<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/NCT03013569</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003276</org_study_id>
    <nct_id>NCT03013569</nct_id>
  </id_info>
  <brief_title>Spontaneous Fetal EEG Recording During Labor</brief_title>
  <official_title>Can Spontaneous Fetal EEG Be Recorded During Labor Using the Established Fetal Scalp Electrode Heart Rate Monitoring System?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot feasibility study for a new application of an approved fetal heart rate&#xD;
      monitoring device system. The objective of this study is to validate the feasibility of&#xD;
      acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the&#xD;
      routinely used scalp fetal heart rate (FHR) monitor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators' objective is to validate the feasibility of acquiring the new modality of&#xD;
      human fetal bioelectrical activity, EEG, derived from the routinely used scalp FHR monitor.&#xD;
&#xD;
      The investigators expect that in some newborns acidemia will be detected based on cord blood&#xD;
      pH. In these babies, the investigators will trace back the EEG recordings to further validate&#xD;
      whether the EEG - FHR patterns were predictive of this outcome. In fetal sheep model of human&#xD;
      labour the investigators were able to see the onset of acidemia &lt;55 min ahead of severe drop&#xD;
      of pH to &lt;7.00. This corresponded to an average pH of 7.20.&#xD;
&#xD;
      The investigators hypothesize that they will be able to acquire fetal EEG during labour such&#xD;
      that the normal behavioural sleep states will be observed and their disruption, followed by&#xD;
      emergence of the pathognomonic EEG-FHR pattern will be seen with incipient acidemia.&#xD;
&#xD;
      At-risk pregnant women routinely admitted for intrapartum monitoring will be asked to consent&#xD;
      when the Fetal Scalp Monitor (FSM) is placed. The attachment will be such that no direct&#xD;
      contact to mother or baby will be established and hence no current from device to the mother&#xD;
      or the baby will be possible. The EEG fetal health monitoring device is attached to the&#xD;
      routinely used fetal heart rate (FHR) GE HC Corometrix 250cx monitor. The EEG recording will&#xD;
      commence only once the FSM is attached; the attachment of the FSM will be performed based on&#xD;
      medical necessity, not based on the need to record EEG.&#xD;
&#xD;
      Duration of recording will be dependent on the labour duration. However, the investigators&#xD;
      will seek for a minimum of 30 minutes and continue as long as medically possible per subject.&#xD;
&#xD;
      Fetal EEG will be analyzed as published. The quickest reference to the analytical approach is&#xD;
      given here: http://dx.doi.org/10.1371/journal.pone.0108119.g001&#xD;
&#xD;
      Cord blood gas at delivery will be recorded from electronic medical record, as it is taken&#xD;
      routinely at birth. Basic maternal and neonatal clinical characteristics (BMI, APGAR scores,&#xD;
      number of pregnancies and live births, maternal and fetal ages at birth), will also be taken&#xD;
      from the medical record.&#xD;
&#xD;
      b. Experience and preliminary work. Briefly describe experience or preliminary work or data&#xD;
      (if any) that you or your team have that supports the feasibility and/or safety of this&#xD;
      study. Nine years of research and development to show that fetal EEG measurements can predict&#xD;
      the level of acidemia at birth. Safety testing performed on site successfully for recording&#xD;
      fetal EEG during labor as described.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recording spontaneous EEG during labor</measure>
    <time_frame>12 month recruitment period</time_frame>
    <description>The investigators will record spontaneous fetal EEG activity during labor using a custom-build IRB-approved fetal EEG device. The validity of the recorded data will be analyzed based on the physiological characteristics of the data such as amplitude and frequency properties as well as the behavioral state architecture (duration of low voltage/high frequency and high voltage/low frequency states as well as of the indeterminate states). The data will be analyzed in conjunction with the accompanying fetal heart rate recordings which also show behavioral state fluctuations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fetal acidemia</measure>
    <time_frame>12 month recruitment period</time_frame>
    <description>EEG recordings will be used to validate whether the EEG-FHR patterns are predictive of fetal acidemia intrapartum</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pregnancy Abnormal</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women of reproductive age in labor at term&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women in labor, with medical complications of pregnancy, such as IUGR, hypertension,&#xD;
        diabetes, or obesity (BMI over 30).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Maternal or fetal infection or bleeding disorder;&#xD;
&#xD;
          2. Birth through Caesarian section will only be excluded if decided a priori;&#xD;
&#xD;
          3. Non-English speaking.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin G Frasch, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin G Frasch, MD, PhD</last_name>
    <phone>206-543-5892</phone>
    <email>mfrasch@uw.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amy Gest, MPA</last_name>
    <phone>206-359-1961</phone>
    <email>agest@uw.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin G Frasch, MD, PhD</last_name>
      <phone>206-543-5892</phone>
      <email>mfrasch@uw.edu</email>
    </contact>
    <contact_backup>
      <last_name>Amy Gest, MPA</last_name>
      <phone>206-359-1961</phone>
      <email>agest@uw.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://FraschLab.org</url>
    <description>The website of the laboratory of Dr. Frasch, the PI on the study</description>
  </link>
  <reference>
    <citation>Wang X, Durosier LD, Ross MG, Richardson BS, Frasch MG. Online detection of fetal acidemia during labour by testing synchronization of EEG and heart rate: a prospective study in fetal sheep. PLoS One. 2014 Sep 30;9(9):e108119. doi: 10.1371/journal.pone.0108119. eCollection 2014.</citation>
    <PMID>25268842</PMID>
  </reference>
  <reference>
    <citation>Frasch MG, Durosier LD, Gold N, Cao M, Matushewski B, Keenliside L, Louzoun Y, Ross MG, Richardson BS. Adaptive shut-down of EEG activity predicts critical acidemia in the near-term ovine fetus. Physiol Rep. 2015 Jul;3(7):e12435. doi: 10.14814/phy2.12435.</citation>
    <PMID>26149280</PMID>
  </reference>
  <reference>
    <citation>Xu A, Durosier LD, Ross MG, Hammond R, Richardson BS, Frasch MG. Adaptive brain shut-down counteracts neuroinflammation in the near-term ovine fetus. Front Neurol. 2014 Jun 30;5:110. doi: 10.3389/fneur.2014.00110. eCollection 2014.</citation>
    <PMID>25071698</PMID>
  </reference>
  <reference>
    <citation>Frasch MG, Keen AE, Gagnon R, Ross MG, Richardson BS. Monitoring fetal electrocortical activity during labour for predicting worsening acidemia: a prospective study in the ovine fetus near term. PLoS One. 2011;6(7):e22100. doi: 10.1371/journal.pone.0022100. Epub 2011 Jul 15.</citation>
    <PMID>21789218</PMID>
  </reference>
  <results_reference>
    <citation>Castel A, Frank YS, Feltner J, Karp FB, Albright CM, Frasch MG. Monitoring Fetal Electroencephalogram Intrapartum: A Systematic Literature Review. Front Pediatr. 2020 Sep 11;8:584. doi: 10.3389/fped.2020.00584. eCollection 2020.</citation>
    <PMID>33042922</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Martin Frasch</investigator_full_name>
    <investigator_title>Research Assistant Professor, Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03013569
org study id: STUDY00003276
nct id: NCT03013569
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot feasibility study for a new application of an approved fetal heart rate
      monitoring device system. The objective of this study is to validate the feasibility of
      acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the
      routinely used scalp fetal heart rate (FHR) monitor.
The investigators' objective is to validate the feasibility of acquiring the new modality of
      human fetal bioelectrical activity, EEG, derived from the routinely used scalp FHR monitor.

      The investigators expect that in some newborns acidemia will be detected based on cord blood
      pH. In these babies, the investigators will trace back the EEG recordings to further validate
      whether the EEG - FHR patterns were predictive of this outcome. In fetal sheep model of human
      labour the investigators were able to see the onset of acidemia <55 min ahead of severe drop
      of pH to <7.00. This corresponded to an average pH of 7.20.

      The investigators hypothesize that they will be able to acquire fetal EEG during labour such
      that the normal behavioural sleep states will be observed and their disruption, followed by
      emergence of the pathognomonic EEG-FHR pattern will be seen with incipient acidemia.

      At-risk pregnant women routinely admitted for intrapartum monitoring will be asked to consent
      when the Fetal Scalp Monitor (FSM) is placed. The attachment will be such that no direct
      contact to mother or baby will be established and hence no current from device to the mother
      or the baby will be possible. The EEG fetal health monitoring device is attached to the
      routinely used fetal heart rate (FHR) GE HC Corometrix 250cx monitor. The EEG recording will
      commence only once the FSM is attached; the attachment of the FSM will be performed based on
      medical necessity, not based on the need to record EEG.

      Duration of recording will be dependent on the labour duration. However, the investigators
      will seek for a minimum of 30 minutes and continue as long as medically possible per subject.

      Fetal EEG will be analyzed as published. The quickest reference to the analytical approach is
      given here: http://dx.doi.org/10.1371/journal.pone.0108119.g001

      Cord blood gas at delivery will be recorded from electronic medical record, as it is taken
      routinely at birth. Basic maternal and neonatal clinical characteristics (BMI, APGAR scores,
      number of pregnancies and live births, maternal and fetal ages at birth), will also be taken
      from the medical record.

      b. Experience and preliminary work. Briefly describe experience or preliminary work or data
      (if any) that you or your team have that supports the feasibility and/or safety of this
      study. Nine years of research and development to show that fetal EEG measurements can predict
      the level of acidemia at birth. Safety testing performed on site successfully for recording
      fetal EEG during labor as described.
observational model: Case-Only
time perspective: Prospective
measure: Recording spontaneous EEG during labor
time frame: 12 month recruitment period
description: The investigators will record spontaneous fetal EEG activity during labor using a custom-build IRB-approved fetal EEG device. The validity of the recorded data will be analyzed based on the physiological characteristics of the data such as amplitude and frequency properties as well as the behavioral state architecture (duration of low voltage/high frequency and high voltage/low frequency states as well as of the indeterminate states). The data will be analyzed in conjunction with the accompanying fetal heart rate recordings which also show behavioral state fluctuations.
measure: Fetal acidemia
time frame: 12 month recruitment period
description: EEG recordings will be used to validate whether the EEG-FHR patterns are predictive of fetal acidemia intrapartum
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Martin G Frasch, MD, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Martin G Frasch, MD, PhD
phone: 206-543-5892
email: mfrasch@uw.edu
last name: Amy Gest, MPA
phone: 206-359-1961
email: agest@uw.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: https://FraschLab.org
description: The website of the laboratory of Dr. Frasch, the PI on the study
citation: Wang X, Durosier LD, Ross MG, Richardson BS, Frasch MG. Online detection of fetal acidemia during labour by testing synchronization of EEG and heart rate: a prospective study in fetal sheep. PLoS One. 2014 Sep 30;9(9):e108119. doi: 10.1371/journal.pone.0108119. eCollection 2014.
PMID: 25268842
citation: Frasch MG, Durosier LD, Gold N, Cao M, Matushewski B, Keenliside L, Louzoun Y, Ross MG, Richardson BS. Adaptive shut-down of EEG activity predicts critical acidemia in the near-term ovine fetus. Physiol Rep. 2015 Jul;3(7):e12435. doi: 10.14814/phy2.12435.
PMID: 26149280
citation: Xu A, Durosier LD, Ross MG, Hammond R, Richardson BS, Frasch MG. Adaptive brain shut-down counteracts neuroinflammation in the near-term ovine fetus. Front Neurol. 2014 Jun 30;5:110. doi: 10.3389/fneur.2014.00110. eCollection 2014.
PMID: 25071698
citation: Frasch MG, Keen AE, Gagnon R, Ross MG, Richardson BS. Monitoring fetal electrocortical activity during labour for predicting worsening acidemia: a prospective study in the ovine fetus near term. PLoS One. 2011;6(7):e22100. doi: 10.1371/journal.pone.0022100. Epub 2011 Jul 15.
PMID: 21789218
citation: Castel A, Frank YS, Feltner J, Karp FB, Albright CM, Frasch MG. Monitoring Fetal Electroencephalogram Intrapartum: A Systematic Literature Review. Front Pediatr. 2020 Sep 11;8:584. doi: 10.3389/fped.2020.00584. eCollection 2020.
PMID: 33042922
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Martin Frasch
investigator title: Research Assistant Professor, Obstetrics and Gynecology
sharing ipd: Undecided