ClinicalTrials.gov
ClinicalTrials.gov Menu

Cervical Preparation With Mifepristone Prior to Osmotic Dilators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03714880
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Suji Uhm, University of California, Davis

Brief Summary:
We 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 D&Es.

Condition or disease Intervention/treatment Phase
Abortion in Second Trimester 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 20 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  (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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

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. 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)

  2. Cervical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (1 minute) ]
    Measurement of cervical dilation at time of procedure

  3. 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"

  4. 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

  5. Mechanical dilation [ Time Frame: At time of ~1 hour scheduled procedure time (10 minute) ]
    Requirement of mechanical dilation at time of procedure

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Signed consent for surgical D&E procedure
  • gestational age between 20 weeks 0 days to 23 weeks 6 days
  • English-speaking/reading

Exclusion Criteria:

  • Allergy or contraindication to mifepristone
  • Any condition that in the opinion of the investigator could impede study participation or collection of study data

Responsible Party: Suji Uhm, Clinical Fellow, University of California, Davis
ClinicalTrials.gov Identifier: NCT03714880     History of Changes
Other Study ID Numbers: 1317056-1
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

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
Menstruation-Inducing Agents