MedPath

Use of Peanut Labor Ball Following Epidural Anesthesia

Not Applicable
Completed
Conditions
Pregnancy
Interventions
Device: Peanut Labor Ball
Registration Number
NCT02190591
Lead Sponsor
TriHealth Inc.
Brief Summary

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.

Detailed Description

See above

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
204
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Peanut Labor BallPeanut Labor BallUse of the peanut labor ball within 30 minutes after epidural placement
Primary Outcome Measures
NameTimeMethod
Delivery Rate.5-72 hours

Rate of patients who deliver by cesarean section

Secondary Outcome Measures
NameTimeMethod
Dilation to Second Stage Laborthirty minutes after epidural given to birth of baby

Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation

Trial Locations

Locations (1)

Good Samaritan TriHealth Hosptial

🇺🇸

Cincinnati, Ohio, United States

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