<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/NCT02999919</url>
  </required_header>
  <id_info>
    <org_study_id>16214662/050.01.04/87</org_study_id>
    <nct_id>NCT02999919</nct_id>
  </id_info>
  <brief_title>Body Mass Index and Post-dural Puncture Headache</brief_title>
  <official_title>The Relationship Between Body Mass Index and Post-dural Puncture Headache in Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress,&#xD;
      dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery.&#xD;
      Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced&#xD;
      cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this&#xD;
      study investigated the influence of body mass index (BMI) on PDPH in elective caesarean&#xD;
      section patients in whom 27G spinal needles were used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study included 420 women with American Society of Anesthesiology physical status I-II who&#xD;
      underwent elective caesarean section under spinal anesthesia. The patients with a BMI less&#xD;
      than 30 were accepted as normal weight (Group I) and those with a BMI above 30 were accepted&#xD;
      as obese (Group II). Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or&#xD;
      L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine intrathecally. The&#xD;
      patients were questioned regarding headache and low back pain 6, 12, 24, and 48 hours after&#xD;
      the procedure, and by phone calls on days 3 and 7.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>influence of body mass index (BMI) on PDPH in elective caesarean section patients</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">420</enrollment>
  <condition>This Study Investigated the Influence of Body Mass Index (BMI) on PDPH in Elective Caesarean Section Patients in Whom 27G Spinal Needles Were Used</condition>
  <arm_group>
    <arm_group_label>BMI ≥ 30</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BMI ≥ 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI &lt; 30</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BMI &lt;30</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spinal anesthesia</intervention_name>
    <description>12.5 mg hyperbaric bupivacaine intrathecally following a successful dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space in the sitting position</description>
    <arm_group_label>BMI &lt; 30</arm_group_label>
    <arm_group_label>BMI ≥ 30</arm_group_label>
    <other_name>bupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (ASA) physical status I-II who underwent elective caesarean section under SA. Women age&#xD;
        18-40 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Who had undergone lumbar disc or vertebra surgery, had chronic low back pain or&#xD;
             headache, had contraindications for neuro-axial block, and emergency patients.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakarya University</investigator_affiliation>
    <investigator_full_name>Serbülent Gökhan BEYAZ</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Dural Puncture Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT02999919
org study id: 16214662/050.01.04/87
nct id: NCT02999919
lead sponsor: 
has dmc: No
Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress,
      dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery.
      Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced
      cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this
      study investigated the influence of body mass index (BMI) on PDPH in elective caesarean
      section patients in whom 27G spinal needles were used.
The study included 420 women with American Society of Anesthesiology physical status I-II who
      underwent elective caesarean section under spinal anesthesia. The patients with a BMI less
      than 30 were accepted as normal weight (Group I) and those with a BMI above 30 were accepted
      as obese (Group II). Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or
      L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine intrathecally. The
      patients were questioned regarding headache and low back pain 6, 12, 24, and 48 hours after
      the procedure, and by phone calls on days 3 and 7.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Investigator, Outcomes Assessor)
measure: influence of body mass index (BMI) on PDPH in elective caesarean section patients
time frame: one year
arm group label: BMI ≥ 30
arm group type: Active Comparator
description: BMI ≥ 30
arm group label: BMI < 30
arm group type: Active Comparator
description: BMI <30
intervention type: Procedure
intervention name: spinal anesthesia
description: 12.5 mg hyperbaric bupivacaine intrathecally following a successful dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space in the sitting position
arm group label: BMI < 30
arm group label: BMI ≥ 30
other name: bupivacaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Sakarya University
investigator full name: Serbülent Gökhan BEYAZ
investigator title: associate professor
mesh term: Post-Dural Puncture Headache
mesh term: Headache
mesh term: Bupivacaine
sharing ipd: No