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

Labor Long Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489315
• Other study ID #: 21-08072-FB
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: May 19, 2023

Study information

• Verified date: September 2022
• Source: University of Tennessee Health Science Center
• Contact: Rachel Nelson, MD, PhD
• Phone: 6155875832
• Email: rnelso25[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Regional One Health	Memphis	Tennessee
United States	Regional One Health - Hollywood Clinic	Memphis	Tennessee
United States	Regional One Health - Kirby Primary Care Clinic	Memphis	Tennessee
United States	Regional One Health Outpatient Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Grenvik JM, Rosenthal E, Saccone G, Della Corte L, Quist-Nelson J, Gerkin RD, Gimovsky AC, Kwan M, Mercier R, Berghella V. Peanut ball for decreasing length of labor: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:159-165. doi: 10.1016/j.ejogrb.2019.09.018. Epub 2019 Sep 20. — View Citation

Mercier RJ, Kwan M. Impact of Peanut Ball Device on the Duration of Active Labor: A Randomized Control Trial. Am J Perinatol. 2018 Aug;35(10):1006-1011. doi: 10.1055/s-0038-1636531. Epub 2018 Mar 6. — View Citation

Roth C, Dent SA, Parfitt SE, Hering SL, Bay RC. Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):140-6. doi: 10.1097/NMC.0000000000000232. — View Citation

Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing Length of Labor and Cesarean Surgery Rate Using a Peanut Ball for Women Laboring With an Epidural. J Perinat Educ. 2015;24(1):16-24. doi: 10.1891/1058-1243.24.1.16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of active stage of labor	Length of time from progression of 6cm cervical dilation to 10cm	Expected <6 hours
Secondary	Cesarean section rate	Proportion of patients who undergo delivery by cesarean section	< 48 hours