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/NCT05983029</url>
    </required_header>
    <id_info>
      <org_study_id>291462</org_study_id>
      <nct_id>NCT05983029</nct_id>
    </id_info>
    <brief_title>Determination of Utility of Intergluteal Cleft as Landmark for Neuraxial Midline in Obstetrics</brief_title>
    <acronym>CLEFT</acronym>
    <official_title>Determination of the Utility of the Intergluteal Cleft as a Landmark for nEuraxial Midline identiFication in obsteTric Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guy's and St Thomas' NHS Foundation Trust</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>
        Our aim is to investigate whether a novel landmark, the groove between the buttocks or the&#xD;
        intergluteal cleft, can facilitate the identification of the neuraxial midline in obstetric&#xD;
        patients when compared to ultrasound as the reference standard for the determination of this&#xD;
        midline&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Determine if the intergluteal cleft, when compared to ultrasound as the reference standard,&#xD;
        can be used to identify the neuraxial midline in obstetric patients&#xD;
  &#xD;
        Difference in horizontal distance between the vertical lines of the intergluteal cleft and&#xD;
        the neuraxial midline, the latter measured with ultrasound&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Horizontal distance between intergluteal cleft and neuraxial midline</measure>
      <time_frame>12 months</time_frame>
      <description>One horizontal distance and hence one primary outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in horizontal distance stratified by body mass index</measure>
      <time_frame>12 months</time_frame>
      <description>Variation for BMI and recorded data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in horizontal distance stratified by presence of pre-eclampsia</measure>
      <time_frame>12 months</time_frame>
      <description>Variation for pre-ecalmpsia and recorded data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in horizontal distance stratified by presence of pregnancy induced hypertension</measure>
      <time_frame>12 months</time_frame>
      <description>Variation for pregnancy induced hypertension a and recorded data</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">99</enrollment>
    <condition>Obstetric Anesthesia Problems</condition>
    <arm_group>
      <arm_group_label>Study Group</arm_group_label>
      <description>Each patient will be requested to adopt a standardised upright position. First, two of the investigators will use a spirit level ruler and ink pen to agree upon and visibly mark the horizontal intercristal line on the back of the patient. Second, investigator B will leave the room, and investigator A will make a vertical mark with an ultraviolet pen denoting the intersection of the inferior aspect of the intergluteal cleft and the horizontal intercristal line. Third, investigator A will then leave the room, and investigator B will return to the room to make a vertical mark with an ink pen representing the intersection of the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line. After these two vertical marks have been made at the level of the intercristal line, the horizontal distance between them will be measured in mm by these same two investigators</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Intergluteal Cleft</intervention_name>
      <description>Marking of intersection between inferior aspect of the intergluteal cleft and the horizontal intercristal line</description>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Neuraxial Midline</intervention_name>
      <description>Marking of intersection between the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line</description>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Horizontal Distance between Vertical Markings</intervention_name>
      <description>The horizontal distance between these two vertical marks will be measured at the level of the intercristal line</description>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Gestation of 37 weeks or above&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Acute or chronic confusional state&#xD;
  &#xD;
            -  Allergy to ultrasound gel&#xD;
  &#xD;
            -  Positive for COVID-19 and/or presence of symptoms consistent with SARS-Cov-2, such as&#xD;
               anosmia, cough or fever&#xD;
  &#xD;
            -  History of previous surgery to the spine&#xD;
  &#xD;
            -  Scoliosis&#xD;
  &#xD;
            -  Unable to speak and/or understand English&#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>Gill Arbane, BSc</last_name>
      <role>Study Chair</role>
      <affiliation>Guys' &amp; St Thomas' NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Neel Desai, FRCA</last_name>
      <phone>02071887188</phone>
      <email>Neel.Desai@gstt.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marwa Salman, FRCA</last_name>
      <phone>02071887188</phone>
      <email>Marwa.Salman@gstt.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Guy's Hospital, Great Maze Pond</name>
        <address>
          <city>London</city>
          <zip>SE1 9RT</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Gill Arbane</last_name>
        <phone>0207 188 8070</phone>
        <email>gill.arbane@gstt.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Marwa Salman, FRCA</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Neel Desai, FRCA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>November 22, 2022</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05983029
  org study id: 291462
  nct id: NCT05983029
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our aim is to investigate whether a novel landmark, the groove between the buttocks or the
        intergluteal cleft, can facilitate the identification of the neuraxial midline in obstetric
        patients when compared to ultrasound as the reference standard for the determination of this
        midline
  Determine if the intergluteal cleft, when compared to ultrasound as the reference standard,
        can be used to identify the neuraxial midline in obstetric patients
  
        Difference in horizontal distance between the vertical lines of the intergluteal cleft and
        the neuraxial midline, the latter measured with ultrasound
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Horizontal distance between intergluteal cleft and neuraxial midline
  time frame: 12 months
  description: One horizontal distance and hence one primary outcome
  measure: Difference in horizontal distance stratified by body mass index
  time frame: 12 months
  description: Variation for BMI and recorded data
  measure: Difference in horizontal distance stratified by presence of pre-eclampsia
  time frame: 12 months
  description: Variation for pre-ecalmpsia and recorded data
  measure: Difference in horizontal distance stratified by presence of pregnancy induced hypertension
  time frame: 12 months
  description: Variation for pregnancy induced hypertension a and recorded data
  arm group label: Study Group
  description: Each patient will be requested to adopt a standardised upright position. First, two of the investigators will use a spirit level ruler and ink pen to agree upon and visibly mark the horizontal intercristal line on the back of the patient. Second, investigator B will leave the room, and investigator A will make a vertical mark with an ultraviolet pen denoting the intersection of the inferior aspect of the intergluteal cleft and the horizontal intercristal line. Third, investigator A will then leave the room, and investigator B will return to the room to make a vertical mark with an ink pen representing the intersection of the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line. After these two vertical marks have been made at the level of the intercristal line, the horizontal distance between them will be measured in mm by these same two investigators
  intervention type: Diagnostic Test
  intervention name: Intergluteal Cleft
  description: Marking of intersection between inferior aspect of the intergluteal cleft and the horizontal intercristal line
  arm group label: Study Group
  intervention type: Diagnostic Test
  intervention name: Neuraxial Midline
  description: Marking of intersection between the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line
  arm group label: Study Group
  intervention type: Diagnostic Test
  intervention name: Horizontal Distance between Vertical Markings
  description: The horizontal distance between these two vertical marks will be measured at the level of the intercristal line
  arm group label: Study Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gill Arbane, BSc
  role: Study Chair
  affiliation: Guys' & St Thomas' NHS Foundation Trust
  last name: Neel Desai, FRCA
  phone: 02071887188
  email: Neel.Desai@gstt.nhs.uk
  last name: Marwa Salman, FRCA
  phone: 02071887188
  email: Marwa.Salman@gstt.nhs.uk
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No