<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/NCT02993354</url>
  </required_header>
  <id_info>
    <org_study_id>2015-4881</org_study_id>
    <nct_id>NCT02993354</nct_id>
  </id_info>
  <brief_title>Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device</brief_title>
  <acronym>EUM</acronym>
  <official_title>Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable&#xD;
      as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is&#xD;
      safe and effective in monitoring uterine contractions. The investigators propose to perform a&#xD;
      series of studies to validate the accuracy and clinical usefulness of the EUM device by&#xD;
      simultaneously monitoring patients with current methods (with either external or internal&#xD;
      devices) as clinically indicated and with the EUM device. Providers will be blinded to the&#xD;
      results of the EUM device. The investigators will continue care as per current guidelines&#xD;
      using the information obtained from the current monitoring methods. Information obtained from&#xD;
      the EUM devices will not be used to determine the clinical course of action.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      The investigators propose to perform a study to validate the accuracy and clinical usefulness&#xD;
      of the EUM device by comparing it with simultaneous use of current methods (both external or&#xD;
      internal devices) among obese patients and patients with normal body mass indexes (BMI).&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Compare the contractions obtained using the EUM device vs. those obtained using the&#xD;
           intrauterine pressure catheter vs. those obtained from external tocodynamometer among&#xD;
           current obese patients (BMI greater than 30 kg/m2) and nonobese patients using&#xD;
           simultaneously obtained, 30 minute tracings with regards to the frequency of&#xD;
           contractions, the duration of contractions, maximum height of the contractions, the&#xD;
           total Montevideo units recorded, the timing of the contractions, and the amount of&#xD;
           discontinuous tracings from the devices.&#xD;
&#xD;
        2. Compare the fetal heart rate tracing obtained via the EUM device vs. external fetal&#xD;
           Doppler vs. fetal scalp electrode (simultaneously obtained, 30 minute tracings will be&#xD;
           compared) among obese patients and nonobese patients with regards to the amount of&#xD;
           discontinuous/unterinterpetable tracing, average fetal heart rate, baseline heart rate,&#xD;
           the number accelerations, the number of decelerations, the timing of the accelerations,&#xD;
           the timing of decelerations, the maximum fetal heart rate achieved during acceleration,&#xD;
           the lowest fetal heart rate achieved during deceleration, and compare the degree of&#xD;
           variability in the tracing.&#xD;
&#xD;
        3. Compare tracings of productive vs. non-productive contractions in patients presenting to&#xD;
           triage to rule out labor (30 minutes of simultaneously obtained tracings of external&#xD;
           tocodynamometer and EUM device will be compared) with regards to the frequency of&#xD;
           contractions, the duration of contractions, maximum height of contractions, the timing&#xD;
           of the contractions and the amount of discontinuous tracings from both devices, as well&#xD;
           as changes in cervical exam on the basis of body mass index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB&#xD;
    approval.&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">September 21, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 21, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Contractions</measure>
    <time_frame>30 mins</time_frame>
    <description>1. Compare the contractions obtained using the EUM device vs. those obtained using the intrauterine pressure catheter vs. those obtained from external tocodynamometer among current obese patients (BMI greater than 30 kg/m2) and nonobese patients using simultaneously obtained, 30 minute tracings with regards to the frequency of contractions, the duration of contractions, maximum height of the contractions, the total Montevideo units recorded, the timing of the contractions, and the amount of discontinuous tracings from the devices.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fetal heart rate</measure>
    <time_frame>30 mins</time_frame>
    <description>2. Compare the fetal heart rate tracing obtained via the EUM device vs. external fetal Doppler vs. fetal scalp electrode (simultaneously obtained, 30 minute tracings will be compared) among obese patients and nonobese patients with regards to the amount of discontinuous/unterinterpetable tracing, average fetal heart rate, baseline heart rate, the number accelerations, the number of decelerations, the timing of the accelerations, the timing of decelerations, the maximum fetal heart rate achieved during acceleration, the lowest fetal heart rate achieved during deceleration, and compare the degree of variability in the tracing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Productive Contractions</measure>
    <time_frame>30 mins</time_frame>
    <description>3. Compare tracings of productive vs. non-productive contractions in patients presenting to triage to rule out labor (30 minutes of simultaneously obtained tracings of external tocodynamometer and EUM device will be compared) with regards to the frequency of contractions, the duration of contractions, maximum height of contractions, the timing of the contractions and the amount of discontinuous tracings from both devices, as well as changes in cervical exam on the basis of body mass index.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Fetal Distress</condition>
  <condition>Fetal Monitoring</condition>
  <condition>Contraction</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <description>Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The EUM300 (electrical uterine myography)</intervention_name>
    <description>External monitor intended for the evaluation of electrical signals originating in the uterus, thus providing a tool for measuring uterine activity as well as fetal heart rate.</description>
    <arm_group_label>Pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Maternal age &gt;18 years old&#xD;
&#xD;
          2. Singleton pregnancy&#xD;
&#xD;
          3. Gestational age of 24 completed weeks or greater based on the estimated due date as&#xD;
             calculated from last menstrual period or early ultrasound&#xD;
&#xD;
          4. Category I (reassuring) fetal heart rate tracing at time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Fetal anomaly or chromosome defect&#xD;
&#xD;
          2. Allergy to silver&#xD;
&#xD;
          3. Woman with implanted electronic device of any kind&#xD;
&#xD;
          4. Irritated skin or open wound on the abdominal wall&#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_official>
    <last_name>Peter Bernstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jack D. Weiler Hospital of Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Distress</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 8, 2021</submitted>
    <returned>July 28, 2021</returned>
    <submitted>November 2, 2021</submitted>
    <returned>December 2, 2021</returned>
    <submitted>July 17, 2022</submitted>
    <returned>May 24, 2023</returned>
    <submitted>August 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02993354
org study id: 2015-4881
nct id: NCT02993354
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable
      as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is
      safe and effective in monitoring uterine contractions. The investigators propose to perform a
      series of studies to validate the accuracy and clinical usefulness of the EUM device by
      simultaneously monitoring patients with current methods (with either external or internal
      devices) as clinically indicated and with the EUM device. Providers will be blinded to the
      results of the EUM device. The investigators will continue care as per current guidelines
      using the information obtained from the current monitoring methods. Information obtained from
      the EUM devices will not be used to determine the clinical course of action.
Purpose:

      The investigators propose to perform a study to validate the accuracy and clinical usefulness
      of the EUM device by comparing it with simultaneous use of current methods (both external or
      internal devices) among obese patients and patients with normal body mass indexes (BMI).

      Objectives:

        1. Compare the contractions obtained using the EUM device vs. those obtained using the
           intrauterine pressure catheter vs. those obtained from external tocodynamometer among
           current obese patients (BMI greater than 30 kg/m2) and nonobese patients using
           simultaneously obtained, 30 minute tracings with regards to the frequency of
           contractions, the duration of contractions, maximum height of the contractions, the
           total Montevideo units recorded, the timing of the contractions, and the amount of
           discontinuous tracings from the devices.

        2. Compare the fetal heart rate tracing obtained via the EUM device vs. external fetal
           Doppler vs. fetal scalp electrode (simultaneously obtained, 30 minute tracings will be
           compared) among obese patients and nonobese patients with regards to the amount of
           discontinuous/unterinterpetable tracing, average fetal heart rate, baseline heart rate,
           the number accelerations, the number of decelerations, the timing of the accelerations,
           the timing of decelerations, the maximum fetal heart rate achieved during acceleration,
           the lowest fetal heart rate achieved during deceleration, and compare the degree of
           variability in the tracing.

        3. Compare tracings of productive vs. non-productive contractions in patients presenting to
           triage to rule out labor (30 minutes of simultaneously obtained tracings of external
           tocodynamometer and EUM device will be compared) with regards to the frequency of
           contractions, the duration of contractions, maximum height of contractions, the timing
           of the contractions and the amount of discontinuous tracings from both devices, as well
           as changes in cervical exam on the basis of body mass index.
observational model: Cohort
time perspective: Prospective
measure: Contractions
time frame: 30 mins
description: 1. Compare the contractions obtained using the EUM device vs. those obtained using the intrauterine pressure catheter vs. those obtained from external tocodynamometer among current obese patients (BMI greater than 30 kg/m2) and nonobese patients using simultaneously obtained, 30 minute tracings with regards to the frequency of contractions, the duration of contractions, maximum height of the contractions, the total Montevideo units recorded, the timing of the contractions, and the amount of discontinuous tracings from the devices.
measure: Fetal heart rate
time frame: 30 mins
description: 2. Compare the fetal heart rate tracing obtained via the EUM device vs. external fetal Doppler vs. fetal scalp electrode (simultaneously obtained, 30 minute tracings will be compared) among obese patients and nonobese patients with regards to the amount of discontinuous/unterinterpetable tracing, average fetal heart rate, baseline heart rate, the number accelerations, the number of decelerations, the timing of the accelerations, the timing of decelerations, the maximum fetal heart rate achieved during acceleration, the lowest fetal heart rate achieved during deceleration, and compare the degree of variability in the tracing.
measure: Productive Contractions
time frame: 30 mins
description: 3. Compare tracings of productive vs. non-productive contractions in patients presenting to triage to rule out labor (30 minutes of simultaneously obtained tracings of external tocodynamometer and EUM device will be compared) with regards to the frequency of contractions, the duration of contractions, maximum height of contractions, the timing of the contractions and the amount of discontinuous tracings from both devices, as well as changes in cervical exam on the basis of body mass index.
arm group label: Pregnant women
description: Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks.
intervention type: Device
intervention name: The EUM300 (electrical uterine myography)
description: External monitor intended for the evaluation of electrical signals originating in the uterus, thus providing a tool for measuring uterine activity as well as fetal heart rate.
arm group label: Pregnant women
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: Peter Bernstein, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fetal Distress
submitted: July 8, 2021
returned: July 28, 2021
submitted: November 2, 2021
returned: December 2, 2021
submitted: July 17, 2022
returned: May 24, 2023
submitted: August 9, 2023