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

September 5, 2022 updated by: Rachel Nelson, University of Tennessee

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Regional One Health
        • Contact:
          • Mary Butts, MD
          • Phone Number: 901-275-3725
        • Contact:
          • Ramona Phinehas
          • Phone Number: (901) 275-3725
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Regional One Health Outpatient Center
        • Contact:
          • Mary Butts, MD
          • Phone Number: 901-515-3000
      • Memphis, Tennessee, United States, 38108
        • Recruiting
        • Regional One Health - Hollywood Clinic
        • Contact:
          • Mary Butts, MD
          • Phone Number: 901-515-5500
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Regional One Health - Kirby Primary Care Clinic
        • Contact:
          • Mary Butts
          • Phone Number: 901-515-5350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
Experimental: Peanut Ball Positioning
Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of active stage of labor
Time Frame: Expected <6 hours
Length of time from progression of 6cm cervical dilation to 10cm
Expected <6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean section rate
Time Frame: < 48 hours
Proportion of patients who undergo delivery by cesarean section
< 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2021

Primary Completion (Anticipated)

May 19, 2023

Study Completion (Anticipated)

May 19, 2023

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-08072-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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