Abortion, Therapeutic Clinical Trial
Official title:
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
Verified date | June 2018 |
Source | Gynuity Health Projects |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Ukraine | Lviv Municipal Women's Consultation No. 2 | L'viv | |
Ukraine | Vinnitsa Regional Clinical Hospital | Vinnitsa |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects | Charitable Foundation Women Health & Family Planning |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of successful abortion | 2 weeks after mifepristone administration |
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