Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?

March 9, 2022 updated by: Wake Forest University Health Sciences
Labor patients who meet inclusion and exclusion criteria will be consented to be participate in this study to determine if the use of a peanut shaped birthing ball reduces the length of labor and reduces the incidence of cesarean section. Subjects will be randomized at the time of consent to either use the birthing ball or not use the birthing ball from the time of labor analgesia until complete cervical dilation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

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 Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health-Forsyth Medical Center

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • nulliparous
  • >/= 18 years of age
  • not allergic to medications used for labor analgesia
  • no contraindications to labor analgesia
  • ASA I-II
  • EGA >/= 37 weeks

Exclusion Criteria:

  • under age 18
  • Spanish speaking only
  • multiparous
  • EGA <37 weeks

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: peanut ball
the peanut shaped birthing ball after labor analgesia will be utilized
Other: peanut shaped birthing ball
peanut ball will be utilized
No Intervention: no peanut ball
the peanut shaped birthing ball will not be utilized during labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Labor
Time Frame: up to 24 hours
time in minutes will be calculated from epidural catheter insertion until delivery
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Satisfaction
Time Frame: length of labor, up to 24 hours
11-point scale of 0=not satisfied up to 10=most satisfied of all
length of labor, up to 24 hours
Participant Cesarean Delivery Incidence-Mode of Deliveries
Time Frame: up to 24 hours
the number of subjects who had to had a cesarean delivery
up to 24 hours
Number of Participants With Post-delivery Complications
Time Frame: up to 24 hours
Number of participants that had post-delivery complications was reported
up to 24 hours

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Robert D'Angelo, MD, WakeForest School of Medicine

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)

June 4, 2015

Primary Completion (Actual)

December 26, 2017

Study Completion (Actual)

December 26, 2017

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00033103

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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