<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/NCT04462107</url>
  </required_header>
  <id_info>
    <org_study_id>19-012077</org_study_id>
    <nct_id>NCT04462107</nct_id>
  </id_info>
  <brief_title>Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery</brief_title>
  <official_title>Longitudinal Study Evaluating Postpartum Recovery After Scheduled Cesarean Delivery With the Obstetric Quality of Recovery Tool</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 purpose of this research is to describe how patients recover after scheduled C-section&#xD;
      for the first 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between postpartum ObsQOR-10 and EQ-5D</measure>
    <time_frame>Baseline</time_frame>
    <description>EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between postpartum ObsQOR-10 and EQ-5D</measure>
    <time_frame>post partum=24 hours</time_frame>
    <description>EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between postpartum ObsQOR-10 and EQ-5D</measure>
    <time_frame>48 hours post partum</time_frame>
    <description>EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between postpartum ObsQOR-10 and EQ-5D</measure>
    <time_frame>1 week post partum</time_frame>
    <description>EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between postpartum ObsQOR-10 and EQ-5D</measure>
    <time_frame>3 weeks post partum</time_frame>
    <description>EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between postpartum ObsQOR-10 and EQ-5D</measure>
    <time_frame>6 weeks post partum</time_frame>
    <description>EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between postpartum ObsQOR-10 and EQ-5D</measure>
    <time_frame>3 months post partum</time_frame>
    <description>EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine change in pain levels post C-section using the Visual Analog Scale (VAS)</measure>
    <time_frame>Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months</time_frame>
    <description>Describes pain from no pain at all to the worst pain imaginable using a 100mm horizontal line</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare opioid consumption post partum</measure>
    <time_frame>24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partum</time_frame>
    <description>Compare opioid consumption post partum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare non-maternal reasons for delayed hospital discharge</measure>
    <time_frame>Hospital discharge, approximately 3 days</time_frame>
    <description>Document non-maternal reasons for delayed hospital discharge such as NICU admission of neonate, neonatal IV antibiotics, delay in transportation, delay from pediatric team.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare frequency of activities of daily living</measure>
    <time_frame>Baseline</time_frame>
    <description>Activities of daily living are routine activities people do everyday without assistance including eating, bathing, getting dressed, toileting, cooking, cleaning, driving, shopping. Subject will report these activities as not done yet, done once, once/week, do most days, do every day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare frequency of activities of daily living</measure>
    <time_frame>6 weeks</time_frame>
    <description>Activities of daily living are routine activities people do everyday without assistance including eating, bathing, getting dressed, toileting, cooking, cleaning, driving, shopping. Subject will report these activities as not done yet, done once, once/week, do most days, do every day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare Edinburgh Postnatal Depression Scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare a modified recovery after delivery questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Surveys</arm_group_label>
    <description>All participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surveys</intervention_name>
    <description>All participants will complete surveys that range in time from baseline to 3 months post partum.</description>
    <arm_group_label>Surveys</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parturients scheduled for cesarean delivery at Mayo Clinic Hospital Family Birth Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean&#xD;
             delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Gestational age less than 32 weeks&#xD;
&#xD;
          -  Women whose infants have died or are in the neonatal intensive care unit after&#xD;
             delivery&#xD;
&#xD;
          -  Inability to read or understand written English&#xD;
&#xD;
          -  Failed neuraxial anesthesia requiring general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women whom are pregnant and will have a scheduled C-section to deliver infant</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily E Sharpe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>April 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>May 11, 2022</last_update_submitted>
  <last_update_submitted_qc>May 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Emily E. Sharpe, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04462107
org study id: 19-012077
nct id: NCT04462107
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to describe how patients recover after scheduled C-section
      for the first 3 months.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
time frame: Baseline
description: EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
time frame: post partum=24 hours
description: EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
time frame: 48 hours post partum
description: EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
time frame: 1 week post partum
description: EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
time frame: 3 weeks post partum
description: EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
time frame: 6 weeks post partum
description: EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.
measure: Correlation between postpartum ObsQOR-10 and EQ-5D
time frame: 3 months post partum
description: EQ-5D describes current health for mobility, self-care, usual activities, pain, anxiety and on a scale of 0-100 to indicate current health status with 0 being the worst imaginable health and 100 being the best health imaginable. The ObsQOR-10 uses a scale of 0-10 with 0 being none and 10 being the worst imaginable, scoring pain, nausea, dizziness, shivering, comfort level, mobilization, holding baby, feeding baby, personal care, and feeling in control. r cesarean delivery and at 6 weeks post partum.
measure: To determine change in pain levels post C-section using the Visual Analog Scale (VAS)
time frame: Baseline, 24 hour, 48 hour, 1 week, 3 weeks, 6 weeks, 12 weeks, and 3 months
description: Describes pain from no pain at all to the worst pain imaginable using a 100mm horizontal line
measure: Compare opioid consumption post partum
time frame: 24 hours, 48 hours, 1 week, 3 weeks, 6 weeks, and 3months post partum
description: Compare opioid consumption post partum
measure: Compare non-maternal reasons for delayed hospital discharge
time frame: Hospital discharge, approximately 3 days
description: Document non-maternal reasons for delayed hospital discharge such as NICU admission of neonate, neonatal IV antibiotics, delay in transportation, delay from pediatric team.
measure: Compare frequency of activities of daily living
time frame: Baseline
description: Activities of daily living are routine activities people do everyday without assistance including eating, bathing, getting dressed, toileting, cooking, cleaning, driving, shopping. Subject will report these activities as not done yet, done once, once/week, do most days, do every day
measure: Compare frequency of activities of daily living
time frame: 6 weeks
description: Activities of daily living are routine activities people do everyday without assistance including eating, bathing, getting dressed, toileting, cooking, cleaning, driving, shopping. Subject will report these activities as not done yet, done once, once/week, do most days, do every day
measure: Compare Edinburgh Postnatal Depression Scale
time frame: 6 weeks
description: Edinburgh Postnatal Depression Scale is a 10 item questionnaire to identify women who have postpartum depression
measure: Compare a modified recovery after delivery questionnaire
time frame: 6 weeks
description: 9 questions that ask the mother about feeding baby, sleep, fatigue, bonding, parenting, and social functioning
arm group label: Surveys
description: All participants will complete questionnaires at several time points, ranging from baseline to 3 months post partum.
intervention type: Other
intervention name: Surveys
description: All participants will complete surveys that range in time from baseline to 3 months post partum.
arm group label: Surveys
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Women whom are pregnant and will have a scheduled C-section to deliver infant
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emily E Sharpe, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Emily E. Sharpe, M.D.
investigator title: Principal Investigator