NCT05489315

Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of Tennessee · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Prolonged labor is associated with adverse maternal and fetal outcomes including infection, postpartum hemorrhage and increased NICU admission. One of the most common indications for cesarean section in the US is prolonged labor. Maternal positioning through labor facilitated by birthing balls is believed to help facilitate labor. Current data is inconclusive on whether or not the use of birthing balls is advantageous in a statistically significant manner. In this prospective randomized controlled trial, participants will be randomly selected to receive either the experimental intervention (repositioning peanut ball during labor) or the control intervention (the standard therapy of traditional repositioning during labor). Primary outcome: Time of active labor to delivery with and without use of the peanut ball. Secondary outcome: Cesarean section frequency.

Conditions

• Labor Onset and Length Abnormalities
• Prolonged Labor
• Labor Long
• Labor; Poor

Interventions

Type	Name	Description
DEVICE	Positioning with peanut ball	If participants are randomly selected to receive a peanut ball, the intent is for the patient to remain on the peanut ball during their labor progression.
OTHER	Traditional positioning	If participants are randomly selected to NOT receive a peanut ball, the intent is for the patient to undergo traditional positioning/use wedge pillows during their labor progression.

Timeline

• Start date: 2021-07-26
• Primary completion: 2023-05-19
• Completion: 2023-05-19
• First posted: 2022-08-05
• Last updated: 2022-09-07

Locations

4 sites across 1 country: United States