<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/NCT02229630</url>
  </required_header>
  <id_info>
    <org_study_id>P130915</org_study_id>
    <secondary_id>IDRCB: 2014-A00640-47</secondary_id>
    <nct_id>NCT02229630</nct_id>
  </id_info>
  <brief_title>Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.</brief_title>
  <acronym>REDIFF</acronym>
  <official_title>Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the apparent diffusion coefficient in the frontal&#xD;
      lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared&#xD;
      with foetuses with intra-uterine growth restriction and a good neonatal outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intra-uterine growth restriction is associated with an increased risk of perinatal&#xD;
      morbimortality. The objective of foetal monitoring is to assess foetal growth, foetal&#xD;
      well-being and to evaluate ability to adapt to chronic hypoxia.&#xD;
&#xD;
      The primary objective in antenatal care is to ischemic cerebral lesions. However, there is&#xD;
      currently no relevant prenatal exam predictive for the risk of such lesions.&#xD;
&#xD;
      Foetal cerebral MRI could highlight changes in Apparent Diffusion Coefficient (ADC) in some&#xD;
      frontal cerebral territories in foetuses with intra-uterine growth restriction and poor&#xD;
      neonatal outcome.&#xD;
&#xD;
      These changes could be associated with a transient cerebral ischemia. The study of ADC could&#xD;
      be a useful tool in the prognostic evaluation of these foetuses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2015</start_date>
  <completion_date type="Actual">October 17, 2019</completion_date>
  <primary_completion_date type="Actual">October 29, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Poor neonatal status</measure>
    <time_frame>At birth</time_frame>
    <description>Neonatal death; Apgar score &lt; 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH &lt; 7.10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Poor neonatal status</measure>
    <time_frame>until 30 days of life</time_frame>
    <description>Necrositing enterocolitis with need for surgical intervention; convulsions; intraventricular haemorrhage (type I to IV); periventricular leukomalacia (diagnosed by MRI); transfer to neonatal intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal status at neonatology unit discharge</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>Neurological status: normal / abnormal; need in O2: Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological development</measure>
    <time_frame>At 2 years of age (adjusted age)</time_frame>
    <description>Age and stages questionnaire (ASQ)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Pregnant Women With Foetuses Presenting With Intra-uterine Growth Restriction</condition>
  <arm_group>
    <arm_group_label>Pregnant women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight &lt; 5th percentile (Hadlock calculator)</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Pregnant women with intra-uterine growth restricted Foetuses</intervention_name>
    <description>Diffusion-weighted cerebral MRI before 32 weeks of gestation</description>
    <arm_group_label>Pregnant women</arm_group_label>
    <other_name>cerebral MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  single pregnancy&#xD;
&#xD;
          -  estimated foetal weight ≤ 5th percentile&#xD;
&#xD;
          -  agreeing to participate&#xD;
&#xD;
          -  women age ≥ 18 years of age, speaking and understanding French language&#xD;
&#xD;
          -  covered by the French social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  foetal malformation or foetal karyotype abnormal&#xD;
&#xD;
          -  infectious foetopathy&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  refusal to participate&#xD;
&#xD;
          -  pregnant women aged &lt; 18 years old&#xD;
&#xD;
          -  pregnant women not understanding or speaking French language&#xD;
&#xD;
          -  not covered by French social security&#xD;
&#xD;
          -  contraindication to MRI&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marie Jouannic, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Armand Trousseau</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20. doi: 10.1016/S0140-6736(04)16809-8.</citation>
    <PMID>15302194</PMID>
  </reference>
  <reference>
    <citation>Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA; DIGITAT study group. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010 Dec 21;341:c7087. doi: 10.1136/bmj.c7087.</citation>
    <PMID>21177352</PMID>
  </reference>
  <reference>
    <citation>Boyer AC, Goncalves LF, Lee W, Shetty A, Holman A, Yeo L, Romero R. Magnetic resonance diffusion-weighted imaging: reproducibility of regional apparent diffusion coefficients for the normal fetal brain. Ultrasound Obstet Gynecol. 2013 Feb;41(2):190-7. doi: 10.1002/uog.11219. Epub 2013 Jan 3.</citation>
    <PMID>22744761</PMID>
  </reference>
  <results_reference>
    <citation>Jouannic JM, Blondiaux E, Senat MV, Friszer S, Adamsbaum C, Rousseau J, Hornoy P, Letourneau A, de Laveaucoupet J, Lecarpentier E, Rosenblatt J, Quibel T, Mollot M, Ancel PY, Alison M, Goffinet F. Prognostic value of diffusion-weighted magnetic resonance imaging of brain in fetal growth restriction: results of prospective multicenter study. Ultrasound Obstet Gynecol. 2020 Dec;56(6):893-900. doi: 10.1002/uog.21926.</citation>
    <PMID>31765031</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>April 2, 2021</last_update_submitted>
  <last_update_submitted_qc>April 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intra-uterine growth restriction</keyword>
  <keyword>MRI</keyword>
  <keyword>apparent diffusion coefficient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</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/NCT02229630
org study id: P130915
secondary id: IDRCB: 2014-A00640-47
nct id: NCT02229630
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the apparent diffusion coefficient in the frontal
      lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared
      with foetuses with intra-uterine growth restriction and a good neonatal outcome.
Intra-uterine growth restriction is associated with an increased risk of perinatal
      morbimortality. The objective of foetal monitoring is to assess foetal growth, foetal
      well-being and to evaluate ability to adapt to chronic hypoxia.

      The primary objective in antenatal care is to ischemic cerebral lesions. However, there is
      currently no relevant prenatal exam predictive for the risk of such lesions.

      Foetal cerebral MRI could highlight changes in Apparent Diffusion Coefficient (ADC) in some
      frontal cerebral territories in foetuses with intra-uterine growth restriction and poor
      neonatal outcome.

      These changes could be associated with a transient cerebral ischemia. The study of ADC could
      be a useful tool in the prognostic evaluation of these foetuses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Poor neonatal status
time frame: At birth
description: Neonatal death; Apgar score < 7 at 5 min, immediate transfer to neonatal resuscitation unit; cordon arterial pH < 7.10
measure: Poor neonatal status
time frame: until 30 days of life
description: Necrositing enterocolitis with need for surgical intervention; convulsions; intraventricular haemorrhage (type I to IV); periventricular leukomalacia (diagnosed by MRI); transfer to neonatal intensive care unit
measure: Neonatal status at neonatology unit discharge
time frame: up to 20 weeks
description: Neurological status: normal / abnormal; need in O2: Yes/No
measure: Neurological development
time frame: At 2 years of age (adjusted age)
description: Age and stages questionnaire (ASQ)
arm group label: Pregnant women
arm group type: Experimental
description: Foetuses with intra-uterine growth restriction, between 28 and 32 weeks of gestation, with an estimated foetal weight < 5th percentile (Hadlock calculator)
intervention type: Radiation
intervention name: Pregnant women with intra-uterine growth restricted Foetuses
description: Diffusion-weighted cerebral MRI before 32 weeks of gestation
arm group label: Pregnant women
other name: cerebral MRI
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marie Jouannic, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20. doi: 10.1016/S0140-6736(04)16809-8.
PMID: 15302194
citation: Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA; DIGITAT study group. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010 Dec 21;341:c7087. doi: 10.1136/bmj.c7087.
PMID: 21177352
citation: Boyer AC, Goncalves LF, Lee W, Shetty A, Holman A, Yeo L, Romero R. Magnetic resonance diffusion-weighted imaging: reproducibility of regional apparent diffusion coefficients for the normal fetal brain. Ultrasound Obstet Gynecol. 2013 Feb;41(2):190-7. doi: 10.1002/uog.11219. Epub 2013 Jan 3.
PMID: 22744761
citation: Jouannic JM, Blondiaux E, Senat MV, Friszer S, Adamsbaum C, Rousseau J, Hornoy P, Letourneau A, de Laveaucoupet J, Lecarpentier E, Rosenblatt J, Quibel T, Mollot M, Ancel PY, Alison M, Goffinet F. Prognostic value of diffusion-weighted magnetic resonance imaging of brain in fetal growth restriction: results of prospective multicenter study. Ultrasound Obstet Gynecol. 2020 Dec;56(6):893-900. doi: 10.1002/uog.21926.
PMID: 31765031
responsible party type: Sponsor
mesh term: Fetal Growth Retardation