<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/NCT03838965</url>
  </required_header>
  <id_info>
    <org_study_id>0101-18-HYMC</org_study_id>
    <nct_id>NCT03838965</nct_id>
  </id_info>
  <brief_title>The Effects of Labor Stages and Interventions on Hemodynamic Measures During &amp; After Childbirth With Noninvasive Sensors</brief_title>
  <official_title>The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth (Epidural, Rupture of Membranes, Cesarean Sections and Preeclampsia) With Noninvasive Sensors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</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 Effects of Labor Stages and Interventions on Hemodynamic Measures During and After&#xD;
      Childbirth ( Epidural, Rupture Membranses Cesarean Sections and Preeclampsia) With&#xD;
      Noninvasive Sensors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">December 16, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth</measure>
    <time_frame>24 hours</time_frame>
    <description>biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth</measure>
    <time_frame>24 hours</time_frame>
    <description>biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Rupture of Membranes; Premature</condition>
  <condition>Cesarean Section; Infection</condition>
  <condition>Preeclampsia</condition>
  <arm_group>
    <arm_group_label>biobeat sensor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>biobeat sensor</intervention_name>
    <description>biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth and after 24 hours.</description>
    <arm_group_label>biobeat sensor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman between 18-45 years old&#xD;
&#xD;
          -  with non cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  woman with a cardiovascular disease&#xD;
&#xD;
          -  woman who don't agree to participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuval Atsmon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>3810101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>June 22, 2022</last_update_submitted>
  <last_update_submitted_qc>June 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 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>Pre-Eclampsia</mesh_term>
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03838965
org study id: 0101-18-HYMC
nct id: NCT03838965
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After
      Childbirth ( Epidural, Rupture Membranses Cesarean Sections and Preeclampsia) With
      Noninvasive Sensors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth
time frame: 24 hours
description: biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth
measure: biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth
time frame: 24 hours
description: biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth
arm group label: biobeat sensor
arm group type: Experimental
intervention type: Device
intervention name: biobeat sensor
description: biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth and after 24 hours.
arm group label: biobeat sensor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuval Atsmon, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Pre-Eclampsia
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture
sharing ipd: No