xml: <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/NCT06031142</url>
    </required_header>
    <id_info>
      <org_study_id>PROFE23186I</org_study_id>
      <secondary_id>2022YFB4400800</secondary_id>
      <nct_id>NCT06031142</nct_id>
    </id_info>
    <brief_title>A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy</brief_title>
    <acronym>AHTSWFEADP</acronym>
    <official_title>Flexible Wearable Device for Continuous Fetal Heart Rate and Movement Monitoring.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</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>
        The goal of this observational is to compare in describing fetal health conditions. The main&#xD;
        questions it aims to answer are:&#xD;
  &#xD;
          -  fetal electrocardiogram (fetal heart rate and fetal rhythm)&#xD;
  &#xD;
          -  electrohysterography (uterine contractions).&#xD;
  &#xD;
        Participants will wear wearable devices and CTG equipment for monitoring for 30 minutes.If&#xD;
        there is a comparison group: Researchers will compare clinical CTG equipment to see if this&#xD;
        wearable device.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators put the patch of the wearable device on the abdomen of the pregnant woman&#xD;
        and continued the test for thirty minutes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 29, 2023</start_date>
    <completion_date type="Actual">August 6, 2023</completion_date>
    <primary_completion_date type="Actual">July 29, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Family-Based</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>4 Weeks</target_duration>
    <primary_outcome>
      <measure>The performance of this system in extracting fetal electrocardiogram (FECG)</measure>
      <time_frame>2022.01-2023.08</time_frame>
      <description>extract fetal QRS intervals and numbers from FECG</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The performance of this system in extracting electrohysterography (EHG)</measure>
      <time_frame>2022.01-2023.08</time_frame>
      <description>use the contractions consistency index (CCI) parameters to analyze the relation between our measured EHG signal and the UC signal recorded by clinical CTG equipment.</description>
    </primary_outcome>
    <enrollment type="Actual">4</enrollment>
    <condition>Uterine Contractions; Prolonged</condition>
    <condition>Fetal Heart Rate or Rhythm Abnormality Affecting Fetus</condition>
    <condition>Pregnancy Related</condition>
    <condition>Home Range</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>use wearable devices to monitoring fetal health conditions.</intervention_name>
      <description>We used wearable devices and clinical cardiotocography (CTG) equipment to monitor pregnant women for 30 minutes to demonstrate the reliability of wearable devices.</description>
      <other_name>Non-invasive monitoring</other_name>
      <other_name>FECG</other_name>
      <other_name>EHG</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A wearable and remote fetal monitoring system is specifically developed for home use. It&#xD;
          aims to overcome the limitations of conventional cardiotocography (CTG) devices by&#xD;
          providing great user comfort and long-term continuous monitoring.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women with a gestational cycle greater than 36 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  male&#xD;
  &#xD;
            -  Pregnant women with a gestational cycle less than 36 weeks&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tingting Li, master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>FetaCare</name>
        <address>
          <city>Shanghai</city>
          <state>Pudong New District， Shanghai</state>
          <zip>200100</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Hao Li</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>FECG</keyword>
    <keyword>EHG</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Congenital Abnormalities</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031142
  org study id: PROFE23186I
  secondary id: 2022YFB4400800
  nct id: NCT06031142
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational is to compare in describing fetal health conditions. The main
        questions it aims to answer are:
  
          -  fetal electrocardiogram (fetal heart rate and fetal rhythm)
  
          -  electrohysterography (uterine contractions).
  
        Participants will wear wearable devices and CTG equipment for monitoring for 30 minutes.If
        there is a comparison group: Researchers will compare clinical CTG equipment to see if this
        wearable device.
  The investigators put the patch of the wearable device on the abdomen of the pregnant woman
        and continued the test for thirty minutes.
  observational model: Family-Based
  time perspective: Prospective
  measure: The performance of this system in extracting fetal electrocardiogram (FECG)
  time frame: 2022.01-2023.08
  description: extract fetal QRS intervals and numbers from FECG
  measure: The performance of this system in extracting electrohysterography (EHG)
  time frame: 2022.01-2023.08
  description: use the contractions consistency index (CCI) parameters to analyze the relation between our measured EHG signal and the UC signal recorded by clinical CTG equipment.
  intervention type: Device
  intervention name: use wearable devices to monitoring fetal health conditions.
  description: We used wearable devices and clinical cardiotocography (CTG) equipment to monitor pregnant women for 30 minutes to demonstrate the reliability of wearable devices.
  other name: Non-invasive monitoring
  other name: FECG
  other name: EHG
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tingting Li, master
  role: Principal Investigator
  affiliation: Fudan University
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Hao Li
  investigator title: Principal Investigator
  mesh term: Congenital Abnormalities
  sharing ipd: No