Cervical Preparation With Mifepristone Prior to Osmotic Dilators

Second Trimester Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03714880
• Other study ID #: 1317056
• Status: Terminated
• Phase: Phase 2
• Start date: April 26, 2019
• Est. completion date: February 26, 2021

Study information

• Verified date: June 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Second Trimester Abortion

Intervention

Drug:
• Mifepristone 200 MG
Ingestion of study medication vs placebo
• Placebo Oral Tablet
Ingestion of study medication vs placebo

Locations

Country	Name	City	State
United States	UC Davis Department of Obstetrics and Gynecology	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cervical Dilation	Measurement of cervical dilation at time of procedure	At time of ~1 hour scheduled procedure time (1 minute)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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