Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
Overview
- Phase
- Phase 4
- Intervention
- Mifepristone
- Conditions
- Abortion, Therapeutic
- Sponsor
- Gynuity Health Projects
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Rate of successful abortion
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with gestations through 70 days, as well as the acceptability of this method.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have an intrauterine pregnancy consistent with gestational age less than 71 days;
- •Be able to understand and willing to sign a consent form;
- •Be eligible for medical abortion according to the clinician's assessment;
- •Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
- •Be 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;
- •Chronic renal failure;
- •Concurrent long-term corticosteroid therapy;
- •History of allergy to mifepristone, or misoprostol or another prostaglandin;
- •History of hemorrhagic disorders or concurrent anticoagulant therapy;
- •History of inherited porphyrias;
- •Intrauterine device in place (must be removed before mifepristone is administered).
Arms & Interventions
Simplified medical abortion
Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.
Intervention: Mifepristone
Simplified medical abortion
Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.
Intervention: Misoprostol
Outcomes
Primary Outcomes
Rate of successful abortion
Time Frame: 2 weeks after mifepristone administration