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

Not Applicable

Recruiting

• Conditions: Prolonged Labor; Labor; Poor; Labor Onset and Length Abnormalities; Labor Long
• Interventions: Other: Traditional positioning; Device: Positioning with peanut ball

• Registration Number: NCT05489315
• Lead Sponsor: University of Tennessee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-26
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07
• Primary Completion: 2023-05-19
• Study Completion: 2023-05-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Positioning	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.
Peanut Ball Positioning	Positioning with peanut ball	Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.

Primary Outcome Measures

Name	Time	Method
Rate of active stage of labor	Expected <6 hours	Length of time from progression of 6cm cervical dilation to 10cm

Secondary Outcome Measures

Name	Time	Method
Cesarean section rate	< 48 hours	Proportion of patients who undergo delivery by cesarean section

Trial Locations

Locations (4)

Regional One Health; 🇺🇸 Memphis, Tennessee, United States

Regional One Health Outpatient Center; 🇺🇸 Memphis, Tennessee, United States

Regional One Health - Hollywood Clinic; 🇺🇸 Memphis, Tennessee, United States

Regional One Health - Kirby Primary Care Clinic; 🇺🇸 Memphis, Tennessee, United States