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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:
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pillow and Wedge | No Intervention | Receiving standard care for positioning during labor using pillows and wedges | |
| Peanut Labor Ball | Experimental | Use of the peanut labor ball within 30 minutes after epidural placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut Labor Ball | Device | Peanut Labor Ball |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delivery Rate | Rate of patients who deliver by cesarean section | .5-72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | thirty minutes after epidural given to birth of baby |
| Measure | Description | Time Frame |
|---|---|---|
| Third and Fourth Degree Lacerations | Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery | within the last 15-30 minutes of birth |
Inclusion Criteria:
Gestation: 37 0/7weeks- 41 6/7weeks -early, full, and late term gestations (ACOG, 2013).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Evans, RN | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan TriHealth Hosptial | Cincinnati | Ohio | 45220 | United States |
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204 patients were enrolled between 5/22/2014 and 12/23/2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Pillow and Wedge | Receiving standard care for positioning during labor using pillows and wedges |
| FG001 | Peanut Labor Ball | Use of the peanut labor ball within 30 minutes after epidural placement Peanut Labor Ball: Peanut Labor Ball |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pillow and Wedge | Receiving standard care for positioning during labor using pillows and wedges |
| BG001 | Peanut Labor Ball | Use of the peanut labor ball within 30 minutes after epidural placement Peanut Labor Ball: Peanut Labor Ball |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delivery Rate | Rate of patients who deliver by cesarean section | Posted | Number | participants | .5-72 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pillow and Wedge | Receiving standard care for positioning during labor using pillows and wedges |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nurse Researcher | TriHealth | 513-569-6191 | Rachel_Baker2@trihealth.com |
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| did not use peanut ball as instructed |
|
| face presentation so she was ineligible |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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 | Included participants with vaginal delivery only | Posted | Mean | Standard Deviation | minutes | thirty minutes after epidural given to birth of baby |
|
|
|
| Other Pre-specified | Third and Fourth Degree Lacerations | Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery | participants with vaginal delivery only | Posted | Count of Participants | Participants | within the last 15-30 minutes of birth |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Peanut Labor Ball | Use of the peanut labor ball within 30 minutes after epidural placement Peanut Labor Ball: Peanut Labor Ball | 0 | 91 | 0 | 91 |
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