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

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Abortion, 3 Months

Treatments: Drug: Sublingual misoprostol; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT02720991

1014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Mifepristone and sublingual misoprostol

Experimental group

Description:

200 mg mifepristone and 400 ug sublingual misoprostol

Treatment:

Drug: Mifepristone

Drug: Sublingual misoprostol