<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02219100</url>
  </required_header>
  <id_info>
    <org_study_id>1.2.3.1</org_study_id>
    <nct_id>NCT02219100</nct_id>
  </id_info>
  <brief_title>Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus</brief_title>
  <official_title>Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gynuity Health Projects</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gynuity Health Projects</source>
  <brief_summary>
    <textblock>
      This study examined the acceptability and feasibility of using a simplified regimen of&#xD;
      medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone&#xD;
      and misoprostol, and buccal administration of misoprostol, would be both acceptable to women&#xD;
      and efficacious.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of abortions that are complete without surgical intervention (unit: percent).</measure>
    <time_frame>15 days</time_frame>
    <description>Percentage of women with complete abortion without the need of a surgical intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).</measure>
    <time_frame>15 days</time_frame>
    <description>Woman's satisfaction with her medical abortion procedure and side effects experienced.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of Women Who Select Home-use of Mifepristone</measure>
    <time_frame>1 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Women Who Select Home-use of Misoprostol</measure>
    <time_frame>1 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">613</enrollment>
  <condition>Abortion, First Trimester</condition>
  <arm_group>
    <arm_group_label>Home administration of mifepristone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm consisted of women who chose home administration of 200 mg mifepristone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic administration of mifepristone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm consisted of women who underwent clinic administration of 200 mg mifepristone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Home administration of 200 mg mifepristone</intervention_name>
    <description>Home administration of 200 mg mifepristone</description>
    <arm_group_label>Home administration of mifepristone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
          -  Living or working close to the study site&#xD;
&#xD;
          -  Intrauterine pregnancy less than 64 days gestation&#xD;
&#xD;
          -  Willing and able to sign consent forms&#xD;
&#xD;
          -  Eligible for medical abortion according to the clinician's assessment&#xD;
&#xD;
          -  Ready access to a telephone and emergency transportation&#xD;
&#xD;
          -  Willing to provide an address and/or telephone number for purposes of follow-up&#xD;
&#xD;
          -  Agree to comply with the study procedures and visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass&#xD;
&#xD;
          -  IUD in place (IUD must be removed first)&#xD;
&#xD;
          -  Chronic renal failure&#xD;
&#xD;
          -  Concurrent long-term corticosteroid therapy&#xD;
&#xD;
          -  History of allergy to mifepristone, misoprostol or other prostaglandin&#xD;
&#xD;
          -  Hemorrhagic disorders or concurrent anticoagulant therapy&#xD;
&#xD;
          -  Inherited porphyrias&#xD;
&#xD;
          -  Other serious physical or mental health conditions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beverly Winikoff, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rena Bagirova, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Antenatal Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mehriban Huseynova, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynecology Department of the Central Regional Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aram Avalyan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanadzor Hospital #1</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alla Minasyan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gyumri Maternity Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gyumri Maternity Hospital</name>
      <address>
        <city>Gyumri</city>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanadzor Hospital #1</name>
      <address>
        <city>Vanadzor</city>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antenatal Clinic</name>
      <address>
        <city>Gandja</city>
        <country>Azerbaijan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Planning Center</name>
      <address>
        <city>Gandja</city>
        <country>Azerbaijan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gynecology Department of the Central Regional Hospital</name>
      <address>
        <city>Zaqatala</city>
        <country>Azerbaijan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Armenia</country>
    <country>Azerbaijan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mifepristone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219100
org study id: 1.2.3.1
nct id: NCT02219100
lead sponsor: 
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of abortions that are complete without surgical intervention (unit: percent).
time frame: 15 days
description: Percentage of women with complete abortion without the need of a surgical intervention.
measure: Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).
time frame: 15 days
description: Woman's satisfaction with her medical abortion procedure and side effects experienced.
measure: Proportion of Women Who Select Home-use of Mifepristone
time frame: 1 week
measure: Proportion of Women Who Select Home-use of Misoprostol
time frame: 1 week
arm group label: Home administration of mifepristone
arm group type: Experimental
description: This arm consisted of women who chose home administration of 200 mg mifepristone.
arm group label: Clinic administration of mifepristone
arm group type: No Intervention
description: This arm consisted of women who underwent clinic administration of 200 mg mifepristone.
intervention type: Drug
intervention name: Home administration of 200 mg mifepristone
description: Home administration of 200 mg mifepristone
arm group label: Home administration of mifepristone
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Beverly Winikoff, MD, MPH
role: Principal Investigator
affiliation: Gynuity Health Projects
last name: Rena Bagirova, MD
role: Principal Investigator
affiliation: Antenatal Clinic
last name: Mehriban Huseynova, MD
role: Principal Investigator
affiliation: Gynecology Department of the Central Regional Hospital
last name: Aram Avalyan, MD
role: Principal Investigator
affiliation: Vanadzor Hospital #1
last name: Alla Minasyan, MD
role: Principal Investigator
affiliation: Gyumri Maternity Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: Armenia
country: Azerbaijan
responsible party type: Sponsor
mesh term: Mifepristone