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Use of Peanut Labor Ball Following Epidural Anesthesia

NCT02190591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2017-04-06

Study results available
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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.

Conditions

  • Pregnancy

Interventions

DEVICE

Peanut Labor Ball

Peanut Labor Ball

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • Sarah Evans, RN · TriHealth Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-12-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02190591 on ClinicalTrials.gov