The Effect of the Use of Peanut Ball on Labor Time in Nulliparous Women

April 6, 2023 updated by: Ani Jacob, Northwell Health

The Effect of the Use of a Peanut Ball on Labor Time and "Pushing" After Epidural Anesthesia in Nulliparous Women.

Peanut ball use has become popular with midwives and nurses because it is an inexpensive, nonpharmacological intervention that can help with positioning the patient to decrease labor time. The peanut ball allows the patient to reposition her legs in a way that mimics squatting and changes the diameter of the pelvis. This can aid in cervical dilatation and the descent of the fetus. In turn, laboring down can decrease the time spent pushing and prevent maternal exhaustion.

This study aims to test the following hypotheses:

The use of the peanut ball compared to standard of care will:

  1. Reduce the time (in minutes) between administration of epidural and complete cervical dilation
  2. Reduce pushing time as measured by duration of time pushing to the delivery of the baby
  3. Decrease the rate of cesarean sections in nulliparous women

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized control study. Each patient who meets the inclusion criteria will be informed about the study within 12 hours of admission to the unit. When the participant is alert and prior to administration of medicinal pain relief measures, the patient will be asked to consent to be a participant. Basic admission demographic information will be collected from the electronic medical record (EMR) and will be used to identify potential subjects (inclusion/exclusion criteria). Recruitment will include a scripted informative conversation with the potential subject along with an informed consent to further determine eligibility and willingness to participate in the study.

The peanut ball size will be determined by the patient weight indicated on the peanut ball itself and compared with the patient's documented weight in the EMR. The ball will be inflated prior to use and a pictorial introduction of how to use the peanut ball will be shown to the study subject.

The peanut ball use will be discontinued immediately prior to the delivery of the baby. The study time will be documented and calculated for all subjects (treatment and control) from the time of introduction of epidural analgesia to the delivery of the baby.

The proposed Peanut Ball manufactured by Clinton industries at graylinemedical.com is made from durable, ribbed, heavy-walled, polyvinyl chloride (PVC) material, burst resistant, deflate slowly if punctured, and latex free with non-slip grip ridges. It is available in variable sizes ranging from 40 cm-70 cm in length. It is re-usable, after cleaning with hospital grade wipes. It is recommended that the peanut balls should be protected from sunlight and sharp objects.

Study Type

Interventional

Enrollment (Anticipated)

598

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 Contact Backup

Study Locations

  • United States
    • New York
      • Huntington, New York, United States, 11743
      • Manhasset, New York, United States, 11030
      • Mount Kisco, New York, United States, 10549
      • Riverhead, New York, United States, 11901

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women between 18 -50 years of age presenting in labor or for induction of labor

  • Nulliparous (first delivery)
  • 37 0/7- 41 6/7 weeks of gestation
  • Singleton, Vertex presentation
  • Plan to deliver with epidural anesthesia
  • Has had at least one vaginal exam to determine the cervical dilatation prior to the proposed intervention
  • Prescribed Oxytocin (Pitocin)

Exclusion Criteria:

  • Multi gravida women
  • Admitted in second stage of labor
  • Multiple gestations
  • Non-vertex presentations
  • Women receiving magnesium sulfate
  • Preterm or post term labor (<37 weeks or >42 weeks)
  • Women with hypertensive disorders of pregnancy
  • Diabetes including gestational diabetes
  • Muscular or skeletal limitations that does not allow for positioning
  • Un-medicated labors ( delivery without epidural, about 5-20% )
  • Category III fetal heart rate tracings
  • Suspected infections (e.g. STDs, viral/bacterial infections)
  • Planned cesarean delivery

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care
The control group subjects will receive standard of care during labor using pillows and wedges as positional devices.
Experimental: Peanut ball intervention
The experimental group will receive peanut ball as positioning device during labor
Device: Peanut Ball positioning device
Peanut Ball manufactured by Clinton industries at graylinemedical.com https://www.graylinemedical.com/products/clinton-industries-peanut-ball-peanut-ball-40-cm-yellow-8540?_pos=3&_sid=d6e52e63c&_ss=r

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease labor time
Time Frame: From epidural analgesia to delivery of the baby
The primary outcome goal is to decrease the length of first and second stage of labor in nulliparous women after receiving epidural analgesia, measured in minutes
From epidural analgesia to delivery of the baby

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease cesarean section deliveries
Time Frame: From epidural analgesia to delivery of the baby
to decrease the rate of cesarean births among nulliparous women and to decrease the rate of operative vaginal deliveries (forceps/vacuum) by 10%.
From epidural analgesia to delivery of the baby

Collaborators and Investigators

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

Sponsor

Northwell Health

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)

September 15, 2021

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 21-0330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregated study results/data will be shared with other researchers. Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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