Complete Abortion
Conditions
Brief summary
The study will be conducted in 4 sites and 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 Kazakhstan. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and sublingual administration of 600 µg misoprostol with gestations through 70 days, as well as the acceptability of this method. Research questions include: 1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by 600 µg sublingual misoprostol and used in gestations of up to 70 days? 2. Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan? 3. Are the side effects associated with sublingual use of misoprostol acceptable to women? 4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?
Interventions
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol
Sponsors
Gynuity Health Projects
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of successful abortion | 2 weeks after mifepristone administration |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction with method | 2 weeks or up to 30 days after mifepristone administration |
Other
| Measure | Time frame |
|---|---|
| Number of days missed work/school for women choosing mifepristone administration outside the clinic and those who choose its administration at the clinic | 2 weeks after mifepristone administration |
| Side effects | 2 weeks after mifepristone administration |
| Acceptability of the side effects and of sublingual administration | 2 weeks after mifepristone administration |
| Complications, including heavy bleeding or infection requiring additional treatment | 2 weeks after mifepristone administration |
Countries
Kazakhstan
Outcome results
None listed