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

Primary Purpose

Labor Onset and Length Abnormalities, Prolonged Labor, Labor Long

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positioning with peanut ball
Traditional positioning
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Onset and Length Abnormalities focused on measuring peanut ball, labor, cesarean section

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Regional One Health Outpatient CenterRecruiting
  • Regional One HealthRecruiting
  • Regional One Health - Hollywood ClinicRecruiting
  • Regional One Health - Kirby Primary Care ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Traditional Positioning

Peanut Ball Positioning

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Rate of active stage of labor
Length of time from progression of 6cm cervical dilation to 10cm

Secondary Outcome Measures

Cesarean section rate
Proportion of patients who undergo delivery by cesarean section

Full Information

First Posted
August 3, 2022
Last Updated
September 5, 2022
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT05489315
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
May 19, 2023 (Anticipated)
Study Completion Date
May 19, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Onset and Length Abnormalities, Prolonged Labor, Labor Long, Labor; Poor
Keywords
peanut ball, labor, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Positioning
Arm Type
Other
Arm Description
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.
Arm Title
Peanut Ball Positioning
Arm Type
Experimental
Arm Description
Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.
Intervention Type
Device
Intervention Name(s)
Positioning with peanut ball
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional positioning
Intervention Description
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 Information:
Title
Rate of active stage of labor
Description
Length of time from progression of 6cm cervical dilation to 10cm
Time Frame
Expected <6 hours
Secondary Outcome Measure Information:
Title
Cesarean section rate
Description
Proportion of patients who undergo delivery by cesarean section
Time Frame
< 48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Nelson, MD, PhD
Phone
6155875832
Email
rnelso25@uthsc.edu
Facility Information:
Facility Name
Regional One Health Outpatient Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Butts, MD
Phone
901-515-3000
Facility Name
Regional One Health
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Butts, MD
Phone
901-275-3725
First Name & Middle Initial & Last Name & Degree
Ramona Phinehas
Phone
(901) 275-3725
Facility Name
Regional One Health - Hollywood Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Butts, MD
Phone
901-515-5500
Facility Name
Regional One Health - Kirby Primary Care Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Butts
Phone
901-515-5350

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26937158
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.
Results Reference
background
PubMed Identifier
26859467
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.
Results Reference
background
PubMed Identifier
29510425
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.
Results Reference
background
PubMed Identifier
31600716
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.
Results Reference
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Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor

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