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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

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE April 26, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Number of osmotic dilators [ Time Frame: At time of 1 hour clinic visit (10 minutes) ]
Number of dilators placed prior to D&E procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • 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
  • Cervical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (1 minute) ]
    Measurement of cervical dilation at time of procedure
  • Mechanical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (10 minute) ]
    Requirement of mechanical dilation at time of procedure
  • 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"
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Dumbbelling [ Time Frame: At time of ~1 hour scheduled procedure time (1 minute) ]
    Degree of dumbbelling at time of dilator removal ("dumbbelling" refers to narrowing of osmotic dilators, usually at the level of the internal os)
  • Cervical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (1 minute) ]
    Measurement of cervical dilation at time of procedure
  • 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"
  • 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
  • Mechanical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (10 minute) ]
    Requirement of mechanical dilation at time of procedure
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Preparation With Mifepristone Prior to Osmotic Dilators
Official Title  ICMJE Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Second Trimester Abortion
Intervention  ICMJE
  • Drug: Mifepristone 200 MG
    Ingestion of study medication vs placebo
  • Drug: Placebo Oral Tablet
    Ingestion of study medication vs placebo
Study Arms  ICMJE
  • Experimental: Mifepristone
    Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement
    Intervention: Drug: Mifepristone 200 MG
  • Placebo Comparator: Placebo
    Participants ingest placebo oral medication once 18-24 hours prior to dilator placement
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mitchell D Creinin, MD (916) 734-6670 mdcreinin@ucdavis.edu
Contact: Suji Uhm, MD, MPH sujiuhm@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03714880
Other Study ID Numbers  ICMJE 1317056
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP