Recruiting

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

Sponsor:

University of Tennessee

Code:

NCT05489315

Conditions

Labor Onset and Length Abnormalities

Prolonged Labor

Labor Long

Labor; Poor

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Accepted

Interventions

Positioning with peanut ball

Traditional positioning

Study Details

Brief 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

Study ID

NCT05489315

Start date

Jul 26, 2021

Status verified date

Sep, 2022

Completion date

May 19, 2023

Anticipated

Primary completion date

May 19, 2023

Anticipated

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Traditional Positioning

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.

experimental: Peanut Ball Positioning

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

Interventions

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.

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.

Primary outcome measure

Rate of active stage of labor [ Time Frame: Expected <6 hours ]

Central Contacts and Locations

Central contacts

Rachel Nelson, MD, PhD

6155875832 rnelso25@uthsc.edu

Locations

Regional One Health Outpatient Center

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Mary Butts, MD

901-515-3000

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Mary Butts, MD

901-275-3725

Ramona Phinehas

(901) 275-3725

Regional One Health - Hollywood Clinic

Recruiting

Memphis, Tennessee, United States, 38108

Contacts

Mary Butts, MD

901-515-5500

Regional One Health - Kirby Primary Care Clinic

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Mary Butts

901-515-5350

More Information

Sponsor

University of Tennessee

Last update posted

Sep 7, 2022

Last verified

Sep, 2022

Keywords

peanut ball
labor
cesarean section

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2022-09-07.