- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679092
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Withdrawn
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
-
-
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.
|
osmotic cervical dilators inserted through the internal os
Other Names:
|
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.
|
osmotic cervical dilators inserted through the internal os
Other Names:
400 mcg buccal 60-90 minutes prior to procedure
Other Names:
|
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.
|
400 mcg buccal 60-90 minutes prior to procedure
Other Names:
200 mg PO on the day prior to D&E
Other Names:
|
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.
|
400 mcg buccal 60-90 minutes prior to procedure
Other Names:
200 mg PO on the day prior to D&E
Other Names:
|
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
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
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Anti-Ulcer Agents
- Contraceptives, Oral, Synthetic
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Luteolytic Agents
- Abortifacient Agents, Steroidal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Menstruation-Inducing Agents
- Misoprostol
- Mifepristone
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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