Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine
- Registration Number
- NCT02981030
- Lead Sponsor
- Gynuity Health Projects
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 102
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Simplified medical abortion Mifepristone Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home. Simplified medical abortion Misoprostol Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home.
- Primary Outcome Measures
Name Time Method Rate of successful abortion 2 weeks after mifepristone administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Vinnitsa Regional Clinical Hospital
🇺🇦Vinnitsa, Ukraine
Lviv Municipal Women's Consultation No. 2
🇺🇦L'viv, Ukraine