<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/NCT02968017</url>
  </required_header>
  <id_info>
    <org_study_id>3571-16-SMC</org_study_id>
    <nct_id>NCT02968017</nct_id>
  </id_info>
  <brief_title>Middle Cerebral Artery Doppler in Uncomplicated Term Pregnancy</brief_title>
  <official_title>Variability in Middle Cerebral Artery Doppler Measurements in Uncomplicated Term Pregnancies.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Doppler measurements in the Middle Cerebral Artery (MCA) is a part of the assessment for&#xD;
      assessing fetal well-being in complicated pregnancy, including Intra Uterine Growth&#xD;
      Retardation and Fetal Anemia.&#xD;
&#xD;
      The use of this Doppler measurement in uncomplicated term pregnancies is not a common&#xD;
      practice due to lack of information. However, several studies use the MCA Pulsatility Index&#xD;
      (PI) as part of the Cerebro-Placental-Ratio (CPR) measurment at term.&#xD;
&#xD;
      The purpose of this trial is to assess MCA Doppler variability in term, uncomplicated&#xD;
      pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Measuring the resistance in the fetal middle cerebral artery (MCA) is an important factor in&#xD;
      assessing fetal well-being. On its own, the Pulsatility Index (PI) in the MCA may indicate a&#xD;
      decrease in fetal oxygenation. Furthermore, the PI measured in the Fetal MCA is an index&#xD;
      parameter in the calculation of the Cerebro-Placental Ratio (CPR) used to evaluate whether&#xD;
      there is an existing disturbance in the Placental-Umbilical and Feto-cerebral circulations.&#xD;
      The CPR is a measurement that enables practitioners to predict the fetuses reaction to&#xD;
      intrauterine hypoxemia. The CPR measurement is commonly used to evaluate small for&#xD;
      gestational age (SGA) fetuses and to distinguish between constitutionally small fetuses and&#xD;
      ones that suffer from placental insufficiency. For those who suffer from placental&#xD;
      insufficiency, the CPR measurement is an aid in deciding the optimal time and mode of&#xD;
      delivery.&#xD;
&#xD;
      Recently, researchers pondered if the CPR measurement may aid in predicting disturbance in&#xD;
      fetal oxygenation during delivery. A number of studies have showed that appropriate for&#xD;
      gestational age fetuses with abnormal CPR measurements may be susceptible to delivery&#xD;
      complications in the same manner as fetuses who suffer from placental insufficiency. The&#xD;
      question that is yet to be answered is whether the MCA measurement reliable in term&#xD;
      pregnancies. This question arises due to the impression that the MCA measurement at term is&#xD;
      highly variable, even when taken under optimal conditions.&#xD;
&#xD;
      The aim of this study is to evaluate the intra-observer variability in the MCA measurement&#xD;
      under optimal conditions, in Uncomplicated Term Pregnancies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2016</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>Pulsatility index (Doppler measurements) in the middle cerebral artery</measure>
    <time_frame>Full Term Pregnancies (37 to 42 weeks)</time_frame>
    <description>Measurement MCA-PI Doppler</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Post Date</condition>
  <arm_group>
    <arm_group_label>MCA-PI</arm_group_label>
    <description>Measurement Middle cerebral artery pulsatility index</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Uncomplicated singleton pregnancies at 37-42 weeks.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Uncomplicated Term Pregnancies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        High Risk Pregnancies including placental insufficiency, intrauterine growth retardation or&#xD;
        any maternal vascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boaz Weisz, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Boaz Weisz, MD</last_name>
    <phone>+ 972 3 5302169</phone>
    <email>Boaz.Weisz@sheba.health.gov.il</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Boaz.Weisz</investigator_full_name>
    <investigator_title>Professor of Fetal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy, Prolonged</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/NCT02968017
org study id: 3571-16-SMC
nct id: NCT02968017
lead sponsor: 
has dmc: No
Doppler measurements in the Middle Cerebral Artery (MCA) is a part of the assessment for
      assessing fetal well-being in complicated pregnancy, including Intra Uterine Growth
      Retardation and Fetal Anemia.

      The use of this Doppler measurement in uncomplicated term pregnancies is not a common
      practice due to lack of information. However, several studies use the MCA Pulsatility Index
      (PI) as part of the Cerebro-Placental-Ratio (CPR) measurment at term.

      The purpose of this trial is to assess MCA Doppler variability in term, uncomplicated
      pregnancy.
Measuring the resistance in the fetal middle cerebral artery (MCA) is an important factor in
      assessing fetal well-being. On its own, the Pulsatility Index (PI) in the MCA may indicate a
      decrease in fetal oxygenation. Furthermore, the PI measured in the Fetal MCA is an index
      parameter in the calculation of the Cerebro-Placental Ratio (CPR) used to evaluate whether
      there is an existing disturbance in the Placental-Umbilical and Feto-cerebral circulations.
      The CPR is a measurement that enables practitioners to predict the fetuses reaction to
      intrauterine hypoxemia. The CPR measurement is commonly used to evaluate small for
      gestational age (SGA) fetuses and to distinguish between constitutionally small fetuses and
      ones that suffer from placental insufficiency. For those who suffer from placental
      insufficiency, the CPR measurement is an aid in deciding the optimal time and mode of
      delivery.

      Recently, researchers pondered if the CPR measurement may aid in predicting disturbance in
      fetal oxygenation during delivery. A number of studies have showed that appropriate for
      gestational age fetuses with abnormal CPR measurements may be susceptible to delivery
      complications in the same manner as fetuses who suffer from placental insufficiency. The
      question that is yet to be answered is whether the MCA measurement reliable in term
      pregnancies. This question arises due to the impression that the MCA measurement at term is
      highly variable, even when taken under optimal conditions.

      The aim of this study is to evaluate the intra-observer variability in the MCA measurement
      under optimal conditions, in Uncomplicated Term Pregnancies.
observational model: Cohort
time perspective: Prospective
measure: Pulsatility index (Doppler measurements) in the middle cerebral artery
time frame: Full Term Pregnancies (37 to 42 weeks)
description: Measurement MCA-PI Doppler
arm group label: MCA-PI
description: Measurement Middle cerebral artery pulsatility index
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boaz Weisz, Prof
role: Principal Investigator
affiliation: Sheba Medical Center
last name: Boaz Weisz, MD
phone: + 972 3 5302169
email: Boaz.Weisz@sheba.health.gov.il
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Boaz.Weisz
investigator title: Professor of Fetal Medicine
mesh term: Pregnancy, Prolonged
sharing ipd: Undecided