<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/NCT02190591</url>
  </required_header>
  <id_info>
    <org_study_id>14034-14-027</org_study_id>
    <nct_id>NCT02190591</nct_id>
  </id_info>
  <brief_title>Use of Peanut Labor Ball Following Epidural Anesthesia</brief_title>
  <official_title>Use of Peanut Labor Ball for Pelvic Positioning for Nulliparous Patients Following Epidural</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after&#xD;
      epidural anesthesia in patients who have never given birth. The study will measure the impact&#xD;
      on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or&#xD;
      forceps use), and third or fourth degree laceration rates. This study will determine the&#xD;
      impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and&#xD;
      one with traditional wedge and pillow positioning. If benefits related to use of the PLB can&#xD;
      be demonstrated, it is our intention that each labor room will be stocked with a PBL for use&#xD;
      as standard of care.&#xD;
&#xD;
      This study will test the following hypotheses:&#xD;
&#xD;
        1. The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal&#xD;
           delivery rate in low risk nulliparous patients who receive epidural anesthesia compared&#xD;
           to similar cohort using traditional wedge and pillow positioning.&#xD;
&#xD;
        2. Using the PLB will impact the amount of time from epidural placement to complete&#xD;
           dilation and the time of second stage of labor, when compared with the control cohort.&#xD;
&#xD;
        3. Use of the PLB will impact the third and fourth degree laceration rates when compared&#xD;
           with the control cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      See above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Delivery Rate</measure>
    <time_frame>.5-72 hours</time_frame>
    <description>Rate of patients who deliver by cesarean section</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dilation to Second Stage Labor</measure>
    <time_frame>thirty minutes after epidural given to birth of baby</time_frame>
    <description>Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Third and Fourth Degree Lacerations</measure>
    <time_frame>within the last 15-30 minutes of birth</time_frame>
    <description>Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pillow and Wedge</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receiving standard care for positioning during labor using pillows and wedges</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peanut Labor Ball</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the peanut labor ball within 30 minutes after epidural placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Peanut Labor Ball</intervention_name>
    <description>Peanut Labor Ball</description>
    <arm_group_label>Peanut Labor Ball</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any nulliparous woman age ≥18 years presenting in labor (or for induction of labor)&#xD;
             with:&#xD;
&#xD;
        Gestation: 37 0/7weeks- 41 6/7weeks -early, full, and late term gestations (ACOG, 2013).&#xD;
&#xD;
          -  Single gestation&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Plans to deliver with epidural anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A complication of pregnancy at the time of admission (including known fetal anomalies&#xD;
             or placental anomalies)&#xD;
&#xD;
          -  Any muscular or skeletal limitations of the patient that does not allow for&#xD;
             positioning with the peanut labor ball (PLB)&#xD;
&#xD;
          -  An inability to speak or understand English language&#xD;
&#xD;
          -  Preterm gestation: &lt;36 6/7 weeks or Post-term &gt;42 0/7weeks&#xD;
&#xD;
          -  A multiple gestation&#xD;
&#xD;
          -  Non-vertex presentation&#xD;
&#xD;
          -  Diabetes including Gestational Diabetes Mellitus (GDM)&#xD;
&#xD;
          -  Order for magnesium sulfate infusion&#xD;
&#xD;
          -  Plan for delivery without epidural&#xD;
&#xD;
          -  Planned cesarean delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Evans, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Good Samaritan TriHealth Hosptial</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>May 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>October 3, 2016</results_first_submitted>
  <results_first_submitted_qc>October 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 25, 2016</results_first_posted>
  <last_update_submitted>March 8, 2017</last_update_submitted>
  <last_update_submitted_qc>March 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>TriHealth Inc.</investigator_affiliation>
    <investigator_full_name>Rachel Baker</investigator_full_name>
    <investigator_title>Nurse Researcher</investigator_title>
  </responsible_party>
  <keyword>epidural</keyword>
  <keyword>pregnant</keyword>
  <keyword>Cesarean Section</keyword>
  <keyword>forceps</keyword>
  <keyword>vaginal</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>204 patients were enrolled between 5/22/2014 and 12/23/2014</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pillow and Wedge</title>
          <description>Receiving standard care for positioning during labor using pillows and wedges</description>
        </group>
        <group group_id="P2">
          <title>Peanut Labor Ball</title>
          <description>Use of the peanut labor ball within 30 minutes after epidural placement&#xD;
Peanut Labor Ball: Peanut Labor Ball</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not use peanut ball as instructed</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>face presentation so she was ineligible</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pillow and Wedge</title>
          <description>Receiving standard care for positioning during labor using pillows and wedges</description>
        </group>
        <group group_id="B2">
          <title>Peanut Labor Ball</title>
          <description>Use of the peanut labor ball within 30 minutes after epidural placement&#xD;
Peanut Labor Ball: Peanut Labor Ball</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="91"/>
            <count group_id="B3" value="191"/>
          </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="26.5" spread="4.7"/>
                    <measurement group_id="B2" value="26.7" spread="4.9"/>
                    <measurement group_id="B3" value="26.6" spread="4.8"/>
                  </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="91"/>
                    <measurement group_id="B3" value="191"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Delivery Rate</title>
        <description>Rate of patients who deliver by cesarean section</description>
        <time_frame>.5-72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pillow and Wedge</title>
            <description>Receiving standard care for positioning during labor using pillows and wedges</description>
          </group>
          <group group_id="O2">
            <title>Peanut Labor Ball</title>
            <description>Use of the peanut labor ball within 30 minutes after epidural placement&#xD;
Peanut Labor Ball: Peanut Labor Ball</description>
          </group>
        </group_list>
        <measure>
          <title>Delivery Rate</title>
          <description>Rate of patients who deliver by cesarean section</description>
          <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="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dilation to Second Stage Labor</title>
        <description>Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation</description>
        <time_frame>thirty minutes after epidural given to birth of baby</time_frame>
        <population>Included participants with vaginal delivery only</population>
        <group_list>
          <group group_id="O1">
            <title>Pillow and Wedge</title>
            <description>Receiving standard care for positioning during labor using pillows and wedges</description>
          </group>
          <group group_id="O2">
            <title>Peanut Labor Ball</title>
            <description>Use of the peanut labor ball within 30 minutes after epidural placement&#xD;
Peanut Labor Ball: Peanut Labor Ball</description>
          </group>
        </group_list>
        <measure>
          <title>Dilation to Second Stage Labor</title>
          <description>Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation</description>
          <population>Included participants with vaginal delivery only</population>
          <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="69"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="322.7" spread="174"/>
                    <measurement group_id="O2" value="331.3" spread="187.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Third and Fourth Degree Lacerations</title>
        <description>Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery</description>
        <time_frame>within the last 15-30 minutes of birth</time_frame>
        <population>participants with vaginal delivery only</population>
        <group_list>
          <group group_id="O1">
            <title>Pillow and Wedge</title>
            <description>Receiving standard care for positioning during labor using pillows and wedges</description>
          </group>
          <group group_id="O2">
            <title>Peanut Labor Ball</title>
            <description>Use of the peanut labor ball within 30 minutes after epidural placement&#xD;
Peanut Labor Ball: Peanut Labor Ball</description>
          </group>
        </group_list>
        <measure>
          <title>Third and Fourth Degree Lacerations</title>
          <description>Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery</description>
          <population>participants with vaginal delivery only</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Pillow and Wedge</title>
          <description>Receiving standard care for positioning during labor using pillows and wedges</description>
        </group>
        <group group_id="E2">
          <title>Peanut Labor Ball</title>
          <description>Use of the peanut labor ball within 30 minutes after epidural placement&#xD;
Peanut Labor Ball: Peanut Labor Ball</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="91"/>
              </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="91"/>
              </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>Nurse Researcher</name_or_title>
      <organization>TriHealth</organization>
      <phone>513-569-6191</phone>
      <email>Rachel_Baker2@trihealth.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/NCT02190591
org study id: 14034-14-027
nct id: NCT02190591
lead sponsor: 
has dmc: Yes
The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after
      epidural anesthesia in patients who have never given birth. The study will measure the impact
      on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or
      forceps use), and third or fourth degree laceration rates. This study will determine the
      impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and
      one with traditional wedge and pillow positioning. If benefits related to use of the PLB can
      be demonstrated, it is our intention that each labor room will be stocked with a PBL for use
      as standard of care.

      This study will test the following hypotheses:

        1. The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal
           delivery rate in low risk nulliparous patients who receive epidural anesthesia compared
           to similar cohort using traditional wedge and pillow positioning.

        2. Using the PLB will impact the amount of time from epidural placement to complete
           dilation and the time of second stage of labor, when compared with the control cohort.

        3. Use of the PLB will impact the third and fourth degree laceration rates when compared
           with the control cohort.
See above
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Delivery Rate
time frame: .5-72 hours
description: Rate of patients who deliver by cesarean section
measure: Dilation to Second Stage Labor
time frame: thirty minutes after epidural given to birth of baby
description: Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation
measure: Third and Fourth Degree Lacerations
time frame: within the last 15-30 minutes of birth
description: Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery
arm group label: Pillow and Wedge
arm group type: No Intervention
description: Receiving standard care for positioning during labor using pillows and wedges
arm group label: Peanut Labor Ball
arm group type: Experimental
description: Use of the peanut labor ball within 30 minutes after epidural placement
intervention type: Device
intervention name: Peanut Labor Ball
description: Peanut Labor Ball
arm group label: Peanut Labor Ball
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Evans, RN
role: Principal Investigator
affiliation: TriHealth Inc.
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: TriHealth Inc.
investigator full name: Rachel Baker
investigator title: Nurse Researcher
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 