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Cervical Preparation With Mifepristone Prior to Osmotic Dilators

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ClinicalTrials.gov Identifier: NCT03714880
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




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



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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 20 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714880


Contacts
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Contact: Mitchell D Creinin, MD (916) 734-6670 mdcreinin@ucdavis.edu
Contact: Suji Uhm, MD, MPH sujiuhm@gmail.com

Locations
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United States, California
UC Davis Department of Obstetrics and Gynecology Recruiting
Sacramento, California, United States, 95817
Contact: Suji Uhm, MD, MPH         
Sponsors and Collaborators
University of California, Davis
Society of Family Planning
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03714880    
Other Study ID Numbers: 1317056
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

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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:
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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
Menstruation-Inducing Agents