Cervical Preparation With Mifepristone Prior to Osmotic Dilators

University of California (UC) Davis

Status and phase: Terminated; Phase 2

Conditions: Second Trimester Abortion

Treatments: Drug: Mifepristone 200 MG; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03714880

1317056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups, including a placebo group

Mifepristone

Experimental group

Description:

Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement

Treatment:

Drug: Mifepristone 200 MG

Placebo

Placebo Comparator group

Description:

Participants ingest placebo oral medication once 18-24 hours prior to dilator placement

Treatment:

Drug: Placebo Oral Tablet