Pregnancy
Conditions
Keywords
epidural, pregnant, Cesarean Section, forceps, vaginal
Brief 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.
Detailed description
See above
Interventions
DEVICEPeanut Labor Ball
Peanut Labor Ball
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery Rate | .5-72 hours | Rate of patients who deliver by cesarean section |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dilation to Second Stage Labor | 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
| Measure | Time frame | Description |
|---|---|---|
| Third and Fourth Degree Lacerations | within the last 15-30 minutes of birth | Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery |
Countries
United States
Participant flow
Recruitment details
204 patients were enrolled between 5/22/2014 and 12/23/2014
Participants by arm
| Arm | Count |
|---|---|
| Pillow and Wedge Receiving standard care for positioning during labor using pillows and wedges | 100 |
| Peanut Labor Ball Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball | 91 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not use peanut ball as instructed | 0 | 2 |
| Overall Study | face presentation so she was ineligible | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 8 |
Baseline characteristics
| Characteristic | Pillow and Wedge | Peanut Labor Ball | Total |
|---|---|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 4.7 | 26.7 years STANDARD_DEVIATION 4.9 | 26.6 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment United States | 100 participants | 91 participants | 191 participants |
| Sex: Female, Male Female | 100 Participants | 91 Participants | 191 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 91 |
| serious Total, serious adverse events | 0 / 100 | 0 / 91 |
Outcome results
Primary
Delivery Rate
Rate of patients who deliver by cesarean section
Time frame: .5-72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pillow and Wedge | Delivery Rate | 31 participants |
| Peanut Labor Ball | Delivery Rate | 21 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
Time frame: thirty minutes after epidural given to birth of baby
Population: Included participants with vaginal delivery only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pillow and Wedge | Dilation to Second Stage Labor | 322.7 minutes | Standard Deviation 174 |
| Peanut Labor Ball | Dilation to Second Stage Labor | 331.3 minutes | Standard Deviation 187.1 |
Other Pre-specified
Third and Fourth Degree Lacerations
Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery
Time frame: within the last 15-30 minutes of birth
Population: participants with vaginal delivery only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pillow and Wedge | Third and Fourth Degree Lacerations | 5 Participants |
| Peanut Labor Ball | Third and Fourth Degree Lacerations | 2 Participants |