<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/NCT01681498</url>
  </required_header>
  <id_info>
    <org_study_id>12-010</org_study_id>
    <nct_id>NCT01681498</nct_id>
  </id_info>
  <brief_title>Fetal Electrocardiogram Extraction-Pilot Study</brief_title>
  <official_title>Fetal Electrocardiogram Extraction-Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huntleigh Healthcare Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huntleigh Healthcare Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the&#xD;
      feasibility of extracting fECGs in a volunteer population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Indeterminate performance during the first half of the trial.&#xD;
  </why_stopped>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>Beat-to-beat fetal heart rate will be compared to the Doppler result.</measure>
    <time_frame>2 years</time_frame>
    <description>Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the presence of other fECG intervals.</measure>
    <time_frame>2 years</time_frame>
    <description>The fECG Separation Algorithm used in this research incorporates the filtering of noise of very high level as compared with the signal to be retrieved , in combination with employment of SVD (Singular Value Decomposition) methods.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pregnancy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Prenatal care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be pregnant women at least 18 years of age.&#xD;
&#xD;
          -  Subject's fetus must be between the gestational ages of 16 weeks and term.&#xD;
&#xD;
          -  Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG&#xD;
             and Doppler ultrasounds will be performed) in the supine position.&#xD;
&#xD;
          -  Subjects are willing to provide informed consent and are willing to participate in all&#xD;
             procedures necessary to complete the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects must not have a physical or mental condition, in the opinion of the&#xD;
             investigator, which will limit their ability to provide adequate consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menachem H. Graupe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wheaton Franciscan Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wheaton Franciscan, Inc. - St. Joseph</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnant</keyword>
  <keyword>fetal ecg</keyword>
  <keyword>ecg</keyword>
  <!-- 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/NCT01681498
org study id: 12-010
nct id: NCT01681498
lead sponsor: 
has dmc: No
This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the
      feasibility of extracting fECGs in a volunteer population.
observational model: Cohort
time perspective: Prospective
measure: Beat-to-beat fetal heart rate will be compared to the Doppler result.
time frame: 2 years
description: Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy.
measure: Evaluate the presence of other fECG intervals.
time frame: 2 years
description: The fECG Separation Algorithm used in this research incorporates the filtering of noise of very high level as compared with the signal to be retrieved , in combination with employment of SVD (Singular Value Decomposition) methods.
arm group label: Pregnancy
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: Menachem H. Graupe, MD
role: Principal Investigator
affiliation: Wheaton Franciscan Healthcare
facility: 
country: United States
responsible party type: Sponsor