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OpenTrials
Completed

NCT Number: NCT02190591

Use of Peanut Labor Ball Following Epidural Anesthesia

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.

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan TriHealth Hosptial

Cincinnati, Ohio, 45220, United States

About this study

See above

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peanut Labor Ball

Device

Peanut Labor Ball

Primary outcomes

  1. Delivery Rate

    Time frame: .5-72 hours

    Rate of patients who deliver by cesarean section

Secondary outcomes

  1. Dilation to Second Stage Labor

    Time frame: thirty 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

Other outcomes

  1. Third and Fourth Degree Lacerations

    Time frame: within the last 15-30 minutes of birth

    Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 15, 2014
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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