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/NCT06036550</url>
    </required_header>
    <id_info>
      <org_study_id>uterine artery doppler</org_study_id>
      <nct_id>NCT06036550</nct_id>
    </id_info>
    <brief_title>Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.</brief_title>
    <official_title>Inter- and Intra-observer Variability in First-trimester Uterine Artery Doppler Measurements.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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 aim of this study is to investigate the inter- and intra-observer variability of&#xD;
        first-trimester Uterine Artery Doppler ultrasound measurements in pregnancies between 11+0&#xD;
        and 13+0 weeks of gestation. Participants will undergo a measurement protocol (six sets of&#xD;
        Doppler ultrasounds measurements of right and left uterine artery) performed alternately by&#xD;
        two observers (sonographers or physicians who perform these ultrasounds frequently in&#xD;
        clinical practice at the outpatient clinic).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Doppler ultrasound measurements are increasingly performed in clinical practice to detect&#xD;
        high-risk pregnancies. First-trimester uterine artery Doppler measurement might be a&#xD;
        potential predictor for the development of maternal hypertensive disorders later on in&#xD;
        pregnancy. However, before implementing this measurement into clinical practice and&#xD;
        prediction models, the test characteristics of this first-trimester Doppler measurements&#xD;
        should be adequately studied. The objective is to assess the inter- and intra-observer&#xD;
        variability of first-trimester uterine Doppler ultrasound measurements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 11, 2021</start_date>
    <completion_date type="Actual">April 6, 2022</completion_date>
    <primary_completion_date type="Actual">April 6, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Inter- and intra-observer variability of first-trimester Uterine artery Doppler ultrasound</measure>
      <time_frame>Between 11 and 13 weeks of gestation. Measurements will take place during general appointments and will take an extra 2-3 minutes</time_frame>
      <description>The aim of this study is to investigate the inter- and intra-observer variability of first-trimester Uterine Artery Doppler ultrasound measurements, according to the TRUST-study criteria for reproducibility assessment and analysis.</description>
    </primary_outcome>
    <enrollment type="Actual">58</enrollment>
    <condition>Doppler Measurement of Uterine Artery</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Doppler ultrasound measurement</intervention_name>
      <description>Doppler sonographic assessment of the uterine artery was performed transabdominally. Patients underwent six sets of Doppler ultrasounds measurements of both right and left uterine artery.</description>
      <other_name>Philips Ultrasound Inc. Bothell, WA, USA</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All women with a first-trimester singleton pregnancy receiving a Doppler ultrasound at the&#xD;
          outpatient clinic are eligible.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Singleton pregnancy&#xD;
  &#xD;
            -  Gestational age from 11+0 weeks to 13+6 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Maternal age &lt;18 years&#xD;
  &#xD;
                 -  Inability to give informed consent&#xD;
  &#xD;
                 -  Multiple pregnancy&#xD;
  &#xD;
                 -  Abnormal fetal heart tracings&#xD;
  &#xD;
                 -  Non-viable pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Amsterdam University Medical Center</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1105AZ</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <reference>
      <citation>Coelho Neto MA, Roncato P, Nastri CO, Martins WP. True Reproducibility of UltraSound Techniques (TRUST): systematic review of reliability studies in obstetrics and gynecology. Ultrasound Obstet Gynecol. 2015 Jul;46(1):14-20. doi: 10.1002/uog.14654. Epub 2015 Jun 4.</citation>
      <PMID>25175693</PMID>
    </reference>
    <reference>
      <citation>Khalil A, Nicolaides KH. How to record uterine artery Doppler in the first trimester. Ultrasound Obstet Gynecol. 2013 Oct;42(4):478-9. doi: 10.1002/uog.12366. Epub 2013 May 8. No abstract available.</citation>
      <PMID>23658028</PMID>
    </reference>
    <results_reference>
      <citation>Marchi L, Zwertbroek E, Snelder J, Kloosterman M, Bilardo CM. Intra- and inter-observer reproducibility and generalizability of first trimester uterine artery pulsatility index by transabdominal and transvaginal ultrasound. Prenat Diagn. 2016 Dec;36(13):1261-1269. doi: 10.1002/pd.4970. Epub 2016 Dec 6.</citation>
      <PMID>27862084</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Wessel Ganzevoort</investigator_full_name>
      <investigator_title>MD, PhD, Associate Professor, Gynaecologist-Perinatologist</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06036550
  org study id: uterine artery doppler
  nct id: NCT06036550
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate the inter- and intra-observer variability of
        first-trimester Uterine Artery Doppler ultrasound measurements in pregnancies between 11+0
        and 13+0 weeks of gestation. Participants will undergo a measurement protocol (six sets of
        Doppler ultrasounds measurements of right and left uterine artery) performed alternately by
        two observers (sonographers or physicians who perform these ultrasounds frequently in
        clinical practice at the outpatient clinic).
  Doppler ultrasound measurements are increasingly performed in clinical practice to detect
        high-risk pregnancies. First-trimester uterine artery Doppler measurement might be a
        potential predictor for the development of maternal hypertensive disorders later on in
        pregnancy. However, before implementing this measurement into clinical practice and
        prediction models, the test characteristics of this first-trimester Doppler measurements
        should be adequately studied. The objective is to assess the inter- and intra-observer
        variability of first-trimester uterine Doppler ultrasound measurements.
  observational model: Cohort
  time perspective: Prospective
  measure: Inter- and intra-observer variability of first-trimester Uterine artery Doppler ultrasound
  time frame: Between 11 and 13 weeks of gestation. Measurements will take place during general appointments and will take an extra 2-3 minutes
  description: The aim of this study is to investigate the inter- and intra-observer variability of first-trimester Uterine Artery Doppler ultrasound measurements, according to the TRUST-study criteria for reproducibility assessment and analysis.
  intervention type: Diagnostic Test
  intervention name: Doppler ultrasound measurement
  description: Doppler sonographic assessment of the uterine artery was performed transabdominally. Patients underwent six sets of Doppler ultrasounds measurements of both right and left uterine artery.
  other name: Philips Ultrasound Inc. Bothell, WA, USA
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Netherlands
  citation: Coelho Neto MA, Roncato P, Nastri CO, Martins WP. True Reproducibility of UltraSound Techniques (TRUST): systematic review of reliability studies in obstetrics and gynecology. Ultrasound Obstet Gynecol. 2015 Jul;46(1):14-20. doi: 10.1002/uog.14654. Epub 2015 Jun 4.
  PMID: 25175693
  citation: Khalil A, Nicolaides KH. How to record uterine artery Doppler in the first trimester. Ultrasound Obstet Gynecol. 2013 Oct;42(4):478-9. doi: 10.1002/uog.12366. Epub 2013 May 8. No abstract available.
  PMID: 23658028
  citation: Marchi L, Zwertbroek E, Snelder J, Kloosterman M, Bilardo CM. Intra- and inter-observer reproducibility and generalizability of first trimester uterine artery pulsatility index by transabdominal and transvaginal ultrasound. Prenat Diagn. 2016 Dec;36(13):1261-1269. doi: 10.1002/pd.4970. Epub 2016 Dec 6.
  PMID: 27862084
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Wessel Ganzevoort
  investigator title: MD, PhD, Associate Professor, Gynaecologist-Perinatologist
  sharing ipd: Undecided