- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219100
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
August 18, 2014 updated by: Gynuity Health Projects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
613
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gyumri, Armenia
- Gyumri Maternity Hospital
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Vanadzor, Armenia
- Vanadzor Hospital #1
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Gandja, Azerbaijan
- Antenatal Clinic
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Gandja, Azerbaijan
- Family planning center
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Zaqatala, Azerbaijan
- Gynecology Department of the Central Regional Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home administration of mifepristone
This arm consisted of women who chose home administration of 200 mg mifepristone.
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Home administration of 200 mg mifepristone
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No Intervention: Clinic administration of mifepristone
This arm consisted of women who underwent clinic administration of 200 mg mifepristone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of abortions that are complete without surgical intervention (unit: percent).
Time Frame: 15 days
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Percentage of women with complete abortion without the need of a surgical intervention.
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15 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).
Time Frame: 15 days
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Woman's satisfaction with her medical abortion procedure and side effects experienced.
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15 days
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of Women Who Select Home-use of Mifepristone
Time Frame: 1 week
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1 week
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Proportion of Women Who Select Home-use of Misoprostol
Time Frame: 1 week
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1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rena Bagirova, MD, Antenatal Clinic
- Principal Investigator: Mehriban Huseynova, MD, Gynecology Department of the Central Regional Hospital
- Principal Investigator: Aram Avalyan, MD, Vanadzor Hospital #1
- Principal Investigator: Alla Minasyan, MD, Gyumri Maternity Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
July 29, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Estimate)
August 19, 2014
Last Update Submitted That Met QC Criteria
August 18, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Abortifacient Agents
- Luteolytic Agents
- Abortifacient Agents, Steroidal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Menstruation-Inducing Agents
- Mifepristone
Other Study ID Numbers
- 1.2.3.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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