Abortion, First Trimester Clinical Trial
Official title:
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
Verified date | August 2014 |
Source | Gynuity Health Projects |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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, and buccal administration of misoprostol, would be both acceptable to women and efficacious.
Status | Completed |
Enrollment | 613 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Armenia | Gyumri Maternity Hospital | Gyumri | |
Armenia | Vanadzor Hospital #1 | Vanadzor | |
Azerbaijan | Antenatal Clinic | Gandja | |
Azerbaijan | Family Planning Center | Gandja | |
Azerbaijan | Gynecology Department of the Central Regional Hospital | Zaqatala |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects |
Armenia, Azerbaijan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of Women Who Select Home-use of Mifepristone | 1 week | No | |
Other | Proportion of Women Who Select Home-use of Misoprostol | 1 week | No | |
Primary | Proportion of abortions that are complete without surgical intervention (unit: percent). | Percentage of women with complete abortion without the need of a surgical intervention. | 15 days | No |
Secondary | Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent). | Woman's satisfaction with her medical abortion procedure and side effects experienced. | 15 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00386282 -
Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol
|
N/A | |
Completed |
NCT02398838 -
Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia
|
N/A |