N/A
N=204
Use of Peanut Labor Ball Following Epidural Anesthesia
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02190591 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Delivery Rate — 31; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peanut Labor Ball (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- TriHealth Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delivery Rate |
31; 21 | — |
| SECONDARY Dilation to Second Stage Labor |
322.7; 331.3 | — |
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.
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: 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
Data sourced from ClinicalTrials.gov (NCT02190591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.