Clinical trial NCT05489315: Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
Official title: Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Onset and Length Abnormalities
Prolonged Labor
Labor Long
Labor; Poor
Keywords: peanut ball
labor
cesarean section
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of active stage of labor
timeFrame: Expected <6 hours
Secondary outcomes:
measure: Cesarean section rate
timeFrame: < 48 hours
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Regional One Health Outpatient Center
state: Tennessee
city: Memphis
country: United States
facility: Regional One Health
state: Tennessee
city: Memphis
country: United States
facility: Regional One Health - Hollywood Clinic
state: Tennessee
city: Memphis
country: United States
facility: Regional One Health - Kirby Primary Care Clinic
state: Tennessee
Study officials:
References:
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.
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.
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.
citation: 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.