<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/NCT04409015</url>
  </required_header>
  <id_info>
    <org_study_id>2020H0119</org_study_id>
    <nct_id>NCT04409015</nct_id>
  </id_info>
  <brief_title>ROTEM® Obstetric Hemorrhage Pilot Study</brief_title>
  <official_title>ROTEM® Obstetric Hemorrhage Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational study among women at high-risk of postpartum hemorrhage,&#xD;
      in their third trimester who are admitted to Labor &amp;Delivery in spontaneous labor, for&#xD;
      induction of labor, or for scheduled cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 30, 2021</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>Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.</measure>
    <time_frame>After delivery through study completion, an average of 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.</measure>
    <time_frame>Pre and post-delivery through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating volume of estimated and quantitative blood loss</measure>
    <time_frame>Pre and post-delivery through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating change in hemoglobin/hematocrit ratio between values on admission for delivery (or in the last 4 weeks prior to delivery) and at 24 (+/-4) hours postpartum</measure>
    <time_frame>Pre and post-delivery through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss &gt;500ml for vaginal delivery and &gt;1000ml for cesarean delivery</measure>
    <time_frame>Pre and post-delivery through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating frequency of blood transfusion and related morbidities</measure>
    <time_frame>Pre and post-delivery through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)</measure>
    <time_frame>Pre and post-delivery through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH)</measure>
    <time_frame>Pre and post-delivery through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>High Risk Postpartum Hemorrhage (PPH)</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ROTEM - rotation thromboelastometry testing</intervention_name>
    <description>The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with high risk of postpartum hemorrhage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years and able to provide consent&#xD;
&#xD;
          2. Gestational age ≥ 34 weeks&#xD;
&#xD;
          3. ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:&#xD;
&#xD;
               1. Nulliparous women admitted for induction of labor with unfavorable cervix&#xD;
                  (Bishop's score &lt;5)&#xD;
&#xD;
               2. Prior uterine surgery (&gt; 1 prior cesarean or myomectomy)&#xD;
&#xD;
               3. Patients undergoing trial of labor after cesarean delivery&#xD;
&#xD;
               4. History of postpartum hemorrhage&#xD;
&#xD;
               5. ≥4 previous vaginal deliveries&#xD;
&#xD;
               6. Multiple gestation&#xD;
&#xD;
               7. The presence of &gt; 2 uterine fibroids or fibroid &gt; 5 cm on any ultrasound during&#xD;
                  the pregnancy&#xD;
&#xD;
               8. Planned magnesium sulfate use&#xD;
&#xD;
               9. Placenta previa/accreta/increta/percreta&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to&#xD;
             sample collection is not an exclusion)&#xD;
&#xD;
          2. Antepartum hemorrhage present on admission (&gt;500cc Estimated Blood Loss (EBL))&#xD;
&#xD;
          3. Coagulation defects&#xD;
&#xD;
          4. Thrombocytopenia with platelets count &lt;100,000&#xD;
&#xD;
          5. Enrolled in the &quot;Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After&#xD;
             Cesarean (TXA)&quot; (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior&#xD;
             to enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Michael Cackovic</investigator_full_name>
    <investigator_title>MD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>High risk Postpartum hemorrhage (PPH)</keyword>
  <keyword>ROTEM</keyword>
  <keyword>pregnant women</keyword>
  <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>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/NCT04409015
org study id: 2020H0119
nct id: NCT04409015
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a prospective observational study among women at high-risk of postpartum hemorrhage,
      in their third trimester who are admitted to Labor &Delivery in spontaneous labor, for
      induction of labor, or for scheduled cesarean section.
observational model: Case-Only
time perspective: Prospective
measure: Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
time frame: After delivery through study completion, an average of 2 years
measure: Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.
time frame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating volume of estimated and quantitative blood loss
time frame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating change in hemoglobin/hematocrit ratio between values on admission for delivery (or in the last 4 weeks prior to delivery) and at 24 (+/-4) hours postpartum
time frame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery
time frame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating frequency of blood transfusion and related morbidities
time frame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)
time frame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH)
time frame: Pre and post-delivery through study completion, an average of 2 years
intervention type: Device
intervention name: ROTEM - rotation thromboelastometry testing
description: The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Michael Cackovic
investigator title: MD, Associate Professor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: No