Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
NCT ID: NCT02679092
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-04-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os
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.
Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os
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.
Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Mifepristone
200 mg PO on the day prior to D\&E
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.
Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Mifepristone
200 mg PO on the day prior to D\&E
Interventions
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Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Mifepristone
200 mg PO on the day prior to D\&E
Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Planned Parenthood Mar Monte
San Jose, California, United States
Countries
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Other Identifiers
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IRB-36302
Identifier Type: -
Identifier Source: org_study_id
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