NCT02539563

Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?

Terminated NA Results posted Last updated 18 March 2022

What this trial tests

NA trial testing peanut shaped birthing ball in Labor in 101 participants. Terminated before completion.

Timeline

4 June 2015

Primary endpoint
26 December 2017

26 December 2017

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	101
Start date	4 June 2015
Primary completion	26 December 2017
Estimated completion	26 December 2017
Sites	1 location across United States

Drugs / interventions tested

• peanut shaped birthing ball

Conditions studied

• Labor — all drugs for Labor →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 50, female only, with Labor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Length of Labor Primary · up to 24 hours

time in minutes will be calculated from epidural catheter insertion until delivery

Group	Value	95% CI
Peanut Ball	387	± 256
no Peanut Ball	441	± 269

Maternal Satisfaction Secondary · length of labor, up to 24 hours

11-point scale of 0=not satisfied up to 10=most satisfied of all

Group	Value	95% CI
Peanut Ball	8.86	± 2.01
no Peanut Ball	7.88	± 2.68

Participant Cesarean Delivery Incidence-Mode of Deliveries Secondary · up to 24 hours

the number of subjects who had to had a cesarean delivery

Group	Value	95% CI
Peanut Ball	15
no Peanut Ball	15

Number of Participants With Post-delivery Complications Secondary · up to 24 hours

Number of participants that had post-delivery complications was reported

Group	Value	95% CI
Peanut Ball	0
no Peanut Ball	0

Cervical Dilation Secondary · length of labor, up to 24 hours

rate in centimeters per hour of dilation

Group	Value	95% CI
Peanut Ball	1.49	± 0.95
no Peanut Ball	1.74	± 2.37

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.