<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/NCT04438668</url>
  </required_header>
  <id_info>
    <org_study_id>2019-01</org_study_id>
    <nct_id>NCT04438668</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Performance of Centaflow</brief_title>
  <official_title>Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centaflow</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Viborg Regional Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centaflow</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to evaluate the safety and performance of an acoustic approach based&#xD;
      on skin-contact microphones as a routine assessment of placental vascular function as&#xD;
      predictor of fetal growth restriction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of the safety and performance of Centaflow as routine antenatal assessment of&#xD;
      placental vascular function as predictor of fetal growth restriction is performed by&#xD;
      randomizing singleton pregnant women with ultrasound-based gestations for either standard&#xD;
      care (SC) or SC and Centaflow (CF).&#xD;
&#xD;
      The subjects will be randomized in ratio 1:1 in both groups and examined in pregnancy weeks&#xD;
      27-29, 34-36 and 37-39.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>
    <intervention_model_description>Randomised Controlled Trial</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fetal Growth Restriction (FGR)</measure>
    <time_frame>At birth</time_frame>
    <description>Outcome is the classification of each neonate as FGR or as non-FGR at birth. FGR is defined as birth weight below the 3rd percentile or birth weight below the 10th percentile and an antenatally detected abnormal umbilical artery blood flow.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: occurrence of device-related adverse events</measure>
    <time_frame>At gestational week 27-29</time_frame>
    <description>Outcome is the occurrence of device-related adverse events and their classification as serious or not.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: occurrence of device-related adverse events</measure>
    <time_frame>At gestational week 34-36</time_frame>
    <description>Outcome is the occurrence of device-related adverse events and their classification as serious or not.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: occurrence of device-related adverse events</measure>
    <time_frame>At gestational week 37-39</time_frame>
    <description>Outcome is the occurrence of device-related adverse events and their classification as serious or not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>At birth</time_frame>
    <description>Outcome is the mode of delivery being either A) uncomplicated vaginal, B) complicated vaginal, C) planned cesarean section or D) emergency cesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Intensive Care Unit</measure>
    <time_frame>At 12 days postpartum</time_frame>
    <description>Outcome is the occurrence of admission to the Neonatal Intensive Care Unit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1704</enrollment>
  <condition>Fetal Growth Restriction</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care (SC) for screening for FGR is a healthcare provider auscultating the foetal heart rate with a standard stethoscope, palpation of foetal size by hand, and measuring the size of the woman's uterus with a tape measure, and comparing the measurement to the expected measurement for the gestational age of the foetus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care and Centaflow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Centaflow uses sound-derived maternal intra-arterial turbulence as a marker of foetal growth restriction (FGR) and provides information on the foetal heart rate. Indication for use is as a screening device for FGR in women beyond 27 weeks of pregnancy with a singleton pregnancy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Centaflow and Standard Care</intervention_name>
    <description>The intervention is screening methods</description>
    <arm_group_label>Standard Care and Centaflow</arm_group_label>
    <other_name>Standard Care is Symphysis-fundal measure and fetal weight estimation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>The intervention is screening methods</description>
    <arm_group_label>Standard Care</arm_group_label>
    <other_name>Symphysis-fundal measure and fetal weight estimation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Female subjects over the age of 18 years.&#xD;
&#xD;
          -  Subejct is pregnant, carries only one fetus and has been pregnancy dated by ultrasound&#xD;
             scan (Hadlock reference).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days&#xD;
             postnatally.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Farlie, MD, MI, MHM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Viborg Regional Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard Farlie, MD, MI, MHM</last_name>
    <phone>+45 78 44 58 63</phone>
    <email>richard.farlie@midt.rm.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olav Bjoern Petersen, Professor, MD</last_name>
    <phone>+45 35 45 09 08</phone>
    <email>olav.bennike.bjoern.petersen@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Juliane Marie Centeret, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olav Petersen, Professor</last_name>
      <phone>+45 35 45 09 08</phone>
      <email>olav.bennike.bjoern.petersen@regionh.dk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Obstetrical Department, Regional Hospital Viborg</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Farlie, MD</last_name>
      <phone>+45 78445863</phone>
      <email>richard.farlie@midt.rm.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</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 Growth Retardation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.</ipd_description>
  </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/NCT04438668
org study id: 2019-01
nct id: NCT04438668
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the safety and performance of an acoustic approach based
      on skin-contact microphones as a routine assessment of placental vascular function as
      predictor of fetal growth restriction.
Evaluation of the safety and performance of Centaflow as routine antenatal assessment of
      placental vascular function as predictor of fetal growth restriction is performed by
      randomizing singleton pregnant women with ultrasound-based gestations for either standard
      care (SC) or SC and Centaflow (CF).

      The subjects will be randomized in ratio 1:1 in both groups and examined in pregnancy weeks
      27-29, 34-36 and 37-39.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised Controlled Trial
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fetal Growth Restriction (FGR)
time frame: At birth
description: Outcome is the classification of each neonate as FGR or as non-FGR at birth. FGR is defined as birth weight below the 3rd percentile or birth weight below the 10th percentile and an antenatally detected abnormal umbilical artery blood flow.
measure: Safety: occurrence of device-related adverse events
time frame: At gestational week 27-29
description: Outcome is the occurrence of device-related adverse events and their classification as serious or not.
measure: Safety: occurrence of device-related adverse events
time frame: At gestational week 34-36
description: Outcome is the occurrence of device-related adverse events and their classification as serious or not.
measure: Safety: occurrence of device-related adverse events
time frame: At gestational week 37-39
description: Outcome is the occurrence of device-related adverse events and their classification as serious or not.
measure: Mode of delivery
time frame: At birth
description: Outcome is the mode of delivery being either A) uncomplicated vaginal, B) complicated vaginal, C) planned cesarean section or D) emergency cesarean section.
measure: Neonatal Intensive Care Unit
time frame: At 12 days postpartum
description: Outcome is the occurrence of admission to the Neonatal Intensive Care Unit
arm group label: Standard Care
arm group type: Active Comparator
description: Standard care (SC) for screening for FGR is a healthcare provider auscultating the foetal heart rate with a standard stethoscope, palpation of foetal size by hand, and measuring the size of the woman's uterus with a tape measure, and comparing the measurement to the expected measurement for the gestational age of the foetus.
arm group label: Standard Care and Centaflow
arm group type: Experimental
description: Centaflow uses sound-derived maternal intra-arterial turbulence as a marker of foetal growth restriction (FGR) and provides information on the foetal heart rate. Indication for use is as a screening device for FGR in women beyond 27 weeks of pregnancy with a singleton pregnancy.
intervention type: Device
intervention name: Centaflow and Standard Care
description: The intervention is screening methods
arm group label: Standard Care and Centaflow
other name: Standard Care is Symphysis-fundal measure and fetal weight estimation
intervention type: Diagnostic Test
intervention name: Standard Care
description: The intervention is screening methods
arm group label: Standard Care
other name: Symphysis-fundal measure and fetal weight estimation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Farlie, MD, MI, MHM
role: Principal Investigator
affiliation: Viborg Regional Hospital
last name: Richard Farlie, MD, MI, MHM
phone: +45 78 44 58 63
email: richard.farlie@midt.rm.dk
last name: Olav Bjoern Petersen, Professor, MD
phone: +45 35 45 09 08
email: olav.bennike.bjoern.petersen@regionh.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Fetal Growth Retardation
sharing ipd: No
ipd description: Sharing raw data is inconsistent with the ethics application form and the participant informed consent materials.