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Use of Peanut Labor Ball Following Epidural Anesthesia
NCT02190591 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Peanut Labor Ball
Study Locations (1)
Ohio
- Good Samaritan TriHealth Hosptial — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02190591
The ClinicalTrials.gov registry entry for NCT02190591 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TriHealth, which has 20 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which Peanut Labor Ball is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02190591 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02190591 about?
NCT02190591 is a clinical study titled "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...
What is the current status of trial NCT02190591?
This trial is currently completed. It is a NA study. The enrollment target is 204 participants. The study started on 2014-05. Estimated completion is 2015-08.
What conditions does trial NCT02190591 study?
This clinical trial studies the following conditions: Pregnancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02190591?
The interventions under investigation include: Peanut Labor Ball (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02190591?
This trial is sponsored by TriHealth, which has 20 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02190591 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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