Use of Peanut Labor Ball Following Epidural Anesthesia

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190591
• Other study ID #: 14034-14-027
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: September 30, 2016
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2016
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Peanut Labor Ball
Peanut Labor Ball

Locations

Country	Name	City	State
United States	Good Samaritan TriHealth Hosptial	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Third and Fourth Degree Laceration Rates	Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery	within the last 15-30 minutes of birth	No
Primary	Delivery Rate	Rate of patients who deliver by cesarean section or vaginal delivery while using the peanut labor ball vs. those using the standard pillow and wedge method	.5-72 hours	No
Secondary	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 and progression through second stage labor	thirty minutes after epidural given to birth of baby	No