Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

September 17, 2019 updated by: Stanford University
Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95126
        • Planned Parenthood Mar Monte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • >18 Years Old
  • Viable, Singleton pregnancy
  • Voluntarily seeking abortion between 14-19 weeks gestation
  • Able to give informed consent and comply with study protocol
  • Fluent in English or Spanish

Exclusion Criteria:

  • Allergy to study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dilapan (14wks 0days-15wks, 6days)
The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.
Device: Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os
Other Names:
  • Dilapan-S
ACTIVE_COMPARATOR: Dilapan (16wks 0days-18wks, 6days)
The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Device: Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os
Other Names:
  • Dilapan-S
Drug: Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Other Names:
  • Cytotec
EXPERIMENTAL: Mifepristone (14wks 0days-15wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Drug: Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Other Names:
  • Cytotec
Drug: Mifepristone
200 mg PO on the day prior to D&E
Other Names:
  • Mifeprex
  • Danco
EXPERIMENTAL: Mifepristone (16wks 0days-18wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Drug: Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Other Names:
  • Cytotec
Drug: Mifepristone
200 mg PO on the day prior to D&E
Other Names:
  • Mifeprex
  • Danco

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Time
Time Frame: Intraoperative
Measured as time from speculum insertion to removal.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Dilation
Time Frame: Baseline
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure
Baseline
Total Procedure Time
Time Frame: Measured at clinic visit and on OR day, over 2 day period
All time required by patient (time in clinic for cervical preparation procedures)
Measured at clinic visit and on OR day, over 2 day period
Difficulty of Procedure, as reported by clinician
Time Frame: Measured within 5 minutes after procedure
Using Visual Analogue Scale (VAS)
Measured within 5 minutes after procedure
Complications/Adverse Events
Time Frame: Intraoperatively
Estimated blood loss, uterine injury, infection, retained products of conception
Intraoperatively
Pain Perceived by Patient
Time Frame: Intraoperatively "Measured during dilator placement"
Using Visual Analogue Scale (VAS)
Intraoperatively "Measured during dilator placement"
Overall Patient Experience
Time Frame: Measured post-operatively (30 minutes prior to discharge)
Using Visual Analogue Scale (VAS)
Measured post-operatively (30 minutes prior to discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (ESTIMATE)

February 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-36302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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