<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/NCT02229513</url>
  </required_header>
  <id_info>
    <org_study_id>013-035</org_study_id>
    <nct_id>NCT02229513</nct_id>
  </id_info>
  <brief_title>Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage</brief_title>
  <official_title>Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to demonstrate whether cooling the uterine smooth muscle during&#xD;
      cesarean section (following delivery of the fetus) will promote better uterine contraction&#xD;
      and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer&#xD;
      hysterectomies following cesarean section. The investigators suspect that it may.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design:&#xD;
&#xD;
      Patients will be randomly assigned to either the study group or the control group. Patients&#xD;
      may receive regional (epidural or spinal/epidural) or general anesthesia.Initially, the&#xD;
      investigators plan to enroll 200 subjects, 100 to the study group and 100 to the control&#xD;
      group.&#xD;
&#xD;
      Following delivery of the fetus, patients in the study group also will have Pitocin®&#xD;
      administered to them according to the usual protocol.Immediately following delivery of the&#xD;
      fetus the uterus will be externalized in the usual fashion and the body of the uterus&#xD;
      cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in&#xD;
      sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30&#xD;
      degrees Fahrenheit. The skin of the abdomen will be draped to prevent contact with the cold&#xD;
      towels. Additional uterotonic medications may be given at the discretion of the attending&#xD;
      obstetrician.&#xD;
&#xD;
      Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at&#xD;
      the discretion of the attending obstetrician until the hysterotomy is closed and the uterus&#xD;
      is replaced into the patient's abdomen. The surface temperature of the uterus will be&#xD;
      measured using an infrared thermometer prior to replacing the uterus into the abdomen.&#xD;
&#xD;
      Two surgical suction canisters will be available. Immediately after delivery of the fetus and&#xD;
      prior to delivery of the placenta, the amniotic fluid and blood on the surgical field will be&#xD;
      aspirated into the first canister. The second suction canister will be used to aspirate blood&#xD;
      and fluid until the conclusion of the operation.&#xD;
&#xD;
      At the conclusion of the surgery blood loss will be calculated by measuring the content of&#xD;
      blood in the second canister minus the amount of irrigation fluid used, and by weighing the&#xD;
      surgical sponges. Average blood loss during cesarean sections has previously been reported as&#xD;
      500 to 1000 cc.&#xD;
&#xD;
      The duration of cooling the uterus will be recorded.&#xD;
&#xD;
      Use and amount of uterotonic medications also will be recorded.&#xD;
&#xD;
      During the surgery the patient's vital signs will be monitored in the usual fashion.&#xD;
      Particular attention will be paid to a change in her temperature. Warmed blankets and forced&#xD;
      air warming blankets will be used to maintain normothermia, if required.&#xD;
&#xD;
      At the conclusion of the study the amount of blood loss between the control and study groups,&#xD;
      and the amount of uterotonic drugs will be calculated and compared. The number of patients in&#xD;
      each group who require additional surgeries, e.g. hysterectomy or D&amp;C, will be monitored.&#xD;
      Pre-op and post-op hemograms will be compared if obtained at the discretion of the attending&#xD;
      obstetrician. Blood product administration will be recorded.&#xD;
&#xD;
      Determination of an ideal temperature of cooling towels is not an objective of the study.&#xD;
      We're asking a qualitative question, not a quantitative question at this time.&#xD;
&#xD;
      Study Rationale: The uterus is a smooth muscle whose contraction is modulated most directly&#xD;
      by intrinsic or extrinsic oxytocin. During pregnancy the spiral arteries within the uterus&#xD;
      and beneath the placenta enlarge to provide adequate perfusion to the placenta. After&#xD;
      separation of the placenta the uterine smooth muscle cells contract in a pincer-like action&#xD;
      to pinch the spiral arteries closed. When uterine contraction is inadequate (approximately&#xD;
      4-6% of normal pregnancies) the spiral arteries continue to bleed. If not addressed the&#xD;
      bleeding can be excessive, even leading to maternal death. Approximately 5-8 out of 1,000&#xD;
      cesarean sections require hysterectomy to control bleeding.&#xD;
&#xD;
      Release of calcium ions from sarcoplasmic reticulum stores is the immediate initiator of&#xD;
      contraction, and calcium's diffusion from the muscle filaments and re-uptake by the&#xD;
      sarcoplasmic reticulum results in relaxation of contraction. In some smooth muscles cold&#xD;
      enhances contraction; perhaps by slowing the re-uptake of calcium. When the usual&#xD;
      pharmacologic agents fail to induce adequate contraction of the uterine smooth muscle, the&#xD;
      investigators suspect that application of cold may.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Loss</measure>
    <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
    <description>At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pre- vs Post-operative Hematocrit</measure>
    <time_frame>48 hours post operative period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Uterotonic Medications</measure>
    <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Extra Oxytocin</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Methergine</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Hemabate</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Cytotec</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bakri Bulb Placement</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions</measure>
    <time_frame>Intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirement of Blood Products</measure>
    <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Blood Loss Greater Than 1000 cc</measure>
    <time_frame>Intra-op, Post-Op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirement of Cesarean Hysterectomy</measure>
    <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Temperature</measure>
    <time_frame>Pre-op, Intra-op, Post-Op</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Total Time Uterus Wrapped</measure>
    <time_frame>During hysterotomy repair</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Uterine Temperature After Wrap Removed</measure>
    <time_frame>Immediately following hysterotomy repair</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <condition>Uterine Atony</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Normal cesarean technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Uterine Cooling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Uterine Cooling</intervention_name>
    <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
    <arm_group_label>Uterine Cooling</arm_group_label>
    <other_name>Hush Slush Machine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant adult women of any gravidity, and gestational duration who present for&#xD;
             cesarean section at Baylor University Medical Center in Dallas and who have given&#xD;
             informed consent to be in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who refuse to be in the study, and women who are unable to consent due to&#xD;
             emergent nature of the cesarean section will be excluded. Women who are unable to&#xD;
             understand the nature of the study due to mental illness, mental retardation, medical&#xD;
             condition, or other communication barrier will be excluded.&#xD;
&#xD;
          -  Inability to exteriorize the uterus during c-section.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janice L Mitchell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor University Medical Center Resident</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>October 28, 2015</results_first_submitted>
  <results_first_submitted_qc>December 10, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 13, 2016</results_first_posted>
  <last_update_submitted>January 17, 2018</last_update_submitted>
  <last_update_submitted_qc>January 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postpartum hemorrhage</keyword>
  <keyword>uterine atony</keyword>
  <keyword>cesarean section</keyword>
  <keyword>cesarean hysterectomy</keyword>
  <keyword>acute blood loss anemia</keyword>
  <keyword>uterotonics</keyword>
  <keyword>obstetric hemorrhage</keyword>
  <keyword>severe hemorrhage</keyword>
  <keyword>blood transfusion</keyword>
  <keyword>obstetric emergencies</keyword>
  <keyword>obstetrics</keyword>
  <keyword>massive hemorrhage</keyword>
  <keyword>hemorrhage</keyword>
  <keyword>uterine cooling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Uterine Inertia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Normal cesarean technique.</description>
        </group>
        <group group_id="P2">
          <title>Uterine Cooling</title>
          <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Normal cesarean technique.</description>
        </group>
        <group group_id="B2">
          <title>Uterine Cooling</title>
          <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.1" spread="4.8"/>
                    <measurement group_id="B2" value="31.7" spread="5.1"/>
                    <measurement group_id="B3" value="30.9" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height (ft)</title>
          <units>feet</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.4" spread="0.2"/>
                    <measurement group_id="B2" value="5.4" spread="0.3"/>
                    <measurement group_id="B3" value="5.4" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (lbs)</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="200" spread="49"/>
                    <measurement group_id="B2" value="187" spread="39"/>
                    <measurement group_id="B3" value="194" spread="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gravidity</title>
          <units>pregnancies</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.5" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="B2" value="2.4" lower_limit="1" upper_limit="9"/>
                    <measurement group_id="B3" value="2.5" lower_limit="1" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>births</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.0" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="B2" value="1.0" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B3" value="1.0" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational Age (wks)</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.5" spread="2.2"/>
                    <measurement group_id="B2" value="38.0" spread="4.2"/>
                    <measurement group_id="B3" value="38.3" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fetal Presentation</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Cephalic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breech</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transverse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oblique</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Compound</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Multiple Gestations</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fetal Weight (g)</title>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3504" spread="852"/>
                    <measurement group_id="B2" value="3471" spread="822"/>
                    <measurement group_id="B3" value="3488" spread="835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous Cesareans</title>
          <units>cesareans</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.8" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B2" value="0.7" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="0.8" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Trial of Labor</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-op Epidural</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Loss</title>
        <description>At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.</description>
        <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Loss</title>
          <description>At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.</description>
          <units>cc</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intraoperative blood loss</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="616" spread="411"/>
                    <measurement group_id="O2" value="418" spread="317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PACU blood loss</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141" spread="199"/>
                    <measurement group_id="O2" value="106" spread="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total blood loss</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="756" spread="462"/>
                    <measurement group_id="O2" value="536" spread="429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pre- vs Post-operative Hematocrit</title>
        <time_frame>48 hours post operative period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pre- vs Post-operative Hematocrit</title>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="3.6"/>
                    <measurement group_id="O2" value="4.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Uterotonic Medications</title>
        <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Uterotonic Medications</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Extra Oxytocin</title>
        <time_frame>Intraoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Extra Oxytocin</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Temperature</title>
        <time_frame>Pre-op, Intra-op, Post-Op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Temperature</title>
          <units>degrees Fahrenheit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.3" spread="0.4"/>
                    <measurement group_id="O2" value="98.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intra-operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" spread="1.0"/>
                    <measurement group_id="O2" value="97.9" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-operative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" spread="0.4"/>
                    <measurement group_id="O2" value="97.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Total Time Uterus Wrapped</title>
        <time_frame>During hysterotomy repair</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Time Uterus Wrapped</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="4.3"/>
                    <measurement group_id="O2" value="9.4" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Uterine Temperature After Wrap Removed</title>
        <time_frame>Immediately following hysterotomy repair</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Uterine Temperature After Wrap Removed</title>
          <units>degrees Fahrenheit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.3" spread="3.0"/>
                    <measurement group_id="O2" value="75.5" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Methergine</title>
        <time_frame>Intraoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Methergine</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Hemabate</title>
        <time_frame>Intraoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Hemabate</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Cytotec</title>
        <time_frame>Intraoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Cytotec</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bakri Bulb Placement</title>
        <time_frame>Intraoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Bakri Bulb Placement</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions</title>
        <time_frame>Intraoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Requirement of Blood Products</title>
        <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Requirement of Blood Products</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Blood Loss Greater Than 1000 cc</title>
        <time_frame>Intra-op, Post-Op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Blood Loss Greater Than 1000 cc</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Requirement of Cesarean Hysterectomy</title>
        <time_frame>During surgery and in the PACU (approximately 3 total hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal cesarean technique.</description>
          </group>
          <group group_id="O2">
            <title>Uterine Cooling</title>
            <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
          </group>
        </group_list>
        <measure>
          <title>Requirement of Cesarean Hysterectomy</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 4 days</time_frame>
      <desc>All patients received routine post-operative and postpartum care. Their vitals were monitored for evidence of hypothermia or infection, and they received both routine post-operative day 1 labs, including a CBC, as well as follow labs as indicated. They were monitored for evidence of delayed postpartum hemorrhage.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Normal cesarean technique.</description>
        </group>
        <group group_id="E2">
          <title>Uterine Cooling</title>
          <description>Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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. Janice Mitchell, PI</name_or_title>
      <organization>Baylor University Medical Center</organization>
      <phone>713-705-6240</phone>
      <email>janicemitchellmd@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/NCT02229513
org study id: 013-035
nct id: NCT02229513
lead sponsor: 
has dmc: No
The objective of the study is to demonstrate whether cooling the uterine smooth muscle during
      cesarean section (following delivery of the fetus) will promote better uterine contraction
      and involution resulting in lower blood loss, use of fewer uterotonic medications, and fewer
      hysterectomies following cesarean section. The investigators suspect that it may.
Study Design:

      Patients will be randomly assigned to either the study group or the control group. Patients
      may receive regional (epidural or spinal/epidural) or general anesthesia.Initially, the
      investigators plan to enroll 200 subjects, 100 to the study group and 100 to the control
      group.

      Following delivery of the fetus, patients in the study group also will have Pitocin®
      administered to them according to the usual protocol.Immediately following delivery of the
      fetus the uterus will be externalized in the usual fashion and the body of the uterus
      cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in
      sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30
      degrees Fahrenheit. The skin of the abdomen will be draped to prevent contact with the cold
      towels. Additional uterotonic medications may be given at the discretion of the attending
      obstetrician.

      Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at
      the discretion of the attending obstetrician until the hysterotomy is closed and the uterus
      is replaced into the patient's abdomen. The surface temperature of the uterus will be
      measured using an infrared thermometer prior to replacing the uterus into the abdomen.

      Two surgical suction canisters will be available. Immediately after delivery of the fetus and
      prior to delivery of the placenta, the amniotic fluid and blood on the surgical field will be
      aspirated into the first canister. The second suction canister will be used to aspirate blood
      and fluid until the conclusion of the operation.

      At the conclusion of the surgery blood loss will be calculated by measuring the content of
      blood in the second canister minus the amount of irrigation fluid used, and by weighing the
      surgical sponges. Average blood loss during cesarean sections has previously been reported as
      500 to 1000 cc.

      The duration of cooling the uterus will be recorded.

      Use and amount of uterotonic medications also will be recorded.

      During the surgery the patient's vital signs will be monitored in the usual fashion.
      Particular attention will be paid to a change in her temperature. Warmed blankets and forced
      air warming blankets will be used to maintain normothermia, if required.

      At the conclusion of the study the amount of blood loss between the control and study groups,
      and the amount of uterotonic drugs will be calculated and compared. The number of patients in
      each group who require additional surgeries, e.g. hysterectomy or D&C, will be monitored.
      Pre-op and post-op hemograms will be compared if obtained at the discretion of the attending
      obstetrician. Blood product administration will be recorded.

      Determination of an ideal temperature of cooling towels is not an objective of the study.
      We're asking a qualitative question, not a quantitative question at this time.

      Study Rationale: The uterus is a smooth muscle whose contraction is modulated most directly
      by intrinsic or extrinsic oxytocin. During pregnancy the spiral arteries within the uterus
      and beneath the placenta enlarge to provide adequate perfusion to the placenta. After
      separation of the placenta the uterine smooth muscle cells contract in a pincer-like action
      to pinch the spiral arteries closed. When uterine contraction is inadequate (approximately
      4-6% of normal pregnancies) the spiral arteries continue to bleed. If not addressed the
      bleeding can be excessive, even leading to maternal death. Approximately 5-8 out of 1,000
      cesarean sections require hysterectomy to control bleeding.

      Release of calcium ions from sarcoplasmic reticulum stores is the immediate initiator of
      contraction, and calcium's diffusion from the muscle filaments and re-uptake by the
      sarcoplasmic reticulum results in relaxation of contraction. In some smooth muscles cold
      enhances contraction; perhaps by slowing the re-uptake of calcium. When the usual
      pharmacologic agents fail to induce adequate contraction of the uterine smooth muscle, the
      investigators suspect that application of cold may.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Blood Loss
time frame: During surgery and in the PACU (approximately 3 total hours)
description: At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.
measure: Change in Pre- vs Post-operative Hematocrit
time frame: 48 hours post operative period
measure: Use of Uterotonic Medications
time frame: During surgery and in the PACU (approximately 3 total hours)
measure: Use of Extra Oxytocin
time frame: Intraoperatively
measure: Use of Methergine
time frame: Intraoperatively
measure: Use of Hemabate
time frame: Intraoperatively
measure: Use of Cytotec
time frame: Intraoperatively
measure: Bakri Bulb Placement
time frame: Intraoperatively
measure: Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions
time frame: Intraoperatively
measure: Requirement of Blood Products
time frame: During surgery and in the PACU (approximately 3 total hours)
measure: Total Blood Loss Greater Than 1000 cc
time frame: Intra-op, Post-Op
measure: Requirement of Cesarean Hysterectomy
time frame: During surgery and in the PACU (approximately 3 total hours)
measure: Patient Temperature
time frame: Pre-op, Intra-op, Post-Op
measure: Total Time Uterus Wrapped
time frame: During hysterotomy repair
measure: Uterine Temperature After Wrap Removed
time frame: Immediately following hysterotomy repair
arm group label: Control
arm group type: No Intervention
description: Normal cesarean technique.
arm group label: Uterine Cooling
arm group type: Experimental
description: Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
intervention type: Procedure
intervention name: Uterine Cooling
description: Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
arm group label: Uterine Cooling
other name: Hush Slush Machine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janice L Mitchell, MD
role: Principal Investigator
affiliation: Baylor University Medical Center Resident
facility: 
country: United States
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Uterine Inertia
mesh term: Hemorrhage
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 