Mifepristone
Drug200 mg of oral mifepristone
Other names: miropristone, Mifeprex, Mifegyn
Completed
NCT Number: NCT02720991
A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks
A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.
Completed
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About this study
The study will enroll 25 women in each gestational age group. All participants will be submitted to routine screening as per current practice at La Rabta Hospital. The eligible women will receive a dose of 200 mg of mifepristone and 400 ug of misoprostol to take at home sublingually .
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Gestational age of 71-84 days of amenorrhea
- Seeking abortion services
- Prepared and able to sign the consent forms
- Accept to conform to study procedures and scheduled visits
Exclusion criteria
- Does not meet study criteria
Treatment and study plan
Sublingual misoprostol
Drug400 ug of misoprostol sublingually following mifepristone
Other names: cytotec
Primary outcomes
-
Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire
Time frame: 1 week
Secondary outcomes
-
Level of tolerance of side effects, based on responses to questionnaire
Time frame: 1 week
Sponsors and collaborators
Lead sponsor
Gynuity Health Projects
Other
Collaborators
- Hopital La Rabta
Registry information
Official study title
A Pilot Study of the Acceptability and Feasibility of an Out-patient Regimen of Medical Abortion With Mifepristone and 400 mcg Sublingual Misoprostol at 71-77 and 78-84 Days Gestation
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Mar 28, 2016
- Registry last updated
- Mar 28, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.