<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/NCT03772886</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0613</org_study_id>
    <nct_id>NCT03772886</nct_id>
  </id_info>
  <brief_title>Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball</brief_title>
  <official_title>Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Geisinger Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine if using the peanut ball during labor reduces the cesarean&#xD;
      delivery rate when compared to normal intrapartum management (no peanut ball) in the obese&#xD;
      patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently at Geisinger Medical Center Danville, use of the peanut ball is at the discretion&#xD;
      of attending or resident physicians, or obstetric nurses on the Labor and delivery team for&#xD;
      the day. Despite the common use of this labor adjuvant tool, a well-designed prospective&#xD;
      study is necessary to investigate if the peanut ball provides any benefit during the labor&#xD;
      process for the obese gravida. If this simple tool is shown to reduce the rate of cesarean&#xD;
      delivery, then hospital protocols could be changed to ensure its use during labor. This has&#xD;
      the potential to decrease the rate of cesarean delivery in the most vulnerable patient&#xD;
      population. The investigators propose a randomized controlled trial (RCT) to determine if&#xD;
      using the peanut ball during labor provides a reduction in the cesarean delivery rate in the&#xD;
      obese patient population. The investigators will compare cesarean delivery rates in patients&#xD;
      using the peanut ball to patients receiving routine intrapartum management without the use of&#xD;
      the peanut ball. Singleton pregnancies complicated by obesity, defined by pre-pregnancy BMI &gt;&#xD;
      30kg/m2, will be included.&#xD;
&#xD;
      Study participants will be randomized to one of the two study arms. The peanut ball arm (also&#xD;
      referred to as study arm 1) will be managed according to the parameters specified for use of&#xD;
      the peanut ball. The participants in the Control arm (also referred to as study arm 2) will&#xD;
      be managed according to the standard intrapartum management as defined by Geisinger's Labor &amp;&#xD;
      Delivery protocol and per the OB providers. The objective of the study is to determine if use&#xD;
      of the peanut ball during labor reduces the cesarean delivery rate in the obese patient&#xD;
      population. Secondary outcomes of interest include rate of cervical dilation, rate of&#xD;
      operative deliveries, fetal position (occiput anterior vs. occiput posterior) at complete&#xD;
      dilation (10 cm), and patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to complete enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">September 9, 2019</start_date>
  <completion_date type="Actual">June 9, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cesarean Delivery Rate</measure>
    <time_frame>Delivery</time_frame>
    <description>Number of vaginal deliveries vs. Number of cesarean deliveries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Cervical Dilation</measure>
    <time_frame>Randomization until complete dilation (10cm)</time_frame>
    <description>The average amount of cervical dilation (cm) per hour compared between the two groups (peanut ball vs. no peanut ball).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of Vaginal Delivery</measure>
    <time_frame>Delivery</time_frame>
    <description>Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal Position</measure>
    <time_frame>Complete Dilation (10cm)</time_frame>
    <description>Occiput anterior versus occiput posterior versus occiput transverse</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Satisfaction Survey</measure>
    <time_frame>Postpartum Day One</time_frame>
    <description>Evaluating overall patient satisfaction during labor course</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Obesity</condition>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Peanut Ball Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants randomized to the Peanut Ball Arm will have the peanut ball placed during labor. Study participants will be required to use the peanut ball for a minimum of 30 minutes of each hour until they reach complete dilation. Peanut ball use time will be noted in the patient's chart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Study participants randomized to the Control Arm will labor without the peanut ball.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Peanut Ball</intervention_name>
    <description>A peanut shaped exercise ball.</description>
    <arm_group_label>Peanut Ball Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted for delivery&#xD;
&#xD;
          -  Pre-pregnancy BMI &gt; 30kg/m2&#xD;
&#xD;
          -  Planned vaginal delivery at Geisinger Medical Center (GMC)&#xD;
&#xD;
          -  Gestational age &gt; 37 weeks 0 days&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Cephalic presentation&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-pregnancy BMI &lt; 30kg/m2&#xD;
&#xD;
          -  Contraindication to vaginal delivery&#xD;
&#xD;
          -  Planned cesarean delivery (i.e., an elective primary or repeat cesarean delivery)&#xD;
&#xD;
          -  Gestational age &lt; 37 weeks 0 days&#xD;
&#xD;
          -  Multifetal gestation&#xD;
&#xD;
          -  Intrauterine fetal demise&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Greater than 9cm at the time of randomization&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Awathif D Mackeen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Geisinger Clinic</investigator_affiliation>
    <investigator_full_name>Awathif Dhanya Mackeen</investigator_full_name>
    <investigator_title>Division of Maternal-Fetal Medicine</investigator_title>
  </responsible_party>
  <keyword>Peanut Ball</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03772886
org study id: 2018-0613
nct id: NCT03772886
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to determine if using the peanut ball during labor reduces the cesarean
      delivery rate when compared to normal intrapartum management (no peanut ball) in the obese
      patient population.
Currently at Geisinger Medical Center Danville, use of the peanut ball is at the discretion
      of attending or resident physicians, or obstetric nurses on the Labor and delivery team for
      the day. Despite the common use of this labor adjuvant tool, a well-designed prospective
      study is necessary to investigate if the peanut ball provides any benefit during the labor
      process for the obese gravida. If this simple tool is shown to reduce the rate of cesarean
      delivery, then hospital protocols could be changed to ensure its use during labor. This has
      the potential to decrease the rate of cesarean delivery in the most vulnerable patient
      population. The investigators propose a randomized controlled trial (RCT) to determine if
      using the peanut ball during labor provides a reduction in the cesarean delivery rate in the
      obese patient population. The investigators will compare cesarean delivery rates in patients
      using the peanut ball to patients receiving routine intrapartum management without the use of
      the peanut ball. Singleton pregnancies complicated by obesity, defined by pre-pregnancy BMI >
      30kg/m2, will be included.

      Study participants will be randomized to one of the two study arms. The peanut ball arm (also
      referred to as study arm 1) will be managed according to the parameters specified for use of
      the peanut ball. The participants in the Control arm (also referred to as study arm 2) will
      be managed according to the standard intrapartum management as defined by Geisinger's Labor &
      Delivery protocol and per the OB providers. The objective of the study is to determine if use
      of the peanut ball during labor reduces the cesarean delivery rate in the obese patient
      population. Secondary outcomes of interest include rate of cervical dilation, rate of
      operative deliveries, fetal position (occiput anterior vs. occiput posterior) at complete
      dilation (10 cm), and patient satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cesarean Delivery Rate
time frame: Delivery
description: Number of vaginal deliveries vs. Number of cesarean deliveries
measure: Rate of Cervical Dilation
time frame: Randomization until complete dilation (10cm)
description: The average amount of cervical dilation (cm) per hour compared between the two groups (peanut ball vs. no peanut ball).
measure: Type of Vaginal Delivery
time frame: Delivery
description: Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries.
measure: Fetal Position
time frame: Complete Dilation (10cm)
description: Occiput anterior versus occiput posterior versus occiput transverse
measure: Patient Satisfaction Survey
time frame: Postpartum Day One
description: Evaluating overall patient satisfaction during labor course
arm group label: Peanut Ball Arm
arm group type: Experimental
description: Study participants randomized to the Peanut Ball Arm will have the peanut ball placed during labor. Study participants will be required to use the peanut ball for a minimum of 30 minutes of each hour until they reach complete dilation. Peanut ball use time will be noted in the patient's chart.
arm group label: Control Arm
arm group type: No Intervention
description: Study participants randomized to the Control Arm will labor without the peanut ball.
intervention type: Device
intervention name: Peanut Ball
description: A peanut shaped exercise ball.
arm group label: Peanut Ball Arm
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Awathif D Mackeen, MD
role: Principal Investigator
affiliation: Geisinger Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Geisinger Clinic
investigator full name: Awathif Dhanya Mackeen
investigator title: Division of Maternal-Fetal Medicine