Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia

Gynuity Health Projects

Status: Completed

Conditions: Induced Abortion

Treatments: Drug: Mifepristone, misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01173003

1.1.7

Details and patient eligibility

About

This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.

The goal of this study is to provide answers to the following four questions:

1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Are women satisfied with counseling and services received in new centers offering medical abortion?

Enrollment: 688 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women presenting for medical abortion who consent to participate
• Possibility of final gestational age of less than or equal to 63 days
• General good health
• Willing to provide contact information for purposes of follow-up

Exclusion criteria

• Conditions which contraindicate the use of mifepristone or misoprostol
• Women presenting for medical abortion who do not consent to participate

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)