NCT02720991

A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Abortion, 3 Months

Interventions

Type	Name	Description
DRUG	Mifepristone	200 mg of oral mifepristone
DRUG	Sublingual misoprostol	400 ug of misoprostol sublingually following mifepristone

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2016-03-28
• Last updated: 2016-03-28