifier: NCT03714880
• Recruitment Status: Terminated
• First Posted: October 22, 2018
• Last Update Posted: August 16, 2021
• Sponsor: University of California, Davis
• Collaborator: Society of Family Planning
• Information provided by (Responsible Party): University of California, Davis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Second Trimester Abortion	Drug: Mifepristone 200 MG; Drug: Placebo Oral Tablet	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study
• Actual Study Start Date: April 26, 2019
• Actual Primary Completion Date: February 26, 2021
• Actual Study Completion Date: February 26, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of osmotic dilators [ Time Frame: At time of 1 hour clinic visit (10 minutes) ]
   Number of dilators placed prior to D&E procedure

Secondary Outcome Measures :

1. Placement of appropriate number of dilators [ Time Frame: At time of 1 hour clinic visit (10 minutes) ]
   Evaluate the number of women having placement of the appropriate number of dilators the day prior to the procedure based on this university's standard protocol
2. Cervical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (1 minute) ]
   Measurement of cervical dilation at time of procedure
3. Mechanical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (10 minute) ]
   Requirement of mechanical dilation at time of procedure
4. Pain dilator placement using visual analog scale [ Time Frame: At time of 1 hour clinic visit (10 minutes) ]
   Participants will mark level of pain or discomfort on a 10 cm line marked at left side with "no pain" and right side labelled as "worst pain"
5. Pain medications [ Time Frame: 18-24 hours between dilator placement (visit 2) and procedure (visit 3) ]
   Number of tablets utilized for ibuprofen and Tylenol #3 after dilator placement
6. Provider survey to ease of procedure and difficulty in dilation, if necessary [ Time Frame: At time of ~1 hour scheduled procedure time ]
   Survey providers blinded to study grouping regarding 1) overall ease of procedure based on cervical dilation and 2) difficulty in dilating the cervix when clinically required
7. Number of complications [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

UC Davis Department of Obstetrics and Gynecology

Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Society of Family Planning

More Information

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03714880
• Other Study ID Numbers: 1317056
• First Posted: October 22, 2018
• Last Update Posted: August 16, 2021
• Last Verified: August 2021

• 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

Additional relevant MeSH terms:

Mifepristone; Abortifacient Agents, Steroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral, Synthetic; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Luteolytic Agents; Contraceptive Agents, Hormonal; Menstruation-Inducing Agents