Summary

for females ages 18-45 (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Second Trimester AbortionMifepristoneMifepristone 200 MG

Eligibility

You can join if…

Open to females ages 18-45

  1. 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

You CAN'T join if...

  1. Allergy or known intolerance to mifepristone
  2. Known contraindication to mifepristone for cervical preparation prior to dilation and evacuation:
  3. Chronic adrenal failure or insufficiency
  4. Concurrent use of long-term corticosteroid therapy
  5. Inherited porphyrias
  6. Current fetal demise
  7. Any condition that in the opinion of the investigator could impede study participation or collection of study data

Location

  • UC Davis Department of Obstetrics and Gynecology accepting new patients
    SacramentoCalifornia95817United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT03714880
Phase
Phase 2
Study Type
Interventional
Last Updated