<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/NCT02196363</url>
  </required_header>
  <id_info>
    <org_study_id>10/H1013/9</org_study_id>
    <nct_id>NCT02196363</nct_id>
  </id_info>
  <brief_title>New Ultrasound Parameters for Predicting Birthweight</brief_title>
  <acronym>NUPS</acronym>
  <official_title>New Ultrasound Parameters for Predicting Birthweight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Babies that are either very small or very big have increased perinatal morbidity and&#xD;
      mortality. Predicting which babies will fall into these groups is traditionally done with&#xD;
      risk assessment and third trimester manual palpation, however neither of these techniques are&#xD;
      sensitive and a considerable number of affected pregnancies are missed. This results in&#xD;
      stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third&#xD;
      trimester can improve detection rates but this is expensive and cannot currently be provided&#xD;
      to all NHS patients.&#xD;
&#xD;
      A more sensitive test that can be performed earlier in pregnancy would allow identification&#xD;
      of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound&#xD;
      techniques that measure volume and volumetric flow have become available that may allow this&#xD;
      to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant&#xD;
      women. The findings from these scans will then be correlated with actual birth weights at the&#xD;
      end of pregnancy to determine the ability of these parameters to act as screening tools for&#xD;
      babies at the extremes of size.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Kidney volume, thigh volume, placental volume, brain volume, final birthweight</measure>
    <time_frame>up to 34-36 weeks pregnancy gestation</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">253</enrollment>
  <condition>Fetal Development</condition>
  <arm_group>
    <arm_group_label>Pregnant mothers</arm_group_label>
    <description>No intervention</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be identified by screening booked scan appointments in regular antenatal&#xD;
        clinics. The first approach will be by either the named local investigators&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women the beginning of pregnancy to term&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancies in women previously affected by unclassfied fetal abnormality&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ed Johnstone, MBChB PhD MRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>CMFT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</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>Birth Weight</mesh_term>
  </condition_browse>
  <!-- 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/NCT02196363
org study id: 10/H1013/9
nct id: NCT02196363
lead sponsor: 
has dmc: No
Babies that are either very small or very big have increased perinatal morbidity and
      mortality. Predicting which babies will fall into these groups is traditionally done with
      risk assessment and third trimester manual palpation, however neither of these techniques are
      sensitive and a considerable number of affected pregnancies are missed. This results in
      stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third
      trimester can improve detection rates but this is expensive and cannot currently be provided
      to all NHS patients.

      A more sensitive test that can be performed earlier in pregnancy would allow identification
      of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound
      techniques that measure volume and volumetric flow have become available that may allow this
      to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant
      women. The findings from these scans will then be correlated with actual birth weights at the
      end of pregnancy to determine the ability of these parameters to act as screening tools for
      babies at the extremes of size.
observational model: Cohort
time perspective: Prospective
measure: Kidney volume, thigh volume, placental volume, brain volume, final birthweight
time frame: up to 34-36 weeks pregnancy gestation
arm group label: Pregnant mothers
description: No intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ed Johnstone, MBChB PhD MRCOG
role: Principal Investigator
affiliation: CMFT
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Birth Weight