<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/NCT03260959</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0073</org_study_id>
    <nct_id>NCT03260959</nct_id>
  </id_info>
  <brief_title>Experience of the Father Following the Announcement of a First Pregnancy</brief_title>
  <official_title>Experience of the Father Following the Announcement of a First Pregnancy</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>
      Experience of the father following the announcement of a first pregnancy Its context,&#xD;
      immediate reactions and actions. Possible impact of this moment of life a few months or years&#xD;
      later?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Actual">November 10, 2017</completion_date>
  <primary_completion_date type="Actual">November 10, 2017</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>Interview by hierarchical evocation's method</measure>
    <time_frame>30-45 minutes</time_frame>
    <description>Experience of the man during the announcement of a pregnancy that it is expected or not, without identification of an average answer, but description of the diversity of situations, contexts, felt, taken of decision and actions.&#xD;
Since this study is observational and descriptive, it does not have a primary judgment criterion, the aim being to describe the studied population. However, according to the method of hierarchical evocation, it can be said that the average frequency of occurrence of the words and their average polarity index will be some outcome measure.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Family Relations</condition>
  <condition>Behavior</condition>
  <arm_group>
    <arm_group_label>Father</arm_group_label>
    <description>Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interview by hierarchical evocation's Method</intervention_name>
    <description>Interview to describe the experience of the man during the announcement of a pregnancy that it is expected or not.</description>
    <arm_group_label>Father</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male having been the father of at least one pregnancy whatever the outcome (pregnancy&#xD;
        pursued, or abortion)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Male having been the father of at least one pregnancy whatever the outcome (pregnancy&#xD;
        pursued, or abortion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe or neurological psychiatric disorders inducing significant&#xD;
             cognitive impairment&#xD;
&#xD;
          -  Patients who do not master the French language&#xD;
&#xD;
          -  Patients who cannot give free and informed consent (guardianship, curatorship,&#xD;
             safeguard of justice ...)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cabinet de médecine générale</name>
      <address>
        <city>Beynost</city>
        <zip>01700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet de médecine générale</name>
      <address>
        <city>Crémieu</city>
        <zip>38460</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet de médecine générale</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet de médecine générale</name>
      <address>
        <city>Vallon-Pont-d'Arc</city>
        <zip>07150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet de médecine générale</name>
      <address>
        <city>Vaugneray</city>
        <zip>69670</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03260959
org study id: 69HCL17_0073
nct id: NCT03260959
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Experience of the father following the announcement of a first pregnancy Its context,
      immediate reactions and actions. Possible impact of this moment of life a few months or years
      later?
observational model: Other
time perspective: Prospective
measure: Interview by hierarchical evocation's method
time frame: 30-45 minutes
description: Experience of the man during the announcement of a pregnancy that it is expected or not, without identification of an average answer, but description of the diversity of situations, contexts, felt, taken of decision and actions.
Since this study is observational and descriptive, it does not have a primary judgment criterion, the aim being to describe the studied population. However, according to the method of hierarchical evocation, it can be said that the average frequency of occurrence of the words and their average polarity index will be some outcome measure.
arm group label: Father
description: Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion)
intervention type: Behavioral
intervention name: Interview by hierarchical evocation's Method
description: Interview to describe the experience of the man during the announcement of a pregnancy that it is expected or not.
arm group label: Father
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No