<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/NCT02191774</url>
  </required_header>
  <id_info>
    <org_study_id>Marions 2014 1.2</org_study_id>
    <secondary_id>2013-004749-18</secondary_id>
    <nct_id>NCT02191774</nct_id>
  </id_info>
  <brief_title>Medical Abortion up to 10 Weeks Gestation at Home</brief_title>
  <official_title>Medical Abortion up to 10 Weeks Gestation at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medical abortion performed in the womens home has shown to be safe and acceptable up to 9&#xD;
      weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally&#xD;
      effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of&#xD;
      gestation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 600 women opting for medical abortion. Women wanting to perform the&#xD;
      last part of the abortion in their homes will be invited to participate. 300 women with a&#xD;
      pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation&#xD;
      length between 64 and 70 days of gestation. The primary endpoints will be number of patients&#xD;
      with an incomplete abortion, with a need for surgical or pharmaceutical intervention.&#xD;
&#xD;
      Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method&#xD;
      and number of additional visits to the clinic/facility.&#xD;
&#xD;
      The study will be performed in five abortion clinics in Sweden.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of incomplete abortions</measure>
    <time_frame>4 weeks after treatment</time_frame>
    <description>Need for surgical or pharmaceutical intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of bleeding</measure>
    <time_frame>4 weeks after treatment</time_frame>
    <description>Measured by diary and questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and satisfaction of treatment</measure>
    <time_frame>4 weeks after treatment</time_frame>
    <description>Questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of additional visits to the clinic</measure>
    <time_frame>4 weeks after treatment</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">273</enrollment>
  <condition>Pregnancy Complications</condition>
  <condition>Legally Induced Abortion Without Mention of Complication</condition>
  <arm_group>
    <arm_group_label>Gestational length up to 63 days</arm_group_label>
    <description>Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gestational length 64-70 days</arm_group_label>
    <description>Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Medical abortion at home</intervention_name>
    <description>Medical abortion using Mifepristone at the clinic followed by Cytotec at home</description>
    <arm_group_label>Gestational length 64-70 days</arm_group_label>
    <arm_group_label>Gestational length up to 63 days</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with an unwanted pregnancy opting for medical abortion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Requesting and eligible for medical abortion&#xD;
&#xD;
          -  Confirmed intrauterine pregnancy&#xD;
&#xD;
          -  Gestational length no more than 70 days&#xD;
&#xD;
          -  Hemoglobin over 100g/l&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  Contraindication to mifepristone (steroid-dependant cancer, porphyria)&#xD;
&#xD;
          -  Breast feeding&#xD;
&#xD;
          -  Advanced pregnancy (&gt;70 days)&#xD;
&#xD;
          -  Known liver disease&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Arterial hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lena Marions, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Södersjukhuset</name>
      <address>
        <city>Stockholm</city>
        <zip>118 83</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>June 21, 2022</last_update_submitted>
  <last_update_submitted_qc>June 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Lena Marions</investigator_full_name>
    <investigator_title>Associate professor, senior consultant</investigator_title>
  </responsible_party>
  <keyword>Medical abortion</keyword>
  <keyword>Home abortion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02191774
org study id: Marions 2014 1.2
secondary id: 2013-004749-18
nct id: NCT02191774
lead sponsor: 
has dmc: Yes
Medical abortion performed in the womens home has shown to be safe and acceptable up to 9
      weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally
      effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of
      gestation.
The study will include 600 women opting for medical abortion. Women wanting to perform the
      last part of the abortion in their homes will be invited to participate. 300 women with a
      pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation
      length between 64 and 70 days of gestation. The primary endpoints will be number of patients
      with an incomplete abortion, with a need for surgical or pharmaceutical intervention.

      Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method
      and number of additional visits to the clinic/facility.

      The study will be performed in five abortion clinics in Sweden.
observational model: Cohort
time perspective: Prospective
measure: Number of incomplete abortions
time frame: 4 weeks after treatment
description: Need for surgical or pharmaceutical intervention
measure: Duration of bleeding
time frame: 4 weeks after treatment
description: Measured by diary and questionnaires
measure: Acceptance and satisfaction of treatment
time frame: 4 weeks after treatment
description: Questionnaires
measure: Number of additional visits to the clinic
time frame: 4 weeks after treatment
arm group label: Gestational length up to 63 days
description: Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later
arm group label: Gestational length 64-70 days
description: Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later
intervention type: Procedure
intervention name: Medical abortion at home
description: Medical abortion using Mifepristone at the clinic followed by Cytotec at home
arm group label: Gestational length 64-70 days
arm group label: Gestational length up to 63 days
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lena Marions, MD PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Lena Marions
investigator title: Associate professor, senior consultant
mesh term: Pregnancy Complications
sharing ipd: No