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

University of Tennessee

Status: Enrolling

Conditions: Labor; Poor; Prolonged Labor; Labor Onset and Length Abnormalities; Labor Long

Treatments: Device: Positioning with peanut ball; Other: Traditional positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05489315

21-08072-FB

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fetus must be vertex in position at the time of admission to L&D
• Pregnant patients age 16 years old and above
• Singleton pregnancy (ie. one fetus)
• Patients who receive induction and augmentation of labor may be included
• Include both nulliparous and multiparous women
• Patients with HTN, diabetes, and obesity at any point in their pregnancy may be included
• Patients may be included in the study regardless of whether or not they received an epidural
• Patients who have been randomly assigned to receive a peanut ball must be placed on the peanut ball at 6cm dilation, not earlier.
• Patients who present to L&D dilated to 4cm may be included

Exclusion criteria

• TOLACs and VBACs will be excluded
• Multiple gestation will be excluded
• Category 3 fetal tracing will be excluded
• Chorioamnionitis will be excluded
• Patients who present to L&D at 6cm cervical dilation will be excluded
• Patients placed on the peanut ball before 6cm cervical dilation will be excluded
• Patients with fetal malpresentation will be excluded

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Traditional Positioning

Other group

Description:

Participants who are randomly assigned to NOT receive a peanut ball will undergo placement on a wedge pillow and/or traditional positioning during their labor progression at 6cm cervical dilation.

Treatment:

Other: Traditional positioning

Peanut Ball Positioning

Experimental group

Description:

Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.

Treatment:

Device: Positioning with peanut ball