<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/NCT03244865</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00009835</org_study_id>
    <nct_id>NCT03244865</nct_id>
  </id_info>
  <brief_title>Refinement of the OBMedical LaborView System</brief_title>
  <official_title>Refinement of LaborView Electronic Fetal Monitor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OBMedical Company</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OBMedical Company</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>
      Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal&#xD;
      well-being during labor or preparation for cesarean delivery. Current monitoring methods:&#xD;
      transabdominal ultrasound (CTG: cardiotocograph) and fetal scalp electrodes (FSE) have&#xD;
      limitations (tracing loss during fetal movement, potential to confuse maternal for fetal&#xD;
      heart rate, inability to monitor during cesarean section or abdominal surgery) and, in the&#xD;
      latter case, risks (infection, hematoma). A reliable, non-invasive monitor of the fetal heart&#xD;
      rate that can be used during labor, non-obstetric and obstetric surgery during pregnancy is&#xD;
      needed. Recent developments in use of maternal abdominal electrodes for extraction of the FHR&#xD;
      and contraction information inform this study.&#xD;
&#xD;
      LaborView®, developed by researchers at University of Florida (UF) College of Medicine and&#xD;
      OBMedical, is an FDA-approved non-invasive labor monitoring device. Refinement of the&#xD;
      extraction algorithms continues, and that work is most effectively performed at UF, where the&#xD;
      primary researchers and OBMedical are located.&#xD;
&#xD;
      LaborView monitoring will be recorded from up to150 subjects admitted to Labor and Delivery&#xD;
      at UFHealth. Data will be simultaneously obtained from the standard labor monitor. These&#xD;
      signals will then be analyzed off-line for comparison and refinement of algorithms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal&#xD;
      well being during labor. Typically, continuous electronic fetal monitoring is via&#xD;
      transabdominal ultrasound (CTG: cardiotocograph). A transducer is strapped to the maternal&#xD;
      abdomen and positioned in such a way to detect fetal rather than maternal heart rate. There&#xD;
      are occasional periods of signal loss as the patient or her fetus moves, as well as times&#xD;
      when the monitor incorrectly records the maternal signal. Maternal obesity presents&#xD;
      particular challenges to non-invasive monitoring.&#xD;
&#xD;
      When there is particular concern regarding the fetal heart rate tracing the obstetrician may&#xD;
      opt for a fetal scalp electrode (FSE). This is screwed into the fetus' presenting part&#xD;
      through the opening in the cervix (requires ruptured membranes and adequate dilation). This&#xD;
      signal is usually more reliable, but entails risks of chorioamnionitis, fetal scalp&#xD;
      infection, scalp hematoma, and potential vertical transmission of maternal viruses including&#xD;
      HIV and hepatitis.&#xD;
&#xD;
      Recently, devices have come to market that extract the FHR and uterine electromyograph (EMG)&#xD;
      from maternal abdominal electrodes. The proposed study will provide data for refinement of&#xD;
      the LaborView device produced by OBMedical.&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
      The goal of this research is to evaluate the LaborView device under various settings and&#xD;
      fetal heart rate accuracy as compared to a traditional CTG monitor.&#xD;
&#xD;
      Research Plan:&#xD;
&#xD;
      All patients admitted to the Labor &amp; Delivery Suite at UF Health, will be eligible for&#xD;
      inclusion in the study except minors and those unable to consent for themselves.&#xD;
&#xD;
      Following written informed consent, the external monitors (tocodynamometer and ultrasound)&#xD;
      may not be removed. Per LaborView directions, electrode application sites will be prepared to&#xD;
      reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired&#xD;
      for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG&#xD;
      (electrocardiography), and uterine activity data from the existing fetal monitors will be&#xD;
      collected via a laptop PC connected to the systems for comparison. The comparison will be&#xD;
      performed off-line.&#xD;
&#xD;
      Evaluation of the data obtained will include (1) comparison of the calculated FHR with that&#xD;
      of the CTG and/or fetal scalp electrode.&#xD;
&#xD;
      Nothing is required of the subjects. They will be non-invasively monitored for one to several&#xD;
      hours. The information obtained will not be used for medical decision-making and there is no&#xD;
      significant risk to the patient or her fetus. No longitudinal follow-up is planned or&#xD;
      indicated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2016</start_date>
  <completion_date type="Actual">April 11, 2018</completion_date>
  <primary_completion_date type="Actual">April 11, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study</measure>
    <time_frame>1 - 8 hours</time_frame>
    <description>Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Fetal Monitoring</condition>
  <arm_group>
    <arm_group_label>Pregnant Females</arm_group_label>
    <description>All patients admitted to the Labor &amp; Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.&#xD;
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LaborView Electronic Fetal Monitor</intervention_name>
    <description>Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and FHR data acquired for comparison with CTG data obtained through the traditional monitoring system. The comparison will be performed off-line.&#xD;
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus.</description>
    <arm_group_label>Pregnant Females</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant Females admitted to Labor and Delivery at Shands UF Health who are over the age of&#xD;
        18 and able to consent themselves.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to Labor and Delivery at Shands UF Health&#xD;
&#xD;
          -  Are able to consent for themselves&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Under the age of 18&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only Pregnant Females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Florida Shands Health</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>August 20, 2018</results_first_submitted>
  <results_first_submitted_qc>August 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2019</results_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03244865/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03244865/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03244865/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pregnant Females</title>
          <description>All patients admitted to the Labor &amp; Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.&#xD;
Nothing is required of the participants. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.&#xD;
LaborView Electronic Fetal Monitor: Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG, and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pregnant Females</title>
          <description>All patients admitted to the Labor &amp; Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.&#xD;
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.&#xD;
LaborView Electronic Fetal Monitor: Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG, and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="27" spread="30.69"/>
                  </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="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Subjects in active labor</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study</title>
        <description>Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).</description>
        <time_frame>1 - 8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pregnant Females</title>
            <description>There is only one arm in this study. All monitored patients admitted to Labor &amp; Delivery at UF Health, are eligible for inclusion in the study except minors and those unable to consent for themselves. They are non-invasively monitored for 1 to several hours. The information obtained is not used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.&#xD;
All subjects in the study maintain the standard CTG monitoring they are using prior to enrollment in the study. The LaborView Electronic Fetal Monitor is added to the subject and both standard CTG FHR and LaborView FHR are collected simultaneously. LaborView electrode application sites are prepared to reduce skin impedance, and electrodes are applied to the maternal abdomen. The data collection laptop collects data from the standard monitor via serial port of the CTG and from LaborView via USB. The comparison of data is performed off-line.</description>
          </group>
        </group_list>
        <measure>
          <title>Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study</title>
          <description>Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.282" lower_limit="4.8" upper_limit="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>There is only one ARM in the study. Standard monitoring and LaborView monitoring will be collected simultaneously and analyzed.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority will be verified if the RMSE between the two systems is within 7 BPM. A complete power analysis was not included as this is a pilot study.</non_inferiority_desc>
            <p_value>&lt;.1</p_value>
            <p_value_desc>Pilot Study</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>11 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pregnant Females</title>
          <description>All patients admitted to the Labor &amp; Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.&#xD;
LaborView Electronic Fetal Monitor: Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG, and uterine activity data from the existing fetal monitors will be collected via a laptop PC connected to the systems for comparison. The comparison will be performed off-line.&#xD;
Nothing is required of the participants. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus.</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="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
              </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="35"/>
              </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>Dr. Tammy Euliano</name_or_title>
      <organization>UF Health Department of Anesthesiology</organization>
      <phone>352-514-7460</phone>
      <email>teuliano@anest.ufl.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/NCT03244865
org study id: PRO00009835
nct id: NCT03244865
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal
      well-being during labor or preparation for cesarean delivery. Current monitoring methods:
      transabdominal ultrasound (CTG: cardiotocograph) and fetal scalp electrodes (FSE) have
      limitations (tracing loss during fetal movement, potential to confuse maternal for fetal
      heart rate, inability to monitor during cesarean section or abdominal surgery) and, in the
      latter case, risks (infection, hematoma). A reliable, non-invasive monitor of the fetal heart
      rate that can be used during labor, non-obstetric and obstetric surgery during pregnancy is
      needed. Recent developments in use of maternal abdominal electrodes for extraction of the FHR
      and contraction information inform this study.

      LaborView®, developed by researchers at University of Florida (UF) College of Medicine and
      OBMedical, is an FDA-approved non-invasive labor monitoring device. Refinement of the
      extraction algorithms continues, and that work is most effectively performed at UF, where the
      primary researchers and OBMedical are located.

      LaborView monitoring will be recorded from up to150 subjects admitted to Labor and Delivery
      at UFHealth. Data will be simultaneously obtained from the standard labor monitor. These
      signals will then be analyzed off-line for comparison and refinement of algorithms.
Despite its limitations, fetal heart rate (FHR) tracing analysis is the best monitor of fetal
      well being during labor. Typically, continuous electronic fetal monitoring is via
      transabdominal ultrasound (CTG: cardiotocograph). A transducer is strapped to the maternal
      abdomen and positioned in such a way to detect fetal rather than maternal heart rate. There
      are occasional periods of signal loss as the patient or her fetus moves, as well as times
      when the monitor incorrectly records the maternal signal. Maternal obesity presents
      particular challenges to non-invasive monitoring.

      When there is particular concern regarding the fetal heart rate tracing the obstetrician may
      opt for a fetal scalp electrode (FSE). This is screwed into the fetus' presenting part
      through the opening in the cervix (requires ruptured membranes and adequate dilation). This
      signal is usually more reliable, but entails risks of chorioamnionitis, fetal scalp
      infection, scalp hematoma, and potential vertical transmission of maternal viruses including
      HIV and hepatitis.

      Recently, devices have come to market that extract the FHR and uterine electromyograph (EMG)
      from maternal abdominal electrodes. The proposed study will provide data for refinement of
      the LaborView device produced by OBMedical.

      Specific Aims:

      The goal of this research is to evaluate the LaborView device under various settings and
      fetal heart rate accuracy as compared to a traditional CTG monitor.

      Research Plan:

      All patients admitted to the Labor & Delivery Suite at UF Health, will be eligible for
      inclusion in the study except minors and those unable to consent for themselves.

      Following written informed consent, the external monitors (tocodynamometer and ultrasound)
      may not be removed. Per LaborView directions, electrode application sites will be prepared to
      reduce skin impedance, electrodes will be applied to the maternal abdomen and data acquired
      for comparison with CTG data obtained through the traditional monitoring system. FHR, ECG
      (electrocardiography), and uterine activity data from the existing fetal monitors will be
      collected via a laptop PC connected to the systems for comparison. The comparison will be
      performed off-line.

      Evaluation of the data obtained will include (1) comparison of the calculated FHR with that
      of the CTG and/or fetal scalp electrode.

      Nothing is required of the subjects. They will be non-invasively monitored for one to several
      hours. The information obtained will not be used for medical decision-making and there is no
      significant risk to the patient or her fetus. No longitudinal follow-up is planned or
      indicated.
observational model: Other
time perspective: Other
measure: Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study
time frame: 1 - 8 hours
description: Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).
arm group label: Pregnant Females
description: All patients admitted to the Labor & Delivery Suite at UF Health, will be eligible for inclusion in the study except minors and those unable to consent for themselves.
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus. No longitudinal follow-up is planned or indicated.
intervention type: Device
intervention name: LaborView Electronic Fetal Monitor
description: Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and FHR data acquired for comparison with CTG data obtained through the traditional monitoring system. The comparison will be performed off-line.
Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus.
arm group label: Pregnant Females
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only Pregnant Females
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 