<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/NCT04506489</url>
  </required_header>
  <id_info>
    <org_study_id>P/2019/434</org_study_id>
    <nct_id>NCT04506489</nct_id>
  </id_info>
  <brief_title>Access to Maternity and Risk Factors in a Non-consultant Population (PROXIMA)</brief_title>
  <official_title>Access to Maternity and Risk Factors in a Non-consultant Population - Longitudinal and Prospective Exploratory Study (PROXIMA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      Characterize the psychic and medical disorders related to pregnancy and motherhood in a group&#xD;
      of primiparous and primigratic women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience</measure>
    <time_frame>3 to 4 months of pregnancy</time_frame>
    <description>units (scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience</measure>
    <time_frame>8-9 months of pregnancy</time_frame>
    <description>units (scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience</measure>
    <time_frame>15 days to 1 month after birth</time_frame>
    <description>units (scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience</measure>
    <time_frame>3 months after birth</time_frame>
    <description>units (scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience</measure>
    <time_frame>6 months after birth</time_frame>
    <description>units (scale)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Post Partum Depression</condition>
  <arm_group>
    <arm_group_label>Psychological investigation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychological investigation</intervention_name>
    <description>Psychological tests, psychological interviews.</description>
    <arm_group_label>Psychological investigation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primiparous women without mental and obstetric disorders monitoring in the Besançon&#xD;
        University Hospital, during their pregnancy and after their birth.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primiparous and primigest women,&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Consultant at the University Hospital of Besançon in gynecology / obstetrics&#xD;
             department - initial consultation&#xD;
&#xD;
          -  25 to 45 years old,&#xD;
&#xD;
          -  European culture and speaking French,&#xD;
&#xD;
          -  Living in a relationship with the spouse&#xD;
&#xD;
          -  Spontaneous pregnancy, without medical help&#xD;
&#xD;
          -  Having agreed to the use of this medical data as part of this research and the&#xD;
             completion of the self-questionnaires.&#xD;
&#xD;
          -  Patients who benefit from a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Termination of pregnancy or non-progressive pregnancy&#xD;
&#xD;
          -  Prematurity of the child (Childbirth before 37 weeks)&#xD;
&#xD;
          -  Maternal pathologies acquired during pregnancy&#xD;
&#xD;
          -  Fetal diseases acquired during pregnancy&#xD;
&#xD;
          -  Pregnancy of twins or triplets&#xD;
&#xD;
          -  Any type of medical difficulties occurring during pregnancy (gestational diabetes,&#xD;
             high blood pressure, threat of preterm delivery, preeclampsia, ...)&#xD;
&#xD;
          -  Any type of difficulty occurring during childbirth for example, hemorrhage of maternal&#xD;
             deliverance&#xD;
&#xD;
          -  Birth by cesarean section Birth necessitating the use of instruments that led to the&#xD;
             transfer of the baby to the neonatology unit or to the kangaroo unit&#xD;
&#xD;
          -  At birth, baby's Apgar less than 7.&#xD;
&#xD;
          -  Fetal death&#xD;
&#xD;
          -  Childbirth that did not occur at the CHU maternity ward&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mottet Nicolas, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Besançon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Belot Rose Angélique, MCF</last_name>
    <phone>0680188113</phone>
    <email>rose-angelique.belot@univ-fcomte.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pointurier Mathilde</last_name>
    <email>mathilde.pointurier@edu.univ-fcomte.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mathilde Pointurier</name>
      <address>
        <city>Besançon</city>
        <state>Franche Comté</state>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathilde Pointurier</last_name>
      <phone>0647228661</phone>
      <email>mathildep718@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</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>Depression, Postpartum</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/NCT04506489
org study id: P/2019/434
nct id: NCT04506489
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Characterize the psychic and medical disorders related to pregnancy and motherhood in a group
      of primiparous and primigratic women.
observational model: Cohort
time perspective: Prospective
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
time frame: 3 to 4 months of pregnancy
description: units (scale)
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
time frame: 8-9 months of pregnancy
description: units (scale)
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
time frame: 15 days to 1 month after birth
description: units (scale)
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
time frame: 3 months after birth
description: units (scale)
measure: Self questionnaire : health, Anxiety, Postnatal, Body Satisfaction, , Bartholomew, RelationShip, Social , Perinatal, Family Relationship , parental stress, dyadic alliance, Parental Bonding , Prenatal attachment , birth experience
time frame: 6 months after birth
description: units (scale)
arm group label: Psychological investigation
intervention type: Other
intervention name: Psychological investigation
description: Psychological tests, psychological interviews.
arm group label: Psychological investigation
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mottet Nicolas, Dr
role: Principal Investigator
affiliation: CHU Besançon
last name: Belot Rose Angélique, MCF
phone: 0680188113
email: rose-angelique.belot@univ-fcomte.fr
last name: Pointurier Mathilde
email: mathilde.pointurier@edu.univ-fcomte.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Depression, Postpartum