Overview

Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
Female
Summary
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynuity Health Projects
Treatments:
Mifepristone
Misoprostol
Criteria
Inclusion Criteria:

- At least 18 years old

- In good general health

- Living or working close to the study site

- Intrauterine pregnancy less than 64 days gestation

- Willing and able to sign consent forms

- Ready access to a telephone and emergency transportation

- Willing to provide an address and/or telephone number for purposes of follow-up

- Agree to comply with the study procedures and visit schedule

Exclusion Criteria:

- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass

- IUD in place (IUD must be removed first)

- Chronic renal failure

- Concurrent long-term corticosteroid therapy

- History of allergy to mifepristone, misoprostol or other prostaglandin

- Hemorrhagic disorders or concurrent anticoagulant therapy

- Inherited porphyrias

- Other serious physical or mental health conditions