Clinical trial NCT03714880: Cervical Preparation With Mifepristone Prior to Osmotic Dilators
Official title: Cervical Preparation With Mifepristone Prior to Osmotic Dilators: A Randomized, Double-blind, Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Second Trimester Abortion
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2018-10-22
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants That Had Placement of Expected Dilators or More
timeFrame: At time of 1 hour clinic visit (10 minutes)
Secondary outcomes:
measure: Cervical Dilation
timeFrame: At time of ~1 hour scheduled procedure time (1 minute)
measure: Number of Participants That Required Mechanical Dilation
timeFrame: At time of ~1 hour scheduled procedure time (10 minute)
measure: Pain Dilator Placement Using Visual Analog Scale
timeFrame: At time of 1 hour clinic visit (10 minutes)
measure: Provider Assessment of Procedure as "Very Easy" or "Easy"
timeFrame: At time of ~1 hour scheduled procedure time
measure: Number of Participants That Experienced Complications
timeFrame: At time of ~1 hour scheduled procedure time (0-30 minute)
measure: Number of Participants That Required Mechanical Dilation
timeFrame: At time of ~1 hour scheduled procedure time
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Obstetrics and Gynecology
state: California
Study officials:
References: