<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/NCT04447248</url>
  </required_header>
  <id_info>
    <org_study_id>QDSP Protocol</org_study_id>
    <nct_id>NCT04447248</nct_id>
  </id_info>
  <brief_title>qCTG and Doppler Ultrasound in the Detection of Hypoxia Among FGR Fetuses</brief_title>
  <official_title>Quantitative Cardiotocography and Doppler Ultrasound in the Detection of Hypoxia Among Growth-restricted Fetuses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthogyn Medical Center, Bulgaria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orthogyn Medical Center, Bulgaria</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>
      To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels&#xD;
      with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of&#xD;
      fetal hypoxia (pH &lt; 7.20) among late-onset growth restricted (SGR) fetuses&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2011</start_date>
  <completion_date type="Actual">October 7, 2019</completion_date>
  <primary_completion_date type="Actual">October 7, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurence of hypoxia (pH&lt;7.20) at birth</measure>
    <time_frame>up to 5 minutes after delivery</time_frame>
  </primary_outcome>
  <enrollment type="Actual">1714</enrollment>
  <condition>Late-onset Fetal Growth Restriction</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>QDSP Protocol</intervention_name>
    <description>Computerized expert system for fetal monitoring, based on cardiotocogrpaphy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Bulgarian population (caucasian)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  estimated fetal weight below the 10th centile of the reference curve for the Bulgarian&#xD;
             population (11);&#xD;
&#xD;
          -  absence of sonographic and laboratory evidence of structural anomalies;&#xD;
&#xD;
          -  absence of severe maternal complications;&#xD;
&#xD;
          -  documented birth weight &lt; 10th centile;&#xD;
&#xD;
          -  full follow-up documentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple pregnancies;&#xD;
&#xD;
          -  congenital malformations and any chromosomal malformations known before labor and&#xD;
             delivery;&#xD;
&#xD;
          -  severe maternal complications;&#xD;
&#xD;
          -  documented birth weight &gt; 10th centile;&#xD;
&#xD;
          -  pregnancy loss;&#xD;
&#xD;
          -  failure to obtain full follow-up documentation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Orthogyn Medical Center, Bulgaria</investigator_affiliation>
    <investigator_full_name>Petar Ignatov</investigator_full_name>
    <investigator_title>Assist. Prof. Petar Ignatov, MD, Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04447248
org study id: QDSP Protocol
nct id: NCT04447248
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels
      with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of
      fetal hypoxia (pH < 7.20) among late-onset growth restricted (SGR) fetuses
observational model: Case-Only
time perspective: Retrospective
measure: Occurence of hypoxia (pH<7.20) at birth
time frame: up to 5 minutes after delivery
intervention type: Device
intervention name: QDSP Protocol
description: Computerized expert system for fetal monitoring, based on cardiotocogrpaphy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Orthogyn Medical Center, Bulgaria
investigator full name: Petar Ignatov
investigator title: Assist. Prof. Petar Ignatov, MD, Ph.D.
mesh term: Fetal Growth Retardation
mesh term: Hypoxia
sharing ipd: Undecided