Abortion, 3 Months Clinical Trial
Official 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
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment