<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/NCT04429178</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00774; qu19Buddeberg</org_study_id>
    <nct_id>NCT04429178</nct_id>
  </id_info>
  <brief_title>Portal Vein Pulsatility Flow in Pregnancy</brief_title>
  <official_title>Portal Vein Pulsatility Flow in Pregnancy - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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 study is to investigate if portal vein pulsatility fraction can be measured in pregnancy&#xD;
      and if it increases during the course of pregnancy as would be expected by the physiologic&#xD;
      increase in blood volume that happens during pregnancy. Portal vein pulsatility fraction is&#xD;
      measured in non-pregnant controls and in women in the 1st, 2nd and 3rd trimester of&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>Portal vein pulsatility fraction (percent)</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Portal vein pulsatility fraction (percent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inferior vena cava diameter (mm)</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Inferior vena cava diameter (mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inferior vena cava collapsibility index (percent)</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Inferior vena cava collapsibility index (percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic venous flow (cm/sec)</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Hepatic venous flow (cm/sec)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right atrial and ventricular dimensions (cm)</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Right atrial and ventricular dimensions (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>women in the 1st trimester of pregnancy.</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>women in the 2nd trimester of pregnancy.</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>women in the 3rd trimester of pregnancy.</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>non-pregnant women</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <description>portal vein pulsatility fraction (percent) measured with ultrasound</description>
    <arm_group_label>non-pregnant women</arm_group_label>
    <arm_group_label>women in the 1st trimester of pregnancy.</arm_group_label>
    <arm_group_label>women in the 2nd trimester of pregnancy.</arm_group_label>
    <arm_group_label>women in the 3rd trimester of pregnancy.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women attending either the anaesthetic preassessment clinic or the obstetric&#xD;
        ultrasound clinic at University Hospital Basel.&#xD;
&#xD;
        Non-pregnant healthy females fulfilling the inclusion criteria will be recruited by&#xD;
        published advertisement at the University Hospital Basel.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Class I and II&#xD;
&#xD;
          -  Singleton pregnancy during 1st, 2nd or 3rd trimester or healthy non-pregnant females&#xD;
             of childbearing age as controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Significant co-morbidities (e.g. cardiac abnormalities, cardiac dysfunction,&#xD;
             arrhythmias, severe asthma, renal insufficiency)&#xD;
&#xD;
          -  High risk pregnancies (e.g. pre-eclampsia, gestational hypertension, HELLP,&#xD;
             gestational diabetes)&#xD;
&#xD;
          -  Body-Mass-Index (BMI) &lt; 18kg/m2 or &gt;40kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bigna Buddeberg, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>portal vein pulsatility</keyword>
  <keyword>physiologic volume overload</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/NCT04429178
org study id: 2020-00774; qu19Buddeberg
nct id: NCT04429178
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to investigate if portal vein pulsatility fraction can be measured in pregnancy
      and if it increases during the course of pregnancy as would be expected by the physiologic
      increase in blood volume that happens during pregnancy. Portal vein pulsatility fraction is
      measured in non-pregnant controls and in women in the 1st, 2nd and 3rd trimester of
      pregnancy.
observational model: Cohort
time perspective: Prospective
measure: Portal vein pulsatility fraction (percent)
time frame: single time-point at baseline
description: Portal vein pulsatility fraction (percent)
measure: Inferior vena cava diameter (mm)
time frame: single time-point at baseline
description: Inferior vena cava diameter (mm)
measure: Inferior vena cava collapsibility index (percent)
time frame: single time-point at baseline
description: Inferior vena cava collapsibility index (percent)
measure: Hepatic venous flow (cm/sec)
time frame: single time-point at baseline
description: Hepatic venous flow (cm/sec)
measure: Right atrial and ventricular dimensions (cm)
time frame: single time-point at baseline
description: Right atrial and ventricular dimensions (cm)
measure: Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
time frame: single time-point at baseline
description: Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
arm group label: women in the 1st trimester of pregnancy.
arm group label: women in the 2nd trimester of pregnancy.
arm group label: women in the 3rd trimester of pregnancy.
arm group label: non-pregnant women
intervention type: Other
intervention name: ultrasound
description: portal vein pulsatility fraction (percent) measured with ultrasound
arm group label: non-pregnant women
arm group label: women in the 1st trimester of pregnancy.
arm group label: women in the 2nd trimester of pregnancy.
arm group label: women in the 3rd trimester of pregnancy.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bigna Buddeberg, Dr. med.
role: Principal Investigator
affiliation: Department of Anesthesiology, University Hospital Basel
facility: 
country: Switzerland
responsible party type: Sponsor