NCT02190591

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. 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. 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. 3.Use of the PLB will impact the third and fourth degree laceration rates when compared with the control cohort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 25, 2016

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

May 16, 2014

Results QC Date

October 3, 2016

Last Update Submit

March 8, 2017

Conditions

Pregnancy

Keywords

epiduralpregnantCesarean Sectionforcepsvaginal

Outcome Measures

Primary Outcomes (1)

  • Delivery Rate

    Rate of patients who deliver by cesarean section

    .5-72 hours

Secondary Outcomes (1)

  • Dilation to Second Stage Labor

    thirty minutes after epidural given to birth of baby

Other Outcomes (1)

  • Third and Fourth Degree Lacerations

    within the last 15-30 minutes of birth

Study Arms (2)

Pillow and Wedge

NO INTERVENTION

Receiving standard care for positioning during labor using pillows and wedges

Peanut Labor Ball

EXPERIMENTAL

Use of the peanut labor ball within 30 minutes after epidural placement

Device: Peanut Labor Ball

Interventions

Peanut Labor BallDEVICE

Peanut Labor Ball

Peanut Labor Ball

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan TriHealth Hosptial

Cincinnati, Ohio, 45220, United States

Location

Results Point of Contact

Title
Nurse Researcher
Organization
TriHealth
Rachel_Baker2@trihealth.com
513-569-6191

Study Officials

  • Sarah Evans, RN

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Researcher

Study Record Dates

First Submitted

May 16, 2014

First Posted

July 15, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

April 6, 2017

Results First Posted

November 25, 2016

Record last verified: 2017-03

Locations

US(1)