<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/NCT04489602</url>
  </required_header>
  <id_info>
    <org_study_id>ObsQoR-10F</org_study_id>
    <nct_id>NCT04489602</nct_id>
  </id_info>
  <brief_title>Translation and Validation of the French Version of the ObsQoR-10 Questionnaire</brief_title>
  <acronym>ObsQoR-10F</acronym>
  <official_title>Translation and Validation of the French Version of the ObsQoR-10 Questionnaire for the Evaluation of Recovery After Childbirth: the ObsQoR-10F Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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>
      Until recently, there was no validated scoring tool to assess recovery after childbirth.&#xD;
      Ciechanowicz et al. developed and validated a postpartum recovery score for women with a&#xD;
      caesarean section (scheduled or unscheduled): the ObsQoR-11. The psychometric validation of&#xD;
      the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its&#xD;
      feasibility (average filling time of 2 minutes, and the possibility to print the&#xD;
      questionnaire on one page). The use of this score allows the investigators to quantify the&#xD;
      quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110&#xD;
      a total recovery), by allocating a score from 0 to 10 for each item.&#xD;
&#xD;
      Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10,&#xD;
      for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for&#xD;
      each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery&#xD;
      between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).&#xD;
&#xD;
      There are currently no translations of this score into another language, but the&#xD;
      investigators can easily assume that they will be done in the near future. French remains the&#xD;
      fifth most spoken language in the world. The investigators therefore feel it is necessary to&#xD;
      validate the translated version of the ObsQoR-10 score.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recovery after childbirth (by caesarean section or vaginal delivery) is a complex process,&#xD;
      depending on the characteristics of the patient, the anaesthesia, and the need for surgery or&#xD;
      an instrumental device. This event is a source of stress, anxiety and pain, and can also lead&#xD;
      to postpartum complications. Studies evaluating interventions during childbirth traditionally&#xD;
      focus on mortality and morbidity which, although important, do not describe the patient's&#xD;
      experience or the quality of her recovery.&#xD;
&#xD;
      Scores for measuring the quality of post-operative recovery have been developed. These&#xD;
      scoring tools accurately measure post-operative recovery by looking at some dimensions of the&#xD;
      patient's experience. However, they have been developed and validated in non-obstetrical&#xD;
      patients. They therefore contain aspects of recovery that are not relevant to delivery and&#xD;
      postpartum. Furthermore, they do not include key elements, such as the ability to care for&#xD;
      the newborn.&#xD;
&#xD;
      Until recently, there was no validated scoring tool to assess recovery after childbirth.&#xD;
      Ciechanowicz et al. developed and validated a postpartum recovery score for women with a&#xD;
      caesarean section (scheduled or unscheduled): the ObsQoR-11. This multidimensional score is a&#xD;
      questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting,&#xD;
      feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry&#xD;
      the newborn, ability to feed, ability to groom alone, and finally feeling of self-control.&#xD;
      The psychometric validation of the ObsQoR-11 confirms its reliability, its response to&#xD;
      change, its acceptability and its feasibility (average filling time of 2 minutes, and the&#xD;
      possibility to print the questionnaire on one page). The use of this score allows to quantify&#xD;
      the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and&#xD;
      110 a total recovery), by allocating a score from 0 to 10 for each item.&#xD;
&#xD;
      This tool has the advantage of efficiently evaluating the concept of immediate postpartum&#xD;
      recovery, with an acceptable feasibility for both the patient and the caregivers. Since then,&#xD;
      the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the&#xD;
      pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the&#xD;
      ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0&#xD;
      being a very poor recovery, and 100 being full recovery).&#xD;
&#xD;
      There are currently no translations of this score into another language, but the&#xD;
      investigators can easily assume that they will be done in the near future. French remains the&#xD;
      fifth most spoken language in the world. The investigators therefore feel it is necessary to&#xD;
      validate the translated version of the ObsQoR-10 score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of ObsQoR-10F questionnaire</measure>
    <time_frame>2 days</time_frame>
    <description>Evaluate the validity of the French version of the ObsQoR-10 to assess immediate postpartum recovery (at 24 and 48 hours after vaginal delivery or Caesarean section).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validity of ObsQoR-10F questionnaire (Caesarean section)</measure>
    <time_frame>2 days</time_frame>
    <description>Ensure the validity of the questionnaire in the sub-population of Caesarean delivery population (scheduled and unscheduled) at 24 and 48 hours</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Validity of ObsQoR-10F questionnaire (Vaginal delivery)</measure>
    <time_frame>2 days</time_frame>
    <description>Assess the validity of the questionnaire specifically in the subpopulation of patients with a vaginal delivery (with or without instrumental extraction) at 24 and 48 hours</description>
  </other_outcome>
  <other_outcome>
    <measure>Minimal important difference</measure>
    <time_frame>2 days</time_frame>
    <description>Estimate minimal important difference from the ObsQoR-10F questionnaire</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Delivery</condition>
  <condition>Childbirth</condition>
  <condition>Patient Reported Outcome Measures</condition>
  <condition>Labor Complication</condition>
  <condition>Quality of Recovery</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <description>Each patient complete ObsQoR-10F questionnaire 3 times (before delivery, on Day 1, on Day 2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ObsQoR-10F Questionnaire</intervention_name>
    <description>The ObsQoR-10F questionnaire consists of 10 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. It takes two minutes to complete all the items. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. If the patient has returned home with her child, she can be contacted by phone to complete the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted for spontaneous obstetrical labor, induction of obstetrical labor, or&#xD;
        scheduled cesarean section.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old);&#xD;
&#xD;
          -  French-speaking;&#xD;
&#xD;
          -  Admitted for spontaneous obstetrical labor, induction of obstetrical labor, or&#xD;
             scheduled cesarean section;&#xD;
&#xD;
          -  Able to answer the questionnaire, alone or with the help of a third party;&#xD;
&#xD;
          -  Agreeing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric or neurological pathology compromising cooperation in the questionnaire&#xD;
             validation protocol,&#xD;
&#xD;
          -  Psychological history (medical termination of pregnancy, foetal death in utero).&#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_contact>
    <last_name>Maxime Léger, MD</last_name>
    <phone>2 41 35 36 35</phone>
    <phone_ext>+33</phone_ext>
    <email>maxime.leger@chu-angers.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Béatrice Gable</last_name>
    <phone>2 41 35 68 25</phone>
    <phone_ext>+33</phone_ext>
    <email>begable@chu-angers.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Angers</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maxime Léger, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.</citation>
    <PMID>30579408</PMID>
  </reference>
  <reference>
    <citation>Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20.</citation>
    <PMID>32203873</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2021</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>Obstetric Labor Complications</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/NCT04489602
org study id: ObsQoR-10F
nct id: NCT04489602
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Until recently, there was no validated scoring tool to assess recovery after childbirth.
      Ciechanowicz et al. developed and validated a postpartum recovery score for women with a
      caesarean section (scheduled or unscheduled): the ObsQoR-11. The psychometric validation of
      the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its
      feasibility (average filling time of 2 minutes, and the possibility to print the
      questionnaire on one page). The use of this score allows the investigators to quantify the
      quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110
      a total recovery), by allocating a score from 0 to 10 for each item.

      Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10,
      for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for
      each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery
      between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).

      There are currently no translations of this score into another language, but the
      investigators can easily assume that they will be done in the near future. French remains the
      fifth most spoken language in the world. The investigators therefore feel it is necessary to
      validate the translated version of the ObsQoR-10 score.
Recovery after childbirth (by caesarean section or vaginal delivery) is a complex process,
      depending on the characteristics of the patient, the anaesthesia, and the need for surgery or
      an instrumental device. This event is a source of stress, anxiety and pain, and can also lead
      to postpartum complications. Studies evaluating interventions during childbirth traditionally
      focus on mortality and morbidity which, although important, do not describe the patient's
      experience or the quality of her recovery.

      Scores for measuring the quality of post-operative recovery have been developed. These
      scoring tools accurately measure post-operative recovery by looking at some dimensions of the
      patient's experience. However, they have been developed and validated in non-obstetrical
      patients. They therefore contain aspects of recovery that are not relevant to delivery and
      postpartum. Furthermore, they do not include key elements, such as the ability to care for
      the newborn.

      Until recently, there was no validated scoring tool to assess recovery after childbirth.
      Ciechanowicz et al. developed and validated a postpartum recovery score for women with a
      caesarean section (scheduled or unscheduled): the ObsQoR-11. This multidimensional score is a
      questionnaire of 11 items evaluating: moderate pain, severe pain, nausea and vomiting,
      feeling of discomfort, shivering, feeling of comfort, ability to mobilize, ability to carry
      the newborn, ability to feed, ability to groom alone, and finally feeling of self-control.
      The psychometric validation of the ObsQoR-11 confirms its reliability, its response to
      change, its acceptability and its feasibility (average filling time of 2 minutes, and the
      possibility to print the questionnaire on one page). The use of this score allows to quantify
      the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and
      110 a total recovery), by allocating a score from 0 to 10 for each item.

      This tool has the advantage of efficiently evaluating the concept of immediate postpartum
      recovery, with an acceptable feasibility for both the patient and the caregivers. Since then,
      the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the
      pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the
      ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0
      being a very poor recovery, and 100 being full recovery).

      There are currently no translations of this score into another language, but the
      investigators can easily assume that they will be done in the near future. French remains the
      fifth most spoken language in the world. The investigators therefore feel it is necessary to
      validate the translated version of the ObsQoR-10 score.
observational model: Case-Only
time perspective: Prospective
measure: Validity of ObsQoR-10F questionnaire
time frame: 2 days
description: Evaluate the validity of the French version of the ObsQoR-10 to assess immediate postpartum recovery (at 24 and 48 hours after vaginal delivery or Caesarean section).
measure: Validity of ObsQoR-10F questionnaire (Caesarean section)
time frame: 2 days
description: Ensure the validity of the questionnaire in the sub-population of Caesarean delivery population (scheduled and unscheduled) at 24 and 48 hours
measure: Validity of ObsQoR-10F questionnaire (Vaginal delivery)
time frame: 2 days
description: Assess the validity of the questionnaire specifically in the subpopulation of patients with a vaginal delivery (with or without instrumental extraction) at 24 and 48 hours
measure: Minimal important difference
time frame: 2 days
description: Estimate minimal important difference from the ObsQoR-10F questionnaire
arm group label: Intervention
description: Each patient complete ObsQoR-10F questionnaire 3 times (before delivery, on Day 1, on Day 2)
intervention type: Other
intervention name: ObsQoR-10F Questionnaire
description: The ObsQoR-10F questionnaire consists of 10 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. It takes two minutes to complete all the items. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. If the patient has returned home with her child, she can be contacted by phone to complete the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.
arm group label: Intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maxime Léger, MD
phone: 2 41 35 36 35
phone ext: +33
email: maxime.leger@chu-angers.fr
last name: Béatrice Gable
phone: 2 41 35 68 25
phone ext: +33
email: begable@chu-angers.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.
PMID: 30579408
citation: Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20.
PMID: 32203873
responsible party type: Sponsor
mesh term: Obstetric Labor Complications
sharing ipd: No