Status:
COMPLETED
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
Lead Sponsor:
Gynuity Health Projects
Conditions:
Abortion, First Trimester
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, an...
Eligibility Criteria
Inclusion
- 18 years or older
- 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
- Eligible for medical abortion according to the clinician's assessment
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT02219100
Start Date
November 1 2010
End Date
November 1 2011
Last Update
August 19 2014
Active Locations (5)
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1
Gyumri Maternity Hospital
Gyumri, Armenia
2
Vanadzor Hospital #1
Vanadzor, Armenia
3
Antenatal Clinic
Ganja, Azerbaijan
4
Family Planning Center
Ganja, Azerbaijan