xml: <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/NCT05975112</url>
    </required_header>
    <id_info>
      <org_study_id>13</org_study_id>
      <nct_id>NCT05975112</nct_id>
    </id_info>
    <brief_title>The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section</brief_title>
    <official_title>The Incidence of Hyperfibrinolysis During Vaginal Delivery and Cesarean Section</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Graz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Graz</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to find out if there are common major changes in coagulation immediately&#xD;
        after delivery of the newborn during Cesarean (C) -section and vaginal birth.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postpartum Hemorrhage (PPH) is a potentially life-threatening complication of labour and a&#xD;
        leading cause of maternal mortality and morbidity. It is defined as a blood loss of 500ml or&#xD;
        more in the first 24 hours after birth and it is estimated that about 2% of all parturients&#xD;
        are affected. Postpartum hemorrhage is responsible for 8% of maternal deaths in in&#xD;
        industrialized nations. The prophylactic use of an uterotonic agent is suggested to reduce&#xD;
        the risk of postpartum bleeding.&#xD;
  &#xD;
        Tranexamic acid has become another candidate for the prevention of postpartum hemorrhage over&#xD;
        the past ten years. It has an antifibrinolytic effect and inhibits hyperfibrinolysis, its&#xD;
        clinical effects have been demonstrated in several contexts. In clinical trials outside of&#xD;
        obstetrics, tranexamic acid has been found to reduce the need for transfusions during&#xD;
        elective procedures and to reduce mortality in patients with extra- or intracranial trauma.&#xD;
        In recent studies it is suggested to administer Tranexamic acid already prophylactically&#xD;
        during cesarean delivery to reduce blood loss and avoid hyperfibrinolysis and PPH.&#xD;
  &#xD;
        What is not known, is how often patients are affected by hyperfibrinolysis during cesarean&#xD;
        section and vaginal birth without it manifesting as PPH. In trauma patients, for example,&#xD;
        hyperfibrinolysis was found in 5% and moderate hyperfibrinolysis in 57%.&#xD;
  &#xD;
        It is unusual to establish a prophylactic treatment without any data on the incidence of the&#xD;
        condition, which is aimed to be treated. Therefore, the aim of the study is to provide a data&#xD;
        basis for the incidence of hyperfibrinolysis after vaginal delivery and cesarean section.&#xD;
  &#xD;
        Primary Aim:&#xD;
  &#xD;
        The aim of this study is to quantify the incidence of hyperfibrinolysis during natural birth&#xD;
        and C-section. For this purpose, maternal blood is drawn after the baby's cord is cut and&#xD;
        analyzed using thrombelastography with the addition of tranexamic acid. In addition, the&#xD;
        following parameters are examined:&#xD;
  &#xD;
          -  Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)&#xD;
  &#xD;
          -  Level of D-Dimer&#xD;
  &#xD;
        Secondary objectives&#xD;
  &#xD;
          -  Mode of delivery (Vaginal delivery/ C-Section)&#xD;
  &#xD;
          -  Time cut to delivery as marker for increased manipulation&#xD;
  &#xD;
          -  Duration of birth in vaginal delivery? Onset of labor until delivery?&#xD;
  &#xD;
          -  Number of previous births&#xD;
  &#xD;
          -  Weeks of gestation&#xD;
  &#xD;
          -  Obstetrical risk factors (multiple gestation, polyhydramnios, prolonged labour, fever)&#xD;
  &#xD;
          -  Height / weight of parturient&#xD;
  &#xD;
          -  ASA (American Society of Anesthesiologists) status&#xD;
  &#xD;
          -  Anticoagulant drugs&#xD;
  &#xD;
        At discharge from the delivery room, approximately 6 hours after delivery, hemoglobin levels&#xD;
        are checked by noninvasive hemoglobin measurement (Rad-67™ Spot-check Pulse CO-Oximeter®&#xD;
        (Masimo Corporation, Irvine, CA) and blood drawing as part of routine clinical practice. In&#xD;
        this way, the extent of blood loss can be estimated, and as a further objective the&#xD;
        investigators can also verify the usability of spHb (continuous total hemoglobin) measurement&#xD;
        in the delivery room.&#xD;
  &#xD;
        The usefulness of continuously measuring SpHb in a perioperative setting has previously been&#xD;
        described. Several studies have shown that SpHb can help to estimate Hb values in various&#xD;
        settings and to reduce unnecessary red blood cell (RBC) transfusions.&#xD;
  &#xD;
        In the delivery room setting, the spHb value could serve as an additional tool to reduce&#xD;
        unnecessary testing without the cost of overlooking anemic patients in the future.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">April 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Incidence of Hyperfibrinolysis</measure>
      <time_frame>immediate after birth</time_frame>
      <description>Ly30-Index is used as marker for Hyperfibrinolysis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>D-dimer</measure>
      <time_frame>immediate after birth</time_frame>
      <description>D-dimer level</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">780</enrollment>
    <condition>Hyperfibrinolysis</condition>
    <condition>Cesarean Section Complications</condition>
    <condition>Coagulation Defect; Bleeding</condition>
    <condition>Peripartum Haemorrhage</condition>
    <arm_group>
      <arm_group_label>cesarean section</arm_group_label>
      <description>maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:&#xD;
  Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)&#xD;
  Level of hs-D-Dimer&#xD;
  SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>vaginal delivery</arm_group_label>
      <description>maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:&#xD;
  Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)&#xD;
  Level of hs-D-Dimer&#xD;
  SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before discharge</intervention_name>
      <description>Coagulation tests named earlier as well as SpHb</description>
      <arm_group_label>cesarean section</arm_group_label>
      <arm_group_label>vaginal delivery</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        one blood sample of 6ml&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          780 women after giving birth to a child, 390 in each group&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 18 years and older with a singleton or multiple pregnancy who volunteer for&#xD;
               the present study and give one blood sample of 6ml&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Age &lt; 18 years&#xD;
  &#xD;
            2. Emergency cesarean section&#xD;
  &#xD;
            3. History of thrombocytopathy or coagulation disorders&#xD;
  &#xD;
            4. Therapy with drugs that influence thrombocyte function and coagulation (ASS less than&#xD;
               5 days ago, clopidogrel, prasugrel, ticagrelor or similar)&#xD;
  &#xD;
            5. Lack of consent&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Philipp Zoidl, MD</last_name>
      <phone>004331638584659</phone>
      <email>philipp.zoidl@medunigraz.at</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical University of Graz</name>
        <address>
          <city>Graz</city>
          <state>Styria</state>
          <zip>8010</zip>
          <country>Austria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Philipp Zoidl, MD</last_name>
        <email>philipp.zoidl@medunigraz.at</email>
      </contact>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Hemostatic Disorders</mesh_term>
      <mesh_term>Blood Coagulation Disorders</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Plasminogen</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975112
  org study id: 13
  nct id: NCT05975112
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to find out if there are common major changes in coagulation immediately
        after delivery of the newborn during Cesarean (C) -section and vaginal birth.
  Postpartum Hemorrhage (PPH) is a potentially life-threatening complication of labour and a
        leading cause of maternal mortality and morbidity. It is defined as a blood loss of 500ml or
        more in the first 24 hours after birth and it is estimated that about 2% of all parturients
        are affected. Postpartum hemorrhage is responsible for 8% of maternal deaths in in
        industrialized nations. The prophylactic use of an uterotonic agent is suggested to reduce
        the risk of postpartum bleeding.
  
        Tranexamic acid has become another candidate for the prevention of postpartum hemorrhage over
        the past ten years. It has an antifibrinolytic effect and inhibits hyperfibrinolysis, its
        clinical effects have been demonstrated in several contexts. In clinical trials outside of
        obstetrics, tranexamic acid has been found to reduce the need for transfusions during
        elective procedures and to reduce mortality in patients with extra- or intracranial trauma.
        In recent studies it is suggested to administer Tranexamic acid already prophylactically
        during cesarean delivery to reduce blood loss and avoid hyperfibrinolysis and PPH.
  
        What is not known, is how often patients are affected by hyperfibrinolysis during cesarean
        section and vaginal birth without it manifesting as PPH. In trauma patients, for example,
        hyperfibrinolysis was found in 5% and moderate hyperfibrinolysis in 57%.
  
        It is unusual to establish a prophylactic treatment without any data on the incidence of the
        condition, which is aimed to be treated. Therefore, the aim of the study is to provide a data
        basis for the incidence of hyperfibrinolysis after vaginal delivery and cesarean section.
  
        Primary Aim:
  
        The aim of this study is to quantify the incidence of hyperfibrinolysis during natural birth
        and C-section. For this purpose, maternal blood is drawn after the baby's cord is cut and
        analyzed using thrombelastography with the addition of tranexamic acid. In addition, the
        following parameters are examined:
  
          -  Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)
  
          -  Level of D-Dimer
  
        Secondary objectives
  
          -  Mode of delivery (Vaginal delivery/ C-Section)
  
          -  Time cut to delivery as marker for increased manipulation
  
          -  Duration of birth in vaginal delivery? Onset of labor until delivery?
  
          -  Number of previous births
  
          -  Weeks of gestation
  
          -  Obstetrical risk factors (multiple gestation, polyhydramnios, prolonged labour, fever)
  
          -  Height / weight of parturient
  
          -  ASA (American Society of Anesthesiologists) status
  
          -  Anticoagulant drugs
  
        At discharge from the delivery room, approximately 6 hours after delivery, hemoglobin levels
        are checked by noninvasive hemoglobin measurement (Rad-67™ Spot-check Pulse CO-Oximeter®
        (Masimo Corporation, Irvine, CA) and blood drawing as part of routine clinical practice. In
        this way, the extent of blood loss can be estimated, and as a further objective the
        investigators can also verify the usability of spHb (continuous total hemoglobin) measurement
        in the delivery room.
  
        The usefulness of continuously measuring SpHb in a perioperative setting has previously been
        described. Several studies have shown that SpHb can help to estimate Hb values in various
        settings and to reduce unnecessary red blood cell (RBC) transfusions.
  
        In the delivery room setting, the spHb value could serve as an additional tool to reduce
        unnecessary testing without the cost of overlooking anemic patients in the future.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of Hyperfibrinolysis
  time frame: immediate after birth
  description: Ly30-Index is used as marker for Hyperfibrinolysis
  measure: D-dimer
  time frame: immediate after birth
  description: D-dimer level
  arm group label: cesarean section
  description: maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:
  Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)
  Level of hs-D-Dimer
  SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine.
  arm group label: vaginal delivery
  description: maternal blood is drawn immediately after the baby's cord is cut and analyzed using thrombelastography with the addition of tranexamic acid. In addition, the following parameters are examined:
  Levels of Factor 1 (Fibrinogen) and Factor 2 (Thrombin)
  Level of hs-D-Dimer
  SpHb is measured before discharge from the delivery room in order to estimate blood loss and to be able to make a comparison with the level of Hb measured in the laboratory as part of clinical routine.
  intervention type: Diagnostic Test
  intervention name: Coagulation tests (TEG, Levels of F1, F2, hs-D-dimer, Plasminogen, PAI 1+2), SpHb before discharge
  description: Coagulation tests named earlier as well as SpHb
  arm group label: cesarean section
  arm group label: vaginal delivery
  one blood sample of 6ml
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Philipp Zoidl, MD
  phone: 004331638584659
  email: philipp.zoidl@medunigraz.at
  facility: 
  status: Recruiting
  contact: 
  country: Austria
  responsible party type: Sponsor
  mesh term: Hemostatic Disorders
  mesh term: Blood Coagulation Disorders
  mesh term: Hemorrhage
  mesh term: Plasminogen
  sharing ipd: Undecided