A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks
NCT ID: NCT02720991
Last Updated: 2016-03-28
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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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2014-07-31
2015-04-30
Brief Summary
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Detailed Description
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The first 5 women enrolled in each gestational age group will be asked to return to the clinic 24-48 hours after the initial visit to take misoprostol at the clinic and wait during a 3 hour observational period before returning to their homes. After this initial phase, the women will be asked to self-administer the misoprostol at home 24-48 hours after the administration of mifepristone and to return to the clinic 7-10 days later. At follow-up, a healthcare provider will assure her that her medical abortion is complete and after will ask women to respond to a series of questions in an exit interview.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mifepristone and sublingual misoprostol
200 mg mifepristone and 400 ug sublingual misoprostol
Mifepristone
200 mg of oral mifepristone
Sublingual misoprostol
400 ug of misoprostol sublingually following mifepristone
Interventions
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Mifepristone
200 mg of oral mifepristone
Sublingual misoprostol
400 ug of misoprostol sublingually following mifepristone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Seeking abortion services
* Prepared and able to sign the consent forms
* Accept to conform to study procedures and scheduled visits
Exclusion Criteria
FEMALE
Yes
Sponsors
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Hopital La Rabta
OTHER
Gynuity Health Projects
OTHER
Responsible Party
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Other Identifiers
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1014
Identifier Type: -
Identifier Source: org_study_id
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