<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/NCT03795857</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0371</org_study_id>
    <nct_id>NCT03795857</nct_id>
  </id_info>
  <brief_title>Antenatal Palliative Care</brief_title>
  <acronym>SPAN</acronym>
  <official_title>Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      In France, according to current legislation, termination of pregnancy could be performed&#xD;
      without any upper gestational age limit, if there is a strong probability that the fetus will&#xD;
      be affected by a particularly severe and incurable disease. When there is a lethal fetal&#xD;
      diagnosis most of parents wish to terminate their pregnancy. However, and despite some&#xD;
      medical resistance a few of them do wish to continue pregnancy. In these situations,&#xD;
      palliative care seems to be a good way to prepare to welcome the child and surround him until&#xD;
      death.&#xD;
&#xD;
      The aim of the study is to describe parents' experience for a better understanding and a&#xD;
      better care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">April 11, 2019</completion_date>
  <primary_completion_date type="Actual">April 11, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis</measure>
    <time_frame>About 1 hour and 30 minutes</time_frame>
    <description>The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.</description>
  </primary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>Fetal Death</condition>
  <condition>Fetal Anomaly</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Semi-structured interviews</intervention_name>
    <description>The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will focus on couples who have been diagnosed with lethal fetal pathology and&#xD;
        who have chosen to continue the pregnancy for a birth in palliative care.&#xD;
&#xD;
        The death of the child may have occurred in utero or after birth.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The woman must be between the ages of 18 and 50 and the adult,&#xD;
&#xD;
          -  Participants must have received the information and not have objected to participating&#xD;
             in the study,&#xD;
&#xD;
          -  the lethal / adverse short-term prognosis of the fetal pathology must have been&#xD;
             confirmed by a committee of experts (CPDPN),&#xD;
&#xD;
          -  The choice to continue the pregnancy should have been clearly expressed,&#xD;
&#xD;
          -  The birth of the child should not be older than 24 months.&#xD;
&#xD;
          -  The child's death must be more than 6 months old (or not have occurred)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-mastery of the French language,&#xD;
&#xD;
          -  Measure of legal protection of one of the members of the couple (guardianship,&#xD;
             trusteeship, ...),&#xD;
&#xD;
          -  Severe psychiatric or neurological disorders inducing significant cognitive&#xD;
             impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie obstétrique - Hôpital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique - Centre hospitalier Lyon sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>August 28, 2019</last_update_submitted>
  <last_update_submitted_qc>August 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</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>Fetal Death</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03795857
org study id: 69HCL18_0371
nct id: NCT03795857
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In France, according to current legislation, termination of pregnancy could be performed
      without any upper gestational age limit, if there is a strong probability that the fetus will
      be affected by a particularly severe and incurable disease. When there is a lethal fetal
      diagnosis most of parents wish to terminate their pregnancy. However, and despite some
      medical resistance a few of them do wish to continue pregnancy. In these situations,
      palliative care seems to be a good way to prepare to welcome the child and surround him until
      death.

      The aim of the study is to describe parents' experience for a better understanding and a
      better care.
observational model: Other
time perspective: Prospective
measure: Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis
time frame: About 1 hour and 30 minutes
description: The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.
intervention type: Behavioral
intervention name: Semi-structured interviews
description: The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Fetal Death
mesh term: Congenital Abnormalities
sharing ipd: No