<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/NCT04444856</url>
  </required_header>
  <id_info>
    <org_study_id>NN7711-4729</org_study_id>
    <secondary_id>EUPAS35429</secondary_id>
    <secondary_id>U1111-1248-2816</secondary_id>
    <nct_id>NCT04444856</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern</brief_title>
  <official_title>Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Retrospective Single-centre Cohort Study at the University Hospital of Bern</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This non-interventional study will compare the clinical outcomes in women with an event of&#xD;
      severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an&#xD;
      event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a&#xD;
      single centre retrospective cohort study of women with an event of severe postpartum&#xD;
      haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of&#xD;
      2005-2016.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">January 13, 2021</completion_date>
  <primary_completion_date type="Actual">January 13, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)</measure>
    <time_frame>20 min-24 hours following time 0</time_frame>
    <description>Count of participants (yes/no)&#xD;
Time 0 definition for all endpoints:&#xD;
Timescale for matching is time (in hours and minutes) since onset of sPPH. For exposed women: Time 0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time 0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of thromboembolic events (yes/no)</measure>
    <time_frame>From time 0 until 5 days after time 0</time_frame>
    <description>Count of participants (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of blood products transfused</measure>
    <time_frame>From delivery to 24 hours after time 0</time_frame>
    <description>Units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>From delivery to 24 hours after time 0</time_frame>
    <description>mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of hysterectomy (yes/no)</measure>
    <time_frame>20 min-24 hours following time 0</time_frame>
    <description>Count of participants (yes/no)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">225</enrollment>
  <condition>Severe Postpartum Haemorrhage</condition>
  <arm_group>
    <arm_group_label>NovoSeven</arm_group_label>
    <description>Women with severe postpartum haemorrhage treated with NovoSeven</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <description>Women with severe postpartum haemorrhage treated with standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eptacog alfa (activated)</intervention_name>
    <description>The women included in the study population have been treated with NovoSeven® (eptacog alfa (activated)) according to local routine clinical practice at the discretion of the treating physician.</description>
    <arm_group_label>NovoSeven</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other&#xD;
        standard of care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females&#xD;
&#xD;
          -  sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after&#xD;
             delivery&#xD;
&#xD;
          -  Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study&#xD;
             cohort and new cohort)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Reporting Anchor and Disclosure (1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bern</city>
        <zip>CH-3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>&quot;According to the Novo Nordisk disclosure commitment on novonordisk-trials.com&quot;</ipd_description>
    <ipd_url>http://novonordisk-trials.com</ipd_url>
  </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/NCT04444856
org study id: NN7711-4729
secondary id: EUPAS35429
secondary id: U1111-1248-2816
nct id: NCT04444856
lead sponsor: 
has dmc: No
is fda regulated device: No
This non-interventional study will compare the clinical outcomes in women with an event of
      severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an
      event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a
      single centre retrospective cohort study of women with an event of severe postpartum
      haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of
      2005-2016.
observational model: Cohort
time perspective: Retrospective
measure: Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)
time frame: 20 min-24 hours following time 0
description: Count of participants (yes/no)
Time 0 definition for all endpoints:
Timescale for matching is time (in hours and minutes) since onset of sPPH. For exposed women: Time 0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time 0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control.
measure: Occurrence of thromboembolic events (yes/no)
time frame: From time 0 until 5 days after time 0
description: Count of participants (yes/no)
measure: Amount of blood products transfused
time frame: From delivery to 24 hours after time 0
description: Units
measure: Estimated blood loss
time frame: From delivery to 24 hours after time 0
description: mL
measure: Occurrence of hysterectomy (yes/no)
time frame: 20 min-24 hours following time 0
description: Count of participants (yes/no)
arm group label: NovoSeven
description: Women with severe postpartum haemorrhage treated with NovoSeven
arm group label: Standard of care
description: Women with severe postpartum haemorrhage treated with standard of care
intervention type: Drug
intervention name: Eptacog alfa (activated)
description: The women included in the study population have been treated with NovoSeven® (eptacog alfa (activated)) according to local routine clinical practice at the discretion of the treating physician.
arm group label: NovoSeven
intervention type: Other
intervention name: Standard of care
description: The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.
arm group label: Standard of care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Reporting Anchor and Disclosure (1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: Yes
ipd description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
ipd url: http://novonordisk-trials.com