Use of Peanut Labor Ball Following Epidural Anesthesia
Completed · Not applicable
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT02190591
- Run by
- TriHealth Inc.
- People needed
- 204
- Starts
- 2014-05-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2017-04-06
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Good Samaritan TriHealth Hosptial — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.