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/NCT06012747</url>
    </required_header>
    <id_info>
      <org_study_id>100</org_study_id>
      <nct_id>NCT06012747</nct_id>
    </id_info>
    <brief_title>Pain After Cesarean Section - A Danish Multicenter Cohort Study.</brief_title>
    <official_title>Pain After Cesarean Section - A Danish Multicenter Cohort Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nordsjaellands Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nordsjaellands Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study&#xD;
        from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and&#xD;
        found that 45% of 861 patients had experienced very severe pain during recovery.&#xD;
  &#xD;
        This result was surprisingly high but also unspecific. Therefore, the investigators aim to&#xD;
        investigate the intensity of pain experienced by patients at specific time intervals after&#xD;
        the cesarean section e.g., every 6th hour. Additionally, the investigators will examine&#xD;
        whether the pain has an impact on important functions for both the patients and the newborns,&#xD;
        as well as assess the overall morphine consumption.&#xD;
  &#xD;
        All Danish regions have approved the REDCap database as a secure way to collect and store&#xD;
        data. REDCap can also send encrypted links that can be converted into SMS messages sent to&#xD;
        the participants' mobile phones at fixed intervals, allowing participants to enter data&#xD;
        directly into the secure system. The investigators also aim to feasibility test the system.&#xD;
  &#xD;
        When a child is delivered by cesarean section, it is an expectation that the mother can take&#xD;
        care of herself and the baby a few hours after the surgery. However, severe pain can hinder&#xD;
        this. Therefore, it is important to investigate whether pain relief for our patients is&#xD;
        sufficient.&#xD;
  &#xD;
        Based on response rates and the frequency of outcomes, data from this observational study can&#xD;
        support the design of a future national multicenter randomized controlled trial (RCT) with a&#xD;
        focus on postoperative pain intervention. The incidences of binary outcome measures and&#xD;
        standard deviations of continuous outcome measures will support the sample size calculations&#xD;
        for our RCT.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10</measure>
      <time_frame>24 hours after cesarean section</time_frame>
      <description>Patient reported</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Composite outcome of self reported morphine side effects occurring within 24 hours For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.</measure>
      <time_frame>24 hours after cesarean section</time_frame>
      <description>consisting of either nausea, dizziness, itching, vomiting, or urinary retention.&#xD;
  Nausea, itching, and dizziness are recorded on a 4-point scale: None, mild, moderate, severe. Where moderate and severe are considered side effects.&#xD;
  For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Neonatal admission ,</measure>
      <time_frame>within 24 hours</time_frame>
      <description>yes/no</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>See protokol for the multible secondary and exploratory outcomes</measure>
      <time_frame>0-30 days</time_frame>
      <description>See protokol for the multible secondary and exploratory outcomes</description>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Pain</condition>
    <condition>Cesarean Section</condition>
    <condition>Recovery</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>The patients receive a questionnaire every 6 hours during the first 24 hours after their cesarean section, and again after 2, 7, and 30 days.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Danish patients &gt; 18 years old who undergo planned cesarean section under spinal anesthesia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria Patients who undergo planned cesarean section under spinal anesthesia.&#xD;
          Patients must be able to answer a Danish questionnaire via SMS on their phone and provide&#xD;
          consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Age &lt; 18 years&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Patricia Duch, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hillerod Hospital, Denmark</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Helene Nedergaard, MD, Ph.D</last_name>
      <role>Study Chair</role>
      <affiliation>Kolding Sygehus</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Patricia Duch, MD</last_name>
      <phone>0045 48292504</phone>
      <email>patricia.duch@regioh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Helene Nedergaard, MD</last_name>
      <phone>0045 76 36 20 00</phone>
      <email>helene.korvenius.nedergaard@rsyd.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Copenhagen University Hospital</name>
        <address>
          <city>Hillerød</city>
          <zip>3400</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <contact>
        <last_name>Patricia Duch, MD</last_name>
        <phone>48292504</phone>
        <email>patricia.duch@regionh.dk</email>
      </contact>
      <investigator>
        <last_name>Patricia Duch, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Nordsjaellands Hospital</investigator_affiliation>
      <investigator_full_name>Patricia Duch</investigator_full_name>
      <investigator_title>MD Patricia Duch</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Cesarean Section</keyword>
    <keyword>Recovery</keyword>
    <keyword>REDCap</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Each participating site has access to the data, which can be viewed by the project managers. Once all the data is collected, it will be anonymized and used for calculations. After the data is published, each participating site can have control over its own data but can only publish it with the permission of the project managers.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 11, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT06012747/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06012747
  org study id: 100
  nct id: NCT06012747
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study
        from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and
        found that 45% of 861 patients had experienced very severe pain during recovery.
  
        This result was surprisingly high but also unspecific. Therefore, the investigators aim to
        investigate the intensity of pain experienced by patients at specific time intervals after
        the cesarean section e.g., every 6th hour. Additionally, the investigators will examine
        whether the pain has an impact on important functions for both the patients and the newborns,
        as well as assess the overall morphine consumption.
  
        All Danish regions have approved the REDCap database as a secure way to collect and store
        data. REDCap can also send encrypted links that can be converted into SMS messages sent to
        the participants' mobile phones at fixed intervals, allowing participants to enter data
        directly into the secure system. The investigators also aim to feasibility test the system.
  
        When a child is delivered by cesarean section, it is an expectation that the mother can take
        care of herself and the baby a few hours after the surgery. However, severe pain can hinder
        this. Therefore, it is important to investigate whether pain relief for our patients is
        sufficient.
  
        Based on response rates and the frequency of outcomes, data from this observational study can
        support the design of a future national multicenter randomized controlled trial (RCT) with a
        focus on postoperative pain intervention. The incidences of binary outcome measures and
        standard deviations of continuous outcome measures will support the sample size calculations
        for our RCT.
  observational model: Cohort
  time perspective: Prospective
  measure: Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10
  time frame: 24 hours after cesarean section
  description: Patient reported
  measure: Composite outcome of self reported morphine side effects occurring within 24 hours For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.
  time frame: 24 hours after cesarean section
  description: consisting of either nausea, dizziness, itching, vomiting, or urinary retention.
  Nausea, itching, and dizziness are recorded on a 4-point scale: None, mild, moderate, severe. Where moderate and severe are considered side effects.
  For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.
  measure: Neonatal admission ,
  time frame: within 24 hours
  description: yes/no
  measure: See protokol for the multible secondary and exploratory outcomes
  time frame: 0-30 days
  description: See protokol for the multible secondary and exploratory outcomes
  intervention type: Other
  intervention name: Questionnaire
  description: The patients receive a questionnaire every 6 hours during the first 24 hours after their cesarean section, and again after 2, 7, and 30 days.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  last name: Patricia Duch, MD
  role: Principal Investigator
  affiliation: Hillerod Hospital, Denmark
  last name: Helene Nedergaard, MD, Ph.D
  role: Study Chair
  affiliation: Kolding Sygehus
  last name: Patricia Duch, MD
  phone: 0045 48292504
  email: patricia.duch@regioh.dk
  last name: Helene Nedergaard, MD
  phone: 0045 76 36 20 00
  email: helene.korvenius.nedergaard@rsyd.dk
  facility: 
  contact: 
  investigator: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Nordsjaellands Hospital
  investigator full name: Patricia Duch
  investigator title: MD Patricia Duch
  sharing ipd: Undecided
  ipd description: Each participating site has access to the data, which can be viewed by the project managers. Once all the data is collected, it will be anonymized and used for calculations. After the data is published, each participating site can have control over its own data but can only publish it with the permission of the project managers.
  provided document: 