<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/NCT02237092</url>
  </required_header>
  <id_info>
    <org_study_id>TR-1</org_study_id>
    <nct_id>NCT02237092</nct_id>
  </id_info>
  <brief_title>Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia</brief_title>
  <acronym>IAPSB</acronym>
  <official_title>Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tver Regional Perinatal Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tver Regional Perinatal Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the&#xD;
      volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute&#xD;
      to the development of more high spinal block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the&#xD;
      likelihood of developing a high-level (=&gt;Th4) sensor block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Level of Intra-abdominal Pressure (IAP)</measure>
    <time_frame>Before spinal anesthesia, average 10 minutes.</time_frame>
    <description>Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Classification Grade of Intra-abdominal Hypertension (IAH)</measure>
    <time_frame>Before spinal anesthesia, average 10 minutes.</time_frame>
    <description>Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Obesity and IAP</measure>
    <time_frame>Before spinal anesthesia, average 10 minutes.</time_frame>
    <description>Effect of obesity on the level of IAP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of Sensory Blocks</measure>
    <time_frame>After spinal anesthesia, average 20 minutes.</time_frame>
    <description>Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Level of IAP</measure>
    <time_frame>After spinal anesthesia, average 20 minutes.</time_frame>
    <description>The level of IAP in obstetric patients in the groups with high ( =&gt; Th4) and low (&lt; = Th5) blocks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Pregnants With Blocks = &gt; Th4 With IAP Higher or Less Than 16 mm Hg</measure>
    <time_frame>After spinal anesthesia, average 20 minutes.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Obstetric Anesthesia Problems</condition>
  <condition>High-Risk Pregnancy</condition>
  <arm_group>
    <arm_group_label>Measurement of IAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The data obtained are in inches of water column were translated in millimeters of mercury.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Measurement of IAP</intervention_name>
    <description>The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.</description>
    <arm_group_label>Measurement of IAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age 36 - 40 weeks&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
          -  Elective caesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestational age &lt;= 35 weeks&#xD;
&#xD;
          -  Twins pregnancies&#xD;
&#xD;
          -  Disease the cardiovascular system (hypertension, etc.)&#xD;
&#xD;
          -  Non-elective caesarean section&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandr Ronenson, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tver Regional Perinatal Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergei Sitkin, DMedSc</last_name>
    <role>Study Director</role>
    <affiliation>Tver State Medical Academy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tver Regional Perinatal Center</name>
      <address>
        <city>Tver</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <results_reference>
    <citation>S. Sitkin, A. Ronenson, J. Savelieva, M. Cherdyntsev. Prediction of high level spinal block in caesarean section. Regional Anesthesia and Pain Medicine. - 2012. - Volume 37. - Sup 1 5. - p. 183.</citation>
  </results_reference>
  <results_reference>
    <citation>Sitkin, S.; Ronenson, A.; Wagle, S.; Saveleva, J. Effect of intra-abdominal pressure of pregnancy for the development of spinal block for cesarean section: 11AP1-10. European Journal of Anaesthesiology. - 2013 - Volume 30. - Sup 51. - p. 167-168.</citation>
  </results_reference>
  <results_reference>
    <citation>Sitkin S., Ronenson A.M., Savelieva J.V., Wagle S. Influence of intra-abdominal pressure (iap) and body mass index (bmi) in pregnancy on the development of spinal block for cesarean section. Regional Anesthesia and Pain Medicine, Volume 38, Number 5, Supplement 1 5, September-October. - 2013. - p. 179</citation>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <results_first_submitted>September 10, 2014</results_first_submitted>
  <results_first_submitted_qc>September 30, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 2, 2014</results_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Gestational age 36 - 40 weeks, Singleton pregnancies, Elective caesarean section</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Measurement of IAP</title>
          <description>The data obtained are in inches of water column were translated in millimeters of mercury.&#xD;
Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Pregnant planned for cesarean section</population>
      <group_list>
        <group group_id="B1">
          <title>Measurement of IAP</title>
          <description>Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="196"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.5" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Pregnant women</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.9" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.8" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Abdominal circumference</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105.1" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Level of Intra-abdominal Pressure (IAP)</title>
        <description>Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.</description>
        <time_frame>Before spinal anesthesia, average 10 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intra-abdominal Pressure (IAP) in Pregnant Women</title>
            <description>Average IAP in pregnant women</description>
          </group>
        </group_list>
        <measure>
          <title>The Level of Intra-abdominal Pressure (IAP)</title>
          <description>Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.</description>
          <units>mm Hg</units>
          <param>Median</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.33" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Classification Grade of Intra-abdominal Hypertension (IAH)</title>
        <description>Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)</description>
        <time_frame>Before spinal anesthesia, average 10 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physiological Norm</title>
            <description>(≤11,99 mm Hg)</description>
          </group>
          <group group_id="O2">
            <title>Grade I</title>
            <description>(12 - 15.99 mm Hg)</description>
          </group>
          <group group_id="O3">
            <title>Grade II</title>
            <description>(16 - 20.99 mm Hg)</description>
          </group>
          <group group_id="O4">
            <title>Grade III</title>
            <description>(21 - 25.99 mm Hg)</description>
          </group>
        </group_list>
        <measure>
          <title>Classification Grade of Intra-abdominal Hypertension (IAH)</title>
          <description>Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)</description>
          <units>mm Hg</units>
          <param>Median</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="96"/>
                <count group_id="O3" value="79"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.60" spread="0.09"/>
                    <measurement group_id="O2" value="14.11" spread="0.10"/>
                    <measurement group_id="O3" value="17.43" spread="0.14"/>
                    <measurement group_id="O4" value="21.56" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Sensory Blocks</title>
        <description>Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra</description>
        <time_frame>After spinal anesthesia, average 20 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Level of Sensory Block =&gt; Th4 (Spinal Anesthesia)</title>
            <description>Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia</description>
          </group>
          <group group_id="O2">
            <title>Level of Sensory Block &lt; = Th5 (Spinal Anesthesia)</title>
            <description>Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Sensory Blocks</title>
          <description>Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra</description>
          <units>Block level level of thoracic vertebrae</units>
          <param>Median</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="0.1"/>
                    <measurement group_id="O2" value="5.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Obesity and IAP</title>
        <description>Effect of obesity on the level of IAP</description>
        <time_frame>Before spinal anesthesia, average 10 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Obesity</title>
            <description>BMI &lt; = 29.99</description>
          </group>
          <group group_id="O2">
            <title>Obesity</title>
            <description>BMI = &gt; 30.00</description>
          </group>
        </group_list>
        <measure>
          <title>Obesity and IAP</title>
          <description>Effect of obesity on the level of IAP</description>
          <units>mm Hg</units>
          <param>Median</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.61" spread="0.20"/>
                    <measurement group_id="O2" value="16.06" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Level of IAP</title>
        <description>The level of IAP in obstetric patients in the groups with high ( =&gt; Th4) and low (&lt; = Th5) blocks</description>
        <time_frame>After spinal anesthesia, average 20 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Level of Sensory Block =&gt; Th4 (Spinal Anesthesia)</title>
            <description>Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia</description>
          </group>
          <group group_id="O2">
            <title>Level of Sensory Block &lt; = Th5 (Spinal Anesthesia)</title>
            <description>Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>The Level of IAP</title>
          <description>The level of IAP in obstetric patients in the groups with high ( =&gt; Th4) and low (&lt; = Th5) blocks</description>
          <units>mm Hg</units>
          <param>Median</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5" spread="0.3"/>
                    <measurement group_id="O2" value="14.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.02</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Pregnants With Blocks = &gt; Th4 With IAP Higher or Less Than 16 mm Hg</title>
        <time_frame>After spinal anesthesia, average 20 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Level of IAP &lt; 16 mm Hg</title>
            <description>number of pregnant women with Level of IAP &lt; 16 mm Hg</description>
          </group>
          <group group_id="O2">
            <title>Level of IAP = &gt; 16 mm Hg</title>
            <description>number of pregnant women with Level of IAP = &gt; 16 mm Hg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Pregnants With Blocks = &gt; Th4 With IAP Higher or Less Than 16 mm Hg</title>
          <units>Number of pregnants with Blocks = &gt; Th4</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>NNT</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.05</ci_lower_limit>
            <ci_upper_limit>2.58</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the operation, an average of 30 minutes</time_frame>
      <desc>Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure</desc>
      <group_list>
        <group group_id="E1">
          <title>Level of Sensory Block =&gt; Th4 (Spinal Anesthesia)</title>
          <description>Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure</description>
        </group>
        <group group_id="E2">
          <title>Level of Sensory Block &lt; = Th5 (Spinal Anesthesia)</title>
          <description>Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Hypotension</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure</description>
                <counts group_id="E1" events="23" subjects_affected="23" subjects_at_risk="62"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>General anesthesia</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Changing the type of anesthesia</sub_title>
                <description>Changing the type of anesthesia to General anesthesia</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Alexandr Ronenson</name_or_title>
      <organization>Tver Regional Perinatal Center</organization>
      <phone>011-7-4822-776213</phone>
      <email>ronensonam@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02237092
org study id: TR-1
nct id: NCT02237092
lead sponsor: 
has dmc: Yes
It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the
      volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute
      to the development of more high spinal block.
There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the
      likelihood of developing a high-level (=>Th4) sensor block.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The Level of Intra-abdominal Pressure (IAP)
time frame: Before spinal anesthesia, average 10 minutes.
description: Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.
measure: Classification Grade of Intra-abdominal Hypertension (IAH)
time frame: Before spinal anesthesia, average 10 minutes.
description: Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)
measure: Obesity and IAP
time frame: Before spinal anesthesia, average 10 minutes.
description: Effect of obesity on the level of IAP
measure: Level of Sensory Blocks
time frame: After spinal anesthesia, average 20 minutes.
description: Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra
measure: The Level of IAP
time frame: After spinal anesthesia, average 20 minutes.
description: The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks
measure: Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg
time frame: After spinal anesthesia, average 20 minutes.
arm group label: Measurement of IAP
arm group type: Experimental
description: The data obtained are in inches of water column were translated in millimeters of mercury.
intervention type: Procedure
intervention name: Measurement of IAP
description: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.
arm group label: Measurement of IAP
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandr Ronenson, PhD student
role: Principal Investigator
affiliation: Tver Regional Perinatal Center
last name: Sergei Sitkin, DMedSc
role: Study Director
affiliation: Tver State Medical Academy
facility: 
country: Russian Federation
citation: S. Sitkin, A. Ronenson, J. Savelieva, M. Cherdyntsev. Prediction of high level spinal block in caesarean section. Regional Anesthesia and Pain Medicine. - 2012. - Volume 37. - Sup 1 5. - p. 183.
citation: Sitkin, S.; Ronenson, A.; Wagle, S.; Saveleva, J. Effect of intra-abdominal pressure of pregnancy for the development of spinal block for cesarean section: 11AP1-10. European Journal of Anaesthesiology. - 2013 - Volume 30. - Sup 51. - p. 167-168.
citation: Sitkin S., Ronenson A.M., Savelieva J.V., Wagle S. Influence of intra-abdominal pressure (iap) and body mass index (bmi) in pregnancy on the development of spinal block for cesarean section. Regional Anesthesia and Pain Medicine, Volume 38, Number 5, Supplement 1 5, September-October. - 2013. - p. 179
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 