Use of Peanut Labor Ball Following Epidural Anesthesia

Study Overview
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Brief Summary
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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: 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. 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. Use of the PLB will impact the third and fourth degree laceration rates when compared with the control cohort.

Detailed Description
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See above

Official Title
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Use of Peanut Labor Ball for Pelvic Positioning for Nulliparous Patients Following Epidural

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Peanut Labor Ball


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any nulliparous woman age ≥18 years presenting in labor (or for induction of labor) with: Gestation: 37 0/7weeks- 41 6/7weeks -early, full, and late term gestations (ACOG, 2013). Single gestation Vertex presentation Plans to deliver with epidural anesthesia Exclusion Criteria: A complication of pregnancy at the time of admission (including known fetal anomalies or placental anomalies) Any muscular or skeletal limitations of the patient that does not allow for positioning with the peanut labor ball (PLB) An inability to speak or understand English language Preterm gestation: <36 6/7 weeks or Post-term >42 0/7weeks A multiple gestation Non-vertex presentation Diabetes including Gestational Diabetes Mellitus (GDM) Order for magnesium sulfate infusion Plan for delivery without epidural Planned cesarean delivery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pillow and Wedge<br>Receiving standard care for positioning during labor using pillows and wedges | |
| Experimental: Peanut Labor Ball<br>Use of the peanut labor ball within 30 minutes after epidural placement | Device: Peanut Labor Ball<br>* Peanut Labor Ball<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Rate | Rate of patients who deliver by cesarean section | .5-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dilation to Second Stage Labor | Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation | thirty minutes after epidural given to birth of baby | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural, pregnant, Cesarean Section, forceps, vaginal