Use of Peanut Labor Ball Following Epidural Anesthesia

NCT ID: NCT02190591

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-08-31

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

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pillow and Wedge

Receiving standard care for positioning during labor using pillows and wedges

Group Type: NO_INTERVENTION

No interventions assigned to this group

Peanut Labor Ball

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

Group Type: EXPERIMENTAL

Peanut Labor Ball

Intervention Type: DEVICE

Peanut Labor Ball

Interventions

Peanut Labor Ball

Peanut Labor Ball

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Rachel Baker

Nurse Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Evans, RN

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

Good Samaritan TriHealth Hosptial

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

14034-14-027

Identifier Type: -

Identifier Source: org_study_id