Trial Outcomes & Findings for Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia? (NCT NCT02539563)
NCT ID: NCT02539563
Last Updated: 2022-03-18
Results Overview
time in minutes will be calculated from epidural catheter insertion until delivery
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
up to 24 hours
Results posted on
2022-03-18
Participant Flow
Participant milestones
| Measure |
Peanut Ball
the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized
|
no Peanut Ball
the peanut shaped birthing ball will not be utilized during labor
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
56
|
|
Overall Study
COMPLETED
|
39
|
42
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
analysis performed on those completing study only
Baseline characteristics by cohort
| Measure |
Peanut Ball
n=39 Participants
the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized
|
no Peanut Ball
n=42 Participants
the peanut shaped birthing ball will not be utilized during labor
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=39 Participants
|
42 participants
n=41 Participants
|
81 participants
n=35 Participants
|
|
Height
|
165.1 centimeters
STANDARD_DEVIATION 5.1 • n=39 Participants • analysis performed on those completing study only
|
161.3 centimeters
STANDARD_DEVIATION 7.6 • n=41 Participants • analysis performed on those completing study only
|
163.2 centimeters
STANDARD_DEVIATION 6.4 • n=35 Participants • analysis performed on those completing study only
|
|
Weight
|
91.4 kilograms
STANDARD_DEVIATION 21.4 • n=39 Participants • analysis performed on those completing study only
|
90.5 kilograms
STANDARD_DEVIATION 22.7 • n=41 Participants • analysis performed on those completing study only
|
90.9 kilograms
STANDARD_DEVIATION 21.9 • n=35 Participants • analysis performed on those completing study only
|
|
Gestational Age
|
39.5 weeks
STANDARD_DEVIATION 1.23 • n=39 Participants
|
39.6 weeks
STANDARD_DEVIATION 1.31 • n=41 Participants
|
39.55 weeks
STANDARD_DEVIATION 1.27 • n=35 Participants
|
|
Oxytocin Augmentation
|
24 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
52 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: up to 24 hourstime in minutes will be calculated from epidural catheter insertion until delivery
Outcome measures
| Measure |
Peanut Ball
n=39 Participants
the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized
|
no Peanut Ball
n=42 Participants
the peanut shaped birthing ball will not be utilized during labor
|
|---|---|---|
|
Length of Labor
|
387 minutes
Standard Deviation 256
|
441 minutes
Standard Deviation 269
|
SECONDARY outcome
Timeframe: length of labor, up to 24 hours11-point scale of 0=not satisfied up to 10=most satisfied of all
Outcome measures
| Measure |
Peanut Ball
n=39 Participants
the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized
|
no Peanut Ball
n=42 Participants
the peanut shaped birthing ball will not be utilized during labor
|
|---|---|---|
|
Maternal Satisfaction
|
8.86 units on a scale
Standard Deviation 2.01
|
7.88 units on a scale
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: up to 24 hoursthe number of subjects who had to had a cesarean delivery
Outcome measures
| Measure |
Peanut Ball
n=39 Participants
the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized
|
no Peanut Ball
n=42 Participants
the peanut shaped birthing ball will not be utilized during labor
|
|---|---|---|
|
Participant Cesarean Delivery Incidence-Mode of Deliveries
|
15 number of cesarean deliveries
|
15 number of cesarean deliveries
|
SECONDARY outcome
Timeframe: up to 24 hoursNumber of participants that had post-delivery complications was reported
Outcome measures
| Measure |
Peanut Ball
n=39 Participants
the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized
|
no Peanut Ball
n=42 Participants
the peanut shaped birthing ball will not be utilized during labor
|
|---|---|---|
|
Number of Participants With Post-delivery Complications
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: length of labor, up to 24 hoursPopulation: rate of cervical dilation in centimeters per hour that subjects dilated in each group
rate in centimeters per hour of dilation
Outcome measures
| Measure |
Peanut Ball
n=39 Participants
the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized
|
no Peanut Ball
n=42 Participants
the peanut shaped birthing ball will not be utilized during labor
|
|---|---|---|
|
Cervical Dilation
|
1.49 centimeters per hour
Standard Deviation 0.95
|
1.74 centimeters per hour
Standard Deviation 2.37
|
Adverse Events
Peanut Ball
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
no Peanut 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