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Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219100
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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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, and buccal administration of misoprostol, would be both acceptable to women and efficacious.

Condition or disease Intervention/treatment Phase
Abortion, First Trimester Drug: Home administration of 200 mg mifepristone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Home administration of mifepristone
This arm consisted of women who chose home administration of 200 mg mifepristone.
 Drug: Home administration of 200 mg mifepristone
Home administration of 200 mg mifepristone
No Intervention: Clinic administration of mifepristone
This arm consisted of women who underwent clinic administration of 200 mg mifepristone.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of abortions that are complete without surgical intervention (unit: percent). [ Time Frame: 15 days ]
    Percentage of women with complete abortion without the need of a surgical intervention.


Secondary Outcome Measures :
  1. Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent). [ Time Frame: 15 days ]
    Woman's satisfaction with her medical abortion procedure and side effects experienced.


Other Outcome Measures:
  1. Proportion of Women Who Select Home-use of Mifepristone [ Time Frame: 1 week ]
  2. Proportion of Women Who Select Home-use of Misoprostol [ Time Frame: 1 week ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219100


Locations
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Armenia
Gyumri Maternity Hospital
Gyumri, Armenia
Vanadzor Hospital #1
Vanadzor, Armenia
Azerbaijan
Antenatal Clinic
Gandja, Azerbaijan
Family Planning Center
Gandja, Azerbaijan
Gynecology Department of the Central Regional Hospital
Zaqatala, Azerbaijan
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
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
More Information
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02219100    
Other Study ID Numbers: 1.2.3.1
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
 Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents