Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
1 other identifier
interventional
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2021
CompletedFirst Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2023
CompletedSeptember 7, 2022
September 1, 2022
1.8 years
August 3, 2022
September 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of active stage of labor
Length of time from progression of 6cm cervical dilation to 10cm
Expected <6 hours
Secondary Outcomes (1)
Cesarean section rate
< 48 hours
Study Arms (2)
Traditional Positioning
OTHERParticipants 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
EXPERIMENTALParticipants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Regional One Health Outpatient Center
Memphis, Tennessee, 38103, United States
Regional One Health
Memphis, Tennessee, 38103, United States
Regional One Health - Hollywood Clinic
Memphis, Tennessee, 38108, United States
Regional One Health - Kirby Primary Care Clinic
Memphis, Tennessee, 38119, United States
Related Publications (4)
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.
PMID: 26937158BACKGROUNDRoth 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.
PMID: 26859467BACKGROUNDMercier 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.
PMID: 29510425BACKGROUNDGrenvik 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.
PMID: 31600716BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Principal Investigator
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 5, 2022
Study Start
July 26, 2021
Primary Completion
May 19, 2023
Study Completion
May 19, 2023
Last Updated
September 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share