Labor
Conditions
Keywords
labor duration
Brief summary
Labor patients who meet inclusion and exclusion criteria will be consented to be participate in this study to determine if the use of a peanut shaped birthing ball reduces the length of labor and reduces the incidence of cesarean section. Subjects will be randomized at the time of consent to either use the birthing ball or not use the birthing ball from the time of labor analgesia until complete cervical dilation.
Interventions
OTHERpeanut shaped birthing ball
peanut ball will be utilized
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* nulliparous * \>/= 18 years of age * not allergic to medications used for labor analgesia * no contraindications to labor analgesia * ASA I-II * EGA \>/= 37 weeks
Exclusion criteria
* under age 18 * Spanish speaking only * multiparous * EGA \<37 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Labor | up to 24 hours | time in minutes will be calculated from epidural catheter insertion until delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Satisfaction | length of labor, up to 24 hours | 11-point scale of 0=not satisfied up to 10=most satisfied of all |
| Participant Cesarean Delivery Incidence-Mode of Deliveries | up to 24 hours | the number of subjects who had to had a cesarean delivery |
| Number of Participants With Post-delivery Complications | up to 24 hours | Number of participants that had post-delivery complications was reported |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peanut Ball the peanut shaped birthing ball after labor analgesia will be utilized
peanut shaped birthing ball: peanut ball will be utilized | 39 |
| no Peanut Ball the peanut shaped birthing ball will not be utilized during labor | 42 |
| Total | 81 |
Baseline characteristics
| Characteristic | no Peanut Ball | Peanut Ball | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 39 Participants | 81 Participants |
| Gestational Age | 39.6 weeks STANDARD_DEVIATION 1.31 | 39.5 weeks STANDARD_DEVIATION 1.23 | 39.55 weeks STANDARD_DEVIATION 1.27 |
| Height | 161.3 centimeters STANDARD_DEVIATION 7.6 | 165.1 centimeters STANDARD_DEVIATION 5.1 | 163.2 centimeters STANDARD_DEVIATION 6.4 |
| Oxytocin Augmentation | 28 Participants | 24 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 32 Participants | 62 Participants |
| Region of Enrollment United States | 42 participants | 39 participants | 81 participants |
| Sex: Female, Male Female | 42 Participants | 39 Participants | 81 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 90.5 kilograms STANDARD_DEVIATION 22.7 | 91.4 kilograms STANDARD_DEVIATION 21.4 | 90.9 kilograms STANDARD_DEVIATION 21.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 42 |
| other Total, other adverse events | 0 / 39 | 0 / 42 |
| serious Total, serious adverse events | 0 / 39 | 0 / 42 |
Outcome results
Primary
Length of Labor
time in minutes will be calculated from epidural catheter insertion until delivery
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peanut Ball | Length of Labor | 387 minutes | Standard Deviation 256 |
| no Peanut Ball | Length of Labor | 441 minutes | Standard Deviation 269 |
Secondary
Maternal Satisfaction
11-point scale of 0=not satisfied up to 10=most satisfied of all
Time frame: length of labor, up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peanut Ball | Maternal Satisfaction | 8.86 units on a scale | Standard Deviation 2.01 |
| no Peanut Ball | Maternal Satisfaction | 7.88 units on a scale | Standard Deviation 2.68 |
Secondary
Number of Participants With Post-delivery Complications
Number of participants that had post-delivery complications was reported
Time frame: up to 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peanut Ball | Number of Participants With Post-delivery Complications | 0 Participants |
| no Peanut Ball | Number of Participants With Post-delivery Complications | 0 Participants |
Secondary
Participant Cesarean Delivery Incidence-Mode of Deliveries
the number of subjects who had to had a cesarean delivery
Time frame: up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peanut Ball | Participant Cesarean Delivery Incidence-Mode of Deliveries | 15 number of cesarean deliveries |
| no Peanut Ball | Participant Cesarean Delivery Incidence-Mode of Deliveries | 15 number of cesarean deliveries |
Post Hoc
Cervical Dilation
rate in centimeters per hour of dilation
Time frame: length of labor, up to 24 hours
Population: rate of cervical dilation in centimeters per hour that subjects dilated in each group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peanut Ball | Cervical Dilation | 1.49 centimeters per hour | Standard Deviation 0.95 |
| no Peanut Ball | Cervical Dilation | 1.74 centimeters per hour | Standard Deviation 2.37 |