Use of Peanut Labor Ball Following Epidural Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Peanut Labor Ball

Detailed Description

See above

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan TriHealth Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Third and Fourth Degree Lacerations	Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery	within the last 15-30 minutes of birth

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Sarah Evans, RN, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: pregnant; epidural; Cesarean Section; vaginal; forceps
• Other Study ID Numbers: 14034-14-027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No