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

Phase 4

Completed

• Conditions: Abortion, 3 Months
• Interventions: Drug: Mifepristone; Drug: Sublingual misoprostol

• Registration Number: NCT02720991
• Lead Sponsor: Gynuity Health Projects

Brief 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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-03
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-22
• Last Update Submitted: 2016-03-22
• Study First Posted: 2016-03-28
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mifepristone and sublingual misoprostol	Sublingual misoprostol	200 mg mifepristone and 400 ug sublingual misoprostol
Mifepristone and sublingual misoprostol	Mifepristone	200 mg mifepristone and 400 ug sublingual misoprostol

Primary Outcome Measures

Name	Time	Method
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	1 week

Secondary Outcome Measures

Name	Time	Method
Level of tolerance of side effects, based on responses to questionnaire	1 week