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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Abortion, 3 Months

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Sublingual misoprostol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone and sublingual misoprostol<br>200 mg mifepristone and 400 ug sublingual misoprostol | Drug: Mifepristone<br>* 200 mg of oral mifepristone<br>* Other names: Mifegyn;Drug: Sublingual misoprostol<br>* 400 ug of misoprostol sublingually following mifepristone<br>* Other names: cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of tolerance of side effects, based on responses to questionnaire |  | 1 week |