<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/NCT04474704</url>
  </required_header>
  <id_info>
    <org_study_id>2020H0264</org_study_id>
    <nct_id>NCT04474704</nct_id>
  </id_info>
  <brief_title>Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia</brief_title>
  <official_title>Use of Cheetah® Non-invasive Cardiac Monitoring System to Guide Discontinuation of Postpartum Magnesium Sulfate in Women With Severe Preeclampsia: A Pilot Randomized Control Trial</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 single site pilot randomized, controlled, trial randomizing patients with PE with&#xD;
      severe features to one of 2 groups:&#xD;
&#xD;
        -  24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
&#xD;
        -  Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.</measure>
    <time_frame>up to 24 hours postpartum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of Postpartum Adverse Outcomes</measure>
    <time_frame>up to 4 weeks after delivery</time_frame>
    <description>any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as &gt;160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating Incidence of Need to Restart Magnesium Sulfate</measure>
    <time_frame>up to 1 week postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating Number of Participants With Hospital Readmission for Preeclampsia</measure>
    <time_frame>up to 4 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Acute Anti-hypertensive Medications</measure>
    <time_frame>Up to 5 days after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for More Than 1 Dose of Anti-hypertensive Medication</measure>
    <time_frame>Up to 5 days after delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Preeclampsia With Severe Features</condition>
  <arm_group>
    <arm_group_label>Cheetah® non-invasive cardiac monitoring system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cheetah® non-invasive cardiac monitoring system</intervention_name>
    <description>Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
    <arm_group_label>Cheetah® non-invasive cardiac monitoring system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>24 hours of postpartum magnesium sulfate</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preeclampsia with severe features, diagnosed using the American Congress of&#xD;
             Obstetricians and Gynecologists (ACOG) standard criteria 4 requiring magnesium sulfate&#xD;
&#xD;
          -  Females older than 18 years of age&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Gestational age greater than 24 0/7 weeks&#xD;
&#xD;
          -  The patient is physically and mentally able to understand the informed consent and is&#xD;
             willing to participate in this study&#xD;
&#xD;
          -  Able to speak English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients with chronic renal insufficiency or epilepsy&#xD;
&#xD;
          -  Known cardiovascular disease&#xD;
&#xD;
          -  Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis)&#xD;
&#xD;
          -  Patients with eclampsia or HELLP syndrome&#xD;
&#xD;
          -  Contraindications for magnesium sulfate&#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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maged Costantine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <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>June 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <results_first_submitted>May 11, 2023</results_first_submitted>
  <results_first_submitted_qc>June 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2023</results_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Maged Costantine</investigator_full_name>
    <investigator_title>MD, Professor</investigator_title>
  </responsible_party>
  <keyword>preeclampsia with severe features</keyword>
  <keyword>magnesium sulfate</keyword>
  <keyword>Systemic Vascular Resistance</keyword>
  <keyword>non-invasive cardiac monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 31, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04474704/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
          <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
          <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31" spread="5.5"/>
                    <measurement group_id="B2" value="30" spread="5.5"/>
                    <measurement group_id="B3" value="30.4" spread="5.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic ethnicity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nulliparity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI at delivery</title>
          <units>Kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.3" spread="7.7"/>
                    <measurement group_id="B2" value="39.1" spread="9.9"/>
                    <measurement group_id="B3" value="38.3" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age at delivery</title>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36" lower_limit="33" upper_limit="37"/>
                    <measurement group_id="B2" value="36" lower_limit="34" upper_limit="38"/>
                    <measurement group_id="B3" value="36" lower_limit="33.5" upper_limit="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.</title>
        <time_frame>up to 24 hours postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
            <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" spread="4.7"/>
                    <measurement group_id="O2" value="24" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Composite of Postpartum Adverse Outcomes</title>
        <description>any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as &gt;160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia</description>
        <time_frame>up to 4 weeks after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
            <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
          </group>
        </group_list>
        <measure>
          <title>Composite of Postpartum Adverse Outcomes</title>
          <description>any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as &gt;160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluating Incidence of Need to Restart Magnesium Sulfate</title>
        <time_frame>up to 1 week postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
            <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluating Incidence of Need to Restart Magnesium Sulfate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluating Number of Participants With Hospital Readmission for Preeclampsia</title>
        <time_frame>up to 4 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
            <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluating Number of Participants With Hospital Readmission for Preeclampsia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Acute Anti-hypertensive Medications</title>
        <time_frame>Up to 5 days after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
            <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Acute Anti-hypertensive Medications</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Need for More Than 1 Dose of Anti-hypertensive Medication</title>
        <time_frame>Up to 5 days after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
            <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
          </group>
        </group_list>
        <measure>
          <title>Need for More Than 1 Dose of Anti-hypertensive Medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>After up to 4 weeks postpartum</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cheetah® Non-invasive Cardiac Monitoring System</title>
          <description>Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.&#xD;
Cheetah® non-invasive cardiac monitoring system: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>24 hours of postpartum magnesium sulfate (current arbitrary standard of care)&#xD;
Standard of care: 24 hours of postpartum magnesium sulfate</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Maged Costantine, MD</name_or_title>
      <organization>The Ohio State University</organization>
      <phone>614-293-2222</phone>
      <email>Maged.Costantine@osumc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04474704
org study id: 2020H0264
nct id: NCT04474704
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a single site pilot randomized, controlled, trial randomizing patients with PE with
      severe features to one of 2 groups:

        -  24 hours of postpartum magnesium sulfate (current arbitrary standard of care)

        -  Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
time frame: up to 24 hours postpartum
measure: Composite of Postpartum Adverse Outcomes
time frame: up to 4 weeks after delivery
description: any of the following: use of acute anti-hypertensive medications for persistently severe range blood pressure (defined as >160/110 persistent after 15 min), need for more than one dose of acute anti-hypertensive medications, need to restart Mg (for persistent neurological symptoms), postpartum readmission for PE, as well as the development of pulmonary edema, HELLP, or eclampsia
measure: Evaluating Incidence of Need to Restart Magnesium Sulfate
time frame: up to 1 week postpartum
measure: Evaluating Number of Participants With Hospital Readmission for Preeclampsia
time frame: up to 4 weeks postpartum
measure: Use of Acute Anti-hypertensive Medications
time frame: Up to 5 days after delivery
measure: Need for More Than 1 Dose of Anti-hypertensive Medication
time frame: Up to 5 days after delivery
arm group label: Cheetah® non-invasive cardiac monitoring system
arm group type: Experimental
description: Using the Cheetah® device to aid in an individualized duration of magnesium sulfate based on reduction in Systemic Vascular Resistance (SVR), up to a maximum of 24 hours postpartum.
arm group label: Standard of care
arm group type: Other
description: 24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
intervention type: Device
intervention name: Cheetah® non-invasive cardiac monitoring system
description: Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))
arm group label: Cheetah® non-invasive cardiac monitoring system
intervention type: Other
intervention name: Standard of care
description: 24 hours of postpartum magnesium sulfate
arm group label: Standard of care
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maged Costantine, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Maged Costantine
investigator title: MD, Professor
mesh term: Pre-Eclampsia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 