xml: <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/NCT06002763</url>
    </required_header>
    <id_info>
      <org_study_id>23-03</org_study_id>
      <nct_id>NCT06002763</nct_id>
    </id_info>
    <brief_title>Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women</brief_title>
    <official_title>Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</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>
        There is no widely used, statistically validated assessment for physical and mental health&#xD;
        for the short- to medium-term in a postpartum population. PROMIS-29 has been validated for&#xD;
        the assessment of these factors in a generic population, but has not been specifically&#xD;
        evaluated for use with postpartum women.&#xD;
  &#xD;
        This study is a longitudinal, single center observational cohort study designed to evaluate&#xD;
        the reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29&#xD;
        v2.1 survey in a postpartum population. PROMIS-29 is a survey designed to screen for pain,&#xD;
        impairments in mood, physical function, and activities of daily living. While this survey has&#xD;
        shown utility in other populations, it has yet to be assessed in an obstetric population. The&#xD;
        investigators plan to recruit patients who are recently postpartum from vaginal or cesarean&#xD;
        delivery to complete virtual surveys at defined time points (0, 2, 6, and 12 weeks after&#xD;
        delivery). The investigators will subject survey data to statistical measures of validity and&#xD;
        reliability comparing with contemporaneously collected surveys of established metrics for&#xD;
        quality of life (WHOQoLBREF) and general (global) state of health (numerical rating score&#xD;
        1-100).&#xD;
  &#xD;
        The hypothesis is that the PROMIS-29 v2.1 questionnaire is a statistically valid and reliable&#xD;
        means of assessing physical and mental health in a postpartum population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score</measure>
      <time_frame>24 hours</time_frame>
      <description>The PROMIS survey score at 24 hours postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score</measure>
      <time_frame>24 hours</time_frame>
      <description>The WHOQoLBREF survey score at 24 hours postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EQ-5D-3L1 (not an acronym) survey score</measure>
      <time_frame>24 hours</time_frame>
      <description>The EQ-5D-3L1 survey score at 24 hours postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score</measure>
      <time_frame>2 weeks</time_frame>
      <description>The PROMIS survey score at 2 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score</measure>
      <time_frame>2 weeks</time_frame>
      <description>The WHOQoLBREF survey score at 2 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EQ-5D-3L1 (not an acronym) survey score</measure>
      <time_frame>2 weeks</time_frame>
      <description>The EQ-5D-3L1 survey score at 2 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score</measure>
      <time_frame>6 weeks</time_frame>
      <description>The PROMIS survey scores at 6 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score</measure>
      <time_frame>6 weeks</time_frame>
      <description>The WHOQoLBREF survey score at 6 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EQ-5D-3L1 (not an acronym) survey score</measure>
      <time_frame>6 weeks</time_frame>
      <description>The EQ-5D-3L1 survey score at 6 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score</measure>
      <time_frame>12 weeks</time_frame>
      <description>The PROMIS survey score at 12 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score</measure>
      <time_frame>12 weeks</time_frame>
      <description>The WHOQoLBREF survey score at 12 weeks postpartum</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EQ-5D-3L1 (not an acronym) survey score</measure>
      <time_frame>12 weeks</time_frame>
      <description>The EQ-5D-3L1 survey score at 12 weeks postpartum</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Well-Being, Psychological</condition>
    <arm_group>
      <arm_group_label>Vaginal delivery</arm_group_label>
      <description>Patients who have vaginal deliveries with neuraxial labour analgesia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cesarean delivery</arm_group_label>
      <description>Patients who have a scheduled cesarean delivery with neuraxial anesthesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)</intervention_name>
      <description>PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living.</description>
      <arm_group_label>Cesarean delivery</arm_group_label>
      <arm_group_label>Vaginal delivery</arm_group_label>
      <other_name>Patient-Reported Outcomes Measurement Information System</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>WHOQoLBREF (World Health Organization Quality of Life Brief Version)</intervention_name>
      <description>The WHOQOL-BREF is a 26-item version of the 100-item WHOQOL-100 quality of life measure that addresses four quality of life domains: physical health, psychological health, social relationships and environment.</description>
      <arm_group_label>Cesarean delivery</arm_group_label>
      <arm_group_label>Vaginal delivery</arm_group_label>
      <other_name>World Health Organization Quality of Life Brief Version</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>EQ-5D-3L1 (not an acronym)</intervention_name>
      <description>The EQ-5D-3L1 is a generic measure of health status consisting of two parts. The first part assesses health in five dimensions: MOBILITY, SELFCARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY/DEPRESSION. The second part of the questionnaire consists of a VAS on which the patient rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).</description>
      <arm_group_label>Cesarean delivery</arm_group_label>
      <arm_group_label>Vaginal delivery</arm_group_label>
      <other_name>Global state of health numerical rating score 1-100</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who delivery vaginally or by scheduled cesarean section at Mount Sinai Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years old and over&#xD;
  &#xD;
            -  singleton births&#xD;
  &#xD;
            -  37 or more weeks gestational age&#xD;
  &#xD;
            -  multiparous or nulliparous patients&#xD;
  &#xD;
            -  spontaneous vaginal delivery or scheduled cesarean delivery with labor analgesia or&#xD;
               neuraxial anesthesia&#xD;
  &#xD;
            -  give informed written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  refusal to take part&#xD;
  &#xD;
            -  are unable to give or have withdrawn consent&#xD;
  &#xD;
            -  patients unable to communicate fluently in English&#xD;
  &#xD;
            -  patients who are less than 18 years old&#xD;
  &#xD;
            -  patients who had fetal demise or severely morbid fetal conditions such as intubation,&#xD;
               cooling, expected surgical correction of congenital anomaly during hospitalization&#xD;
               (although NICU admissions will be included)&#xD;
  &#xD;
            -  patients who were admitted in ICU&#xD;
  &#xD;
            -  patients who had failed neuraxial analgesia such as replaced epidurals or failed&#xD;
               spinal requiring conversion to general anesthesia&#xD;
  &#xD;
            -  patients who had general anesthesia for cesarean delivery as defined by &quot;GETA&quot;,&#xD;
               including sedatives and deep sedation if not intubated&#xD;
  &#xD;
            -  patients who had intrapartum cesarean or had assisted/operative (i.e. vacuum, forceps)&#xD;
               vaginal delivery.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ronald George, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>MOUNT SINAI HOSPITAL</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ronald George, MD</last_name>
      <phone>416-586-4800</phone>
      <phone_ext>2681</phone_ext>
      <email>ron.george@uhn.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mount Sinai Hospital</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5G1X5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Ronald George, MD</last_name>
        <phone>416-586-4800</phone>
        <phone_ext>2681</phone_ext>
        <email>ron.george@uhn.ca</email>
      </contact>
      <investigator>
        <last_name>Denise Medeiros, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kristi Downey, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cesarean delivery</keyword>
    <keyword>vaginal delivery</keyword>
    <keyword>postpartum recovery</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002763
  org study id: 23-03
  nct id: NCT06002763
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There is no widely used, statistically validated assessment for physical and mental health
        for the short- to medium-term in a postpartum population. PROMIS-29 has been validated for
        the assessment of these factors in a generic population, but has not been specifically
        evaluated for use with postpartum women.
  
        This study is a longitudinal, single center observational cohort study designed to evaluate
        the reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29
        v2.1 survey in a postpartum population. PROMIS-29 is a survey designed to screen for pain,
        impairments in mood, physical function, and activities of daily living. While this survey has
        shown utility in other populations, it has yet to be assessed in an obstetric population. The
        investigators plan to recruit patients who are recently postpartum from vaginal or cesarean
        delivery to complete virtual surveys at defined time points (0, 2, 6, and 12 weeks after
        delivery). The investigators will subject survey data to statistical measures of validity and
        reliability comparing with contemporaneously collected surveys of established metrics for
        quality of life (WHOQoLBREF) and general (global) state of health (numerical rating score
        1-100).
  
        The hypothesis is that the PROMIS-29 v2.1 questionnaire is a statistically valid and reliable
        means of assessing physical and mental health in a postpartum population.
  observational model: Cohort
  time perspective: Prospective
  measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
  time frame: 24 hours
  description: The PROMIS survey score at 24 hours postpartum
  measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
  time frame: 24 hours
  description: The WHOQoLBREF survey score at 24 hours postpartum
  measure: EQ-5D-3L1 (not an acronym) survey score
  time frame: 24 hours
  description: The EQ-5D-3L1 survey score at 24 hours postpartum
  measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
  time frame: 2 weeks
  description: The PROMIS survey score at 2 weeks postpartum
  measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
  time frame: 2 weeks
  description: The WHOQoLBREF survey score at 2 weeks postpartum
  measure: EQ-5D-3L1 (not an acronym) survey score
  time frame: 2 weeks
  description: The EQ-5D-3L1 survey score at 2 weeks postpartum
  measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
  time frame: 6 weeks
  description: The PROMIS survey scores at 6 weeks postpartum
  measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
  time frame: 6 weeks
  description: The WHOQoLBREF survey score at 6 weeks postpartum
  measure: EQ-5D-3L1 (not an acronym) survey score
  time frame: 6 weeks
  description: The EQ-5D-3L1 survey score at 6 weeks postpartum
  measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
  time frame: 12 weeks
  description: The PROMIS survey score at 12 weeks postpartum
  measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
  time frame: 12 weeks
  description: The WHOQoLBREF survey score at 12 weeks postpartum
  measure: EQ-5D-3L1 (not an acronym) survey score
  time frame: 12 weeks
  description: The EQ-5D-3L1 survey score at 12 weeks postpartum
  arm group label: Vaginal delivery
  description: Patients who have vaginal deliveries with neuraxial labour analgesia.
  arm group label: Cesarean delivery
  description: Patients who have a scheduled cesarean delivery with neuraxial anesthesia.
  intervention type: Other
  intervention name: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)
  description: PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living.
  arm group label: Cesarean delivery
  arm group label: Vaginal delivery
  other name: Patient-Reported Outcomes Measurement Information System
  intervention type: Other
  intervention name: WHOQoLBREF (World Health Organization Quality of Life Brief Version)
  description: The WHOQOL-BREF is a 26-item version of the 100-item WHOQOL-100 quality of life measure that addresses four quality of life domains: physical health, psychological health, social relationships and environment.
  arm group label: Cesarean delivery
  arm group label: Vaginal delivery
  other name: World Health Organization Quality of Life Brief Version
  intervention type: Other
  intervention name: EQ-5D-3L1 (not an acronym)
  description: The EQ-5D-3L1 is a generic measure of health status consisting of two parts. The first part assesses health in five dimensions: MOBILITY, SELFCARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY/DEPRESSION. The second part of the questionnaire consists of a VAS on which the patient rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
  arm group label: Cesarean delivery
  arm group label: Vaginal delivery
  other name: Global state of health numerical rating score 1-100
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ronald George, MD
  role: Principal Investigator
  affiliation: MOUNT SINAI HOSPITAL
  last name: Ronald George, MD
  phone: 416-586-4800
  phone ext: 2681
  email: ron.george@uhn.ca
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  sharing ipd: No