<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/NCT04423081</url>
  </required_header>
  <id_info>
    <org_study_id>RNI 2020 GALLOT</org_study_id>
    <secondary_id>2020-A01286-33.</secondary_id>
    <nct_id>NCT04423081</nct_id>
  </id_info>
  <brief_title>Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) (EXIT)</brief_title>
  <acronym>EXIT</acronym>
  <official_title>Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) Self-questionnaire Assessing Women's Feelings About the Onset of Childbirth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      The objective of the study is to cross-culturally adapt and validate the French version of&#xD;
      the EXIT scale: an assessment tool on induction of labor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Favourable agreement was obtained from the authors to adapt the Australian moose tool in a&#xD;
      cross-cultural manner. None of the co-authors expressed a desire to collaborate on our&#xD;
      project. The EXIT questionnaire is free of rights.&#xD;
&#xD;
      The translation of the EXIT questionnaire into French will be carried out according to the&#xD;
      recommended steps of the cross-cultural adaptation process (21, 22, 25): translation of the&#xD;
      source version into French by three native French translators, adaptation of the different&#xD;
      translations by a group of experts, back translation by two native English speakers, testing&#xD;
      with a panel of women who have been triggered for childbirth, in order to arrive at the final&#xD;
      version which will be evaluated in a sample of the target population.&#xD;
&#xD;
      Information about the study will be given to women between Day 2 and Day 4 postpartum.&#xD;
      Patients' non-opposition to participate in this study will be collected in the patient's&#xD;
      medical record.&#xD;
&#xD;
      Recruitment of subjects: the study will be proposed to all eligible women who have been&#xD;
      induced for their delivery and with an unfavourable cervix in the obstetrics department of&#xD;
      the CHU Estaing, Clermont-Ferrand.&#xD;
&#xD;
      Completion of the questionnaire: women will complete the EXIT self-questionnaire between D2&#xD;
      and D4 post-delivery.&#xD;
&#xD;
      The data collection will include additional socio-demographic and clinical information for&#xD;
      each woman participating in the study from their medical records.&#xD;
&#xD;
      The test-retest involves filling in the EXIT questionnaire twice at one to two week&#xD;
      intervals.&#xD;
&#xD;
      The women will be contacted by phone one week after the first EXIT test, to inform them that&#xD;
      a link will be sent by e-mail to complete the EXIT questionnaire online (on Redcap) a second&#xD;
      time. They will be called back a second time a week later if the questionnaire is not&#xD;
      completed online.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>The psychometric properties of the French version of the EXperiences of Induction Tool</measure>
    <time_frame>Day 2</time_frame>
    <description>The psychometric properties of the French version of the EXperiences of Induction Tool include: acceptability, internal structure validity, convergent validity, structure validity against external criteria and reproducibility. EXperiences of Induction Tool is composed of 3 dimensions: &quot;Time taken to give birth&quot;, &quot;Discomfort with IOL&quot; and &quot;Experience of subsequent contractions&quot;. Each dimension has a minimum score of 0 and a maximum score of 5. For the dimension &quot;Time taken to give birth, a high score mean a more positive feeling. For &quot;Discomfort with IOL&quot;a high score mean more discomfort. For &quot;Experience of subsequent contractions&quot;, a high score mean a more positive feeling.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score of the EXperiences of Induction Tool</measure>
    <time_frame>Day 2</time_frame>
    <description>Score of the EXperiences of Induction Tool will be calculated. EXperiences of Induction Tool is composed of 3 dimensions: &quot;Time taken to give birth&quot;, &quot;Discomfort with IOL&quot; and &quot;Experience of subsequent contractions&quot;. Each dimension has a minimum score of 0 and a maximum score of 5. For the dimension &quot;Time taken to give birth, a high score mean a more positive feeling. For &quot;Discomfort with IOL&quot;a high score mean more discomfort. For &quot;Experience of subsequent contractions&quot;, a high score mean a more positive feeling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of birth</measure>
    <time_frame>at birth</time_frame>
    <description>delay between induction of labor and birth will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time of labor start</measure>
    <time_frame>at birth</time_frame>
    <description>delay between induction of labor and labor start will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Methods of induction of labor</measure>
    <time_frame>at birth</time_frame>
    <description>the type of strategy used for induction of labor will be recored</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal complications</measure>
    <time_frame>up to 1 week</time_frame>
    <description>maternal complications include intra-uterine infection, endometritis, c-section, instrumental delivery, post-partum hemorhage, episiotomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal complications</measure>
    <time_frame>up to 1 week</time_frame>
    <description>maternal complications include Apgar score &lt; 7 to 5min, pH and lactates on umbilical arterial sampling, 2nd line operation, and rate of transfer to Intensive care unit, maternal-fetal infection</description>
  </secondary_outcome>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Induction of Labor</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EXIT scale</intervention_name>
    <description>completion of EXIT scale translated in french</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having given birth in the obstetrics department of CHU Estaing, Clermont-Ferrand&#xD;
        with an induction of labor and with an unfavorable cervix (Bishop score &lt;6)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having given birth in the obstetrics department of CHU Estaing,&#xD;
             Clermont-Ferrand&#xD;
&#xD;
          -  with an induction of labor&#xD;
&#xD;
          -  with an unfavorable cervix (Bishop score &lt;6)&#xD;
&#xD;
          -  on living child(ren)&#xD;
&#xD;
          -  Patients aged 18 years and over, understanding, speaking and reading French&#xD;
&#xD;
          -  no object to participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients induced at first with syntocinon.&#xD;
&#xD;
          -  Patients who do not have an internet connection and an e-mail address.&#xD;
&#xD;
          -  Patients under legal protection (guardianship, tutorship).&#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>Denis Gallot</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>+33473754963</phone>
    <email>promo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Lise Laclautre</last_name>
      <phone>+33473754963</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Denis Gallot</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EXIT scale</keyword>
  <keyword>induction of labor</keyword>
  <!-- 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/NCT04423081
org study id: RNI 2020 GALLOT
secondary id: 2020-A01286-33.
nct id: NCT04423081
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to cross-culturally adapt and validate the French version of
      the EXIT scale: an assessment tool on induction of labor.
Favourable agreement was obtained from the authors to adapt the Australian moose tool in a
      cross-cultural manner. None of the co-authors expressed a desire to collaborate on our
      project. The EXIT questionnaire is free of rights.

      The translation of the EXIT questionnaire into French will be carried out according to the
      recommended steps of the cross-cultural adaptation process (21, 22, 25): translation of the
      source version into French by three native French translators, adaptation of the different
      translations by a group of experts, back translation by two native English speakers, testing
      with a panel of women who have been triggered for childbirth, in order to arrive at the final
      version which will be evaluated in a sample of the target population.

      Information about the study will be given to women between Day 2 and Day 4 postpartum.
      Patients' non-opposition to participate in this study will be collected in the patient's
      medical record.

      Recruitment of subjects: the study will be proposed to all eligible women who have been
      induced for their delivery and with an unfavourable cervix in the obstetrics department of
      the CHU Estaing, Clermont-Ferrand.

      Completion of the questionnaire: women will complete the EXIT self-questionnaire between D2
      and D4 post-delivery.

      The data collection will include additional socio-demographic and clinical information for
      each woman participating in the study from their medical records.

      The test-retest involves filling in the EXIT questionnaire twice at one to two week
      intervals.

      The women will be contacted by phone one week after the first EXIT test, to inform them that
      a link will be sent by e-mail to complete the EXIT questionnaire online (on Redcap) a second
      time. They will be called back a second time a week later if the questionnaire is not
      completed online.
observational model: Cohort
time perspective: Prospective
measure: The psychometric properties of the French version of the EXperiences of Induction Tool
time frame: Day 2
description: The psychometric properties of the French version of the EXperiences of Induction Tool include: acceptability, internal structure validity, convergent validity, structure validity against external criteria and reproducibility. EXperiences of Induction Tool is composed of 3 dimensions: "Time taken to give birth", "Discomfort with IOL" and "Experience of subsequent contractions". Each dimension has a minimum score of 0 and a maximum score of 5. For the dimension "Time taken to give birth, a high score mean a more positive feeling. For "Discomfort with IOL"a high score mean more discomfort. For "Experience of subsequent contractions", a high score mean a more positive feeling.
measure: Score of the EXperiences of Induction Tool
time frame: Day 2
description: Score of the EXperiences of Induction Tool will be calculated. EXperiences of Induction Tool is composed of 3 dimensions: "Time taken to give birth", "Discomfort with IOL" and "Experience of subsequent contractions". Each dimension has a minimum score of 0 and a maximum score of 5. For the dimension "Time taken to give birth, a high score mean a more positive feeling. For "Discomfort with IOL"a high score mean more discomfort. For "Experience of subsequent contractions", a high score mean a more positive feeling.
measure: Time of birth
time frame: at birth
description: delay between induction of labor and birth will be calculated
measure: time of labor start
time frame: at birth
description: delay between induction of labor and labor start will be calculated
measure: Methods of induction of labor
time frame: at birth
description: the type of strategy used for induction of labor will be recored
measure: Maternal complications
time frame: up to 1 week
description: maternal complications include intra-uterine infection, endometritis, c-section, instrumental delivery, post-partum hemorhage, episiotomy
measure: Neonatal complications
time frame: up to 1 week
description: maternal complications include Apgar score < 7 to 5min, pH and lactates on umbilical arterial sampling, 2nd line operation, and rate of transfer to Intensive care unit, maternal-fetal infection
intervention type: Other
intervention name: EXIT scale
description: completion of EXIT scale translated in french
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Denis Gallot
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Lise LACLAUTRE
phone: +33473754963
email: promo_interne_drci@chu-clermontferrand.fr
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor