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/NCT06021925</url>
    </required_header>
    <id_info>
      <org_study_id>APHP221333</org_study_id>
      <secondary_id>2021-A01199-32</secondary_id>
      <nct_id>NCT06021925</nct_id>
    </id_info>
    <brief_title>Obstetrical History and Anti-HLA Antibodies Level</brief_title>
    <acronym>OBS-HLA</acronym>
    <official_title>Obstetrical History and Anti-HLA Antibodies Level</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Etablissement Français du Sang (Nouvelle Aquitaine)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        Chronic histiocytic intervillositis (CHI) is associated with severe and recurrent obstetrical&#xD;
        complications. A link between anti-HLA Antibodies (Ab) and CHI has recently been established.&#xD;
        At the Etablissement Français du Sang (EFS), donors who have already given birth once and&#xD;
        have high levels of anti-HLA are excluded from donating apheresis platelets and therapeutic&#xD;
        plasma to prevent TRALI (Transfusion Related Acute Lung Injury). No studies have examined the&#xD;
        obstetrical history of these donors. The question is: is there an association between&#xD;
        anti-HLA levels and obstetrical complications?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of around 5&#xD;
        in 10,000 pregnancies. It is defined by major infiltration of the intervillous cavity by&#xD;
        CD68+ maternal histiocytes, associated with fibrin deposition on the villous surface.&#xD;
  &#xD;
        CHI is associated with severe obstetrical complications and a very high recurrence rate,&#xD;
        estimated at between 70% and 100%. These complications include early and late miscarriage,&#xD;
        fetal death, severe growth retardation in surviving fetuses, and premature delivery. The&#xD;
        survival rate reported in the literature varies between 30% and 50%.&#xD;
  &#xD;
        Anti-HLA antibodies are present in 54% of pregnant women at the end of pregnancy, and their&#xD;
        rate increases towards the end of pregnancy. The presence of HLA antibodies also increases&#xD;
        with the number of pregnancies, and is found in up to 74% of cases after more than 2&#xD;
        deliveries.&#xD;
  &#xD;
        The research question concerns the existence of a statistically significant association&#xD;
        between the presence of high levels of anti-HLA antibodies and the occurrence of one or more&#xD;
        obstetric complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>To measure the association between the occurrence of obstetrical complications and the level of anti-HLA Ab measured during the screening test performed by the EFS.</measure>
      <time_frame>2 months</time_frame>
      <description>Obstetrical complications are defined as (binomial qualitative variable) :&#xD;
  Preterm delivery &lt; 37 WA&#xD;
  Fetal death in utero whatever the term&#xD;
  Early or late miscarriage&#xD;
  Early or late pre-eclampsia&#xD;
  Medical termination of pregnancy&#xD;
  Intrauterine growth retardation &lt;3rd percentile</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Type and precocity of obstetrical complication (multinomial qualitative variable)</measure>
      <time_frame>2 months</time_frame>
      <description>Preterm deliveries &lt; 37 WA and ≥ 34 WA&#xD;
  Premature deliveries &lt; 34 WA&#xD;
  Fetal death in utero regardless of term&#xD;
  Late miscarriage &lt; 22 WA and ≥ 14 WA&#xD;
  Early miscarriage &lt; 14 WA&#xD;
  Late pre-eclampsia &gt; 37 WA and ≥ 34 WA&#xD;
  Early pre-eclampsia &lt; 34 WA&#xD;
  Medical termination of pregnancy&#xD;
  Intrauterine growth retardation &lt;3rd percentile</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measure the association between the type and precocity of obstetrical complications according to the type of anti-HLA Ab (class I and/or class II), when these Ab are found during the screening test performed by the EFS</measure>
      <time_frame>2 months</time_frame>
      <description>Preterm deliveries &lt; 37 WA and ≥ 34 WA&#xD;
  Premature deliveries &lt; 34 WA&#xD;
  Fetal death in utero regardless of term&#xD;
  Late miscarriage &lt; 22 WA and ≥ 14 WA&#xD;
  Early miscarriage &lt; 14 WA&#xD;
  Late pre-eclampsia &gt; 37 WA and ≥ 34 WA&#xD;
  Early pre-eclampsia &lt; 34 WA&#xD;
  Medical termination of pregnancy&#xD;
  Intrauterine growth retardation &lt;3rd percentile</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Verify the absence of response bias by comparing the HLA Ab levels of responding versus non-responding donors.</measure>
      <time_frame>2 months</time_frame>
      <description>Anti-HLA antibody rate (median)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">6000</enrollment>
    <condition>Blood Donors</condition>
    <condition>Anti-HLA Antibody</condition>
    <arm_group>
      <arm_group_label>Blood donors tested for anti-HLA Antibody</arm_group_label>
      <description>Blood donors tested for anti-HLA Antibody between 2010 and 2020 as part of TRALI prevention program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Obstetrical history</intervention_name>
      <description>Selection of donors by EFS retrospectively on the basis of inclusion criteria. Information note sent by e-mail, non-opposition as well as a questionnaire to be completed online to obtain data on obstetrical history.</description>
      <arm_group_label>Blood donors tested for anti-HLA Antibody</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Anti-HLA Antibody tests</intervention_name>
      <description>Analyze responses in relation to the results of the anti-HLA Antibody tests performed at the time of donation.</description>
      <arm_group_label>Blood donors tested for anti-HLA Antibody</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Blood donors who were screened for anti-HLA Ab between 2010 and 2020 as part of TRALI&#xD;
          prevention at the EFS Poitiers site histocompatibility laboratory.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female blood donors who have been tested for anti-HLA antibodies in the context of&#xD;
               TRALI prevention between 2010 and 2020 at EFS Nouvelle Aquitaine [The donors meet the&#xD;
               conditions of the Order of December 17, 2019 establishing the selection criteria for&#xD;
               blood donors and are over 18 years old, are not protected persons and understand&#xD;
               French well]&#xD;
  &#xD;
            -  Women who have already given birth at least once (non-nulliparous women)&#xD;
  &#xD;
            -  Women who have not expressed their opposition at the time of donation to participating&#xD;
               in a research project and to be contacted&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None [Donors meet the conditions of the Order of December 17, 2019 establishing the&#xD;
               selection criteria for blood donors and are over 18 years old, are not protected&#xD;
               persons and understand French well]&#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>
    <overall_official>
      <last_name>Xavier LAFARGE, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Etablissement Français du Sang (Nouvelle Aquitaine)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alexandra BENACHI, Professor</last_name>
      <role>Study Director</role>
      <affiliation>APHP, Antoine Béclère Hospital, CLAMART, France</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xavier LAFARGE, Doctor</last_name>
      <phone>05 56 90 83 93</phone>
      <email>xavier.lafarge@efs.sante.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Isabelle JOLLET</last_name>
      <phone>05 49 61 57 27</phone>
      <email>isabelle.jollet@efs.sante.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Etablissement Français du Sang Nouvelle Aquitaine</name>
        <address>
          <city>Bordeaux</city>
          <zip>33075</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Xavier LAFARGE</last_name>
        <phone>05 56 90 83 93</phone>
        <email>xavier.lafarge@efs.sante.fr</email>
      </contact>
      <contact_backup>
        <last_name>Isabelle JOLLET</last_name>
        <phone>05 49 61 57 27</phone>
        <email>isabelle.jollet@efs.sante.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Obstetrical complications</keyword>
    <keyword>Levels of anti-HLA antibody</keyword>
    <keyword>Chronic histiocytic intervillositis</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06021925
  org study id: APHP221333
  secondary id: 2021-A01199-32
  nct id: NCT06021925
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic histiocytic intervillositis (CHI) is associated with severe and recurrent obstetrical
        complications. A link between anti-HLA Antibodies (Ab) and CHI has recently been established.
        At the Etablissement Français du Sang (EFS), donors who have already given birth once and
        have high levels of anti-HLA are excluded from donating apheresis platelets and therapeutic
        plasma to prevent TRALI (Transfusion Related Acute Lung Injury). No studies have examined the
        obstetrical history of these donors. The question is: is there an association between
        anti-HLA levels and obstetrical complications?
  Chronic histiocytic intervillositis (CHI) is a rare condition with an incidence of around 5
        in 10,000 pregnancies. It is defined by major infiltration of the intervillous cavity by
        CD68+ maternal histiocytes, associated with fibrin deposition on the villous surface.
  
        CHI is associated with severe obstetrical complications and a very high recurrence rate,
        estimated at between 70% and 100%. These complications include early and late miscarriage,
        fetal death, severe growth retardation in surviving fetuses, and premature delivery. The
        survival rate reported in the literature varies between 30% and 50%.
  
        Anti-HLA antibodies are present in 54% of pregnant women at the end of pregnancy, and their
        rate increases towards the end of pregnancy. The presence of HLA antibodies also increases
        with the number of pregnancies, and is found in up to 74% of cases after more than 2
        deliveries.
  
        The research question concerns the existence of a statistically significant association
        between the presence of high levels of anti-HLA antibodies and the occurrence of one or more
        obstetric complications.
  observational model: Cohort
  time perspective: Prospective
  measure: To measure the association between the occurrence of obstetrical complications and the level of anti-HLA Ab measured during the screening test performed by the EFS.
  time frame: 2 months
  description: Obstetrical complications are defined as (binomial qualitative variable) :
  Preterm delivery < 37 WA
  Fetal death in utero whatever the term
  Early or late miscarriage
  Early or late pre-eclampsia
  Medical termination of pregnancy
  Intrauterine growth retardation <3rd percentile
  measure: Type and precocity of obstetrical complication (multinomial qualitative variable)
  time frame: 2 months
  description: Preterm deliveries < 37 WA and ≥ 34 WA
  Premature deliveries < 34 WA
  Fetal death in utero regardless of term
  Late miscarriage < 22 WA and ≥ 14 WA
  Early miscarriage < 14 WA
  Late pre-eclampsia > 37 WA and ≥ 34 WA
  Early pre-eclampsia < 34 WA
  Medical termination of pregnancy
  Intrauterine growth retardation <3rd percentile
  measure: Measure the association between the type and precocity of obstetrical complications according to the type of anti-HLA Ab (class I and/or class II), when these Ab are found during the screening test performed by the EFS
  time frame: 2 months
  description: Preterm deliveries < 37 WA and ≥ 34 WA
  Premature deliveries < 34 WA
  Fetal death in utero regardless of term
  Late miscarriage < 22 WA and ≥ 14 WA
  Early miscarriage < 14 WA
  Late pre-eclampsia > 37 WA and ≥ 34 WA
  Early pre-eclampsia < 34 WA
  Medical termination of pregnancy
  Intrauterine growth retardation <3rd percentile
  measure: Verify the absence of response bias by comparing the HLA Ab levels of responding versus non-responding donors.
  time frame: 2 months
  description: Anti-HLA antibody rate (median)
  arm group label: Blood donors tested for anti-HLA Antibody
  description: Blood donors tested for anti-HLA Antibody between 2010 and 2020 as part of TRALI prevention program.
  intervention type: Other
  intervention name: Obstetrical history
  description: Selection of donors by EFS retrospectively on the basis of inclusion criteria. Information note sent by e-mail, non-opposition as well as a questionnaire to be completed online to obtain data on obstetrical history.
  arm group label: Blood donors tested for anti-HLA Antibody
  intervention type: Other
  intervention name: Anti-HLA Antibody tests
  description: Analyze responses in relation to the results of the anti-HLA Antibody tests performed at the time of donation.
  arm group label: Blood donors tested for anti-HLA Antibody
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xavier LAFARGE, Doctor
  role: Principal Investigator
  affiliation: Etablissement Français du Sang (Nouvelle Aquitaine)
  last name: Alexandra BENACHI, Professor
  role: Study Director
  affiliation: APHP, Antoine Béclère Hospital, CLAMART, France
  last name: Xavier LAFARGE, Doctor
  phone: 05 56 90 83 93
  email: xavier.lafarge@efs.sante.fr
  last name: Isabelle JOLLET
  phone: 05 49 61 57 27
  email: isabelle.jollet@efs.sante.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Antibodies
  sharing ipd: No