Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Second Trimester Abortion

Intervention / Treatment
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* Drug: Mifepristone 200 MG
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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: Chronic adrenal failure or insufficiency Concurrent use of long-term corticosteroid therapy Inherited porphyrias C. Any condition that in the opinion of the investigator could impede study participation or collection of study data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone<br>Participants ingest mifepristone 200 mg oral medication once 18-24 hours prior to dilator placement | Drug: Mifepristone 200 MG<br>* Ingestion of study medication vs placebo<br>|
| Placebo Comparator: Placebo<br>Participants ingest placebo oral medication once 18-24 hours prior to dilator placement | Drug: Placebo Oral Tablet<br>* Ingestion of study medication vs placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Had Placement of Expected Dilators or More | The number of expected dilators (Dilapan-S) is calculated based on the gestational age. Four dilators are expected to be placed at 18 weeks 0 days to 19 weeks 6 days gestation. Five dilators are expected to be placed at 20 weeks 0 days to 20 weeks 6 days gestation. Six dilators are expected to be placed at 21 weeks 0 days to 21 weeks 6 days gestation. Seven dilators are expected to be placed at 22 weeks 0 days to 23 weeks 5 days gestation. Therefore, at any given gestational age, if the expected number of dilators (or additional dilators) were placed, the participant was counted as Yes, participant had placement of expected dilators or more. | At time of 1 hour clinic visit (10 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Dilation | Measurement of cervical dilation at time of procedure | At time of  1 hour scheduled procedure time (1 minute) | 
| Number of Participants That Required Mechanical Dilation | A count of the number of participants that required of mechanical dilation at time of procedure | At time of  1 hour scheduled procedure time (10 minute) | 
| Pain Dilator Placement Using Visual Analog Scale | Title: Pain at time of dilator placement. Participants mark their associated pain score on a 10-cm visual analog scale at time of dilator placement with anchors of no pain at 0 cm and worst pain in your life at 10 cm. Higher scores indicate worse outcome. | At time of 1 hour clinic visit (10 minutes) | 
| Provider Assessment of Procedure as Very Easy or Easy | Survey providers blinded to study grouping regarding overall ease of procedure based on cervical dilation Identified procedures that were categorized as Very Easy or Easy (Survey response based on Likert scale: Very Easy, Easy, Moderate, Difficult, Very Difficult) | At time of  1 hour scheduled procedure time | 
| Number of Participants That Experienced Complications | Composite of complications including cervical lacerations requiring repair, perforations, blood transfusions, ED visits, hospitalizations, infections, additional surgical procedures, or extramural deliveries | At time of  1 hour scheduled procedure time (0-30 minute) | 
| Number of Participants That Required Mechanical Dilation | Number of participants that required mechanical dilation at time of procedure | At time of  1 hour scheduled procedure time |