<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/NCT03014193</url>
  </required_header>
  <id_info>
    <org_study_id>6009</org_study_id>
    <nct_id>NCT03014193</nct_id>
  </id_info>
  <brief_title>Simplifying First Trimester Medical Abortion Follow-up</brief_title>
  <official_title>Simplifying First Trimester Medical Abortion Follow-up</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 evaluates the usability of the multilevel pregnancy test among women undergoing&#xD;
      medical abortion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Understanding of the instructions for the multilevel pregnancy test</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ability to independently use the multilevel pregnancy tests</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Ability to interpret the results of the multilevel pregnancy test</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Medical Abortion</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Semiquantitative Multi-Level Pregnancy Test</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women seeking medical abortion with pregnancies of 63 days or less.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a first trimester pregnancy with a gestational age of ≤63 days;&#xD;
&#xD;
          -  Desire medical abortion with mifepristone and misoprostol and be medically eligible&#xD;
             for that treatment, according to clinic protocol;&#xD;
&#xD;
          -  Be able to read and understand the local language or Russian;&#xD;
&#xD;
          -  Have access to a telephone;&#xD;
&#xD;
          -  Agree to follow all study procedures;&#xD;
&#xD;
          -  Have no contraindication to participation in the study, in the judgment of the site&#xD;
             investigator or designee.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gyumri Maternity Hospital</name>
      <address>
        <city>Gyumri</city>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology</name>
      <address>
        <city>Yerevan</city>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Batumi International Hospital</name>
      <address>
        <city>Batumi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Gagua Clinic</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Policlinic #17</name>
      <address>
        <city>Almaty</city>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Armenia</country>
    <country>Georgia</country>
    <country>Kazakhstan</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>November 1, 2017</last_update_submitted>
  <last_update_submitted_qc>November 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03014193
org study id: 6009
nct id: NCT03014193
lead sponsor: 
This study evaluates the usability of the multilevel pregnancy test among women undergoing
      medical abortion.
observational model: Case-Only
time perspective: Prospective
measure: Understanding of the instructions for the multilevel pregnancy test
time frame: 14 days
measure: Ability to independently use the multilevel pregnancy tests
time frame: 14 days
measure: Ability to interpret the results of the multilevel pregnancy test
time frame: 14 days
intervention type: Device
intervention name: Semiquantitative Multi-Level Pregnancy Test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: Armenia
country: Georgia
country: Kazakhstan
responsible party type: Sponsor