Trial Outcomes & Findings for Use of Peanut Labor Ball Following Epidural Anesthesia (NCT NCT02190591)
NCT ID: NCT02190591
Last Updated: 2017-04-06
Results Overview
Rate of patients who deliver by cesarean section
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
.5-72 hours
Results posted on
2017-04-06
Participant Flow
204 patients were enrolled between 5/22/2014 and 12/23/2014
Participant milestones
| Measure |
Pillow and Wedge
Receiving standard care for positioning during labor using pillows and wedges
|
Peanut Labor Ball
Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
100
|
91
|
|
Overall Study
NOT COMPLETED
|
2
|
11
|
Reasons for withdrawal
| Measure |
Pillow and Wedge
Receiving standard care for positioning during labor using pillows and wedges
|
Peanut Labor Ball
Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
8
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
did not use peanut ball as instructed
|
0
|
2
|
|
Overall Study
face presentation so she was ineligible
|
0
|
1
|
Baseline Characteristics
Use of Peanut Labor Ball Following Epidural Anesthesia
Baseline characteristics by cohort
| Measure |
Pillow and Wedge
n=100 Participants
Receiving standard care for positioning during labor using pillows and wedges
|
Peanut Labor Ball
n=91 Participants
Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.5 years
STANDARD_DEVIATION 4.7 • n=93 Participants
|
26.7 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
26.6 years
STANDARD_DEVIATION 4.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
191 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=93 Participants
|
91 participants
n=4 Participants
|
191 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: .5-72 hoursRate of patients who deliver by cesarean section
Outcome measures
| Measure |
Pillow and Wedge
n=100 Participants
Receiving standard care for positioning during labor using pillows and wedges
|
Peanut Labor Ball
n=91 Participants
Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball
|
|---|---|---|
|
Delivery Rate
|
31 participants
|
21 participants
|
SECONDARY outcome
Timeframe: thirty minutes after epidural given to birth of babyPopulation: Included participants with vaginal delivery only
Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation
Outcome measures
| Measure |
Pillow and Wedge
n=69 Participants
Receiving standard care for positioning during labor using pillows and wedges
|
Peanut Labor Ball
n=70 Participants
Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball
|
|---|---|---|
|
Dilation to Second Stage Labor
|
322.7 minutes
Standard Deviation 174
|
331.3 minutes
Standard Deviation 187.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within the last 15-30 minutes of birthPopulation: participants with vaginal delivery only
Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery
Outcome measures
| Measure |
Pillow and Wedge
n=69 Participants
Receiving standard care for positioning during labor using pillows and wedges
|
Peanut Labor Ball
n=70 Participants
Use of the peanut labor ball within 30 minutes after epidural placement
Peanut Labor Ball: Peanut Labor Ball
|
|---|---|---|
|
Third and Fourth Degree Lacerations
|
5 Participants
|
2 Participants
|
Adverse Events
Pillow and Wedge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peanut Labor Ball
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place