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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02539563
Recruitment Status : Terminated (During interim analysis, it appeared there were no difference in groups)
First Posted : September 3, 2015
Results First Posted : April 29, 2019
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Labor Other: peanut shaped birthing ball Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
Actual Study Start Date : June 4, 2015
Actual Primary Completion Date : December 26, 2017
Actual Study Completion Date : December 26, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Length of Labor [ Time Frame: up to 24 hours ]
    time in minutes will be calculated from epidural catheter insertion until delivery


Secondary Outcome Measures :
  1. 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

  2. Participant Cesarean Delivery Incidence-Mode of Deliveries [ Time Frame: up to 24 hours ]
    the number of subjects who had to had a cesarean delivery

  3. Number of Participants With Post-delivery Complications [ Time Frame: up to 24 hours ]
    Number of participants that had post-delivery complications was reported


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539563


Locations
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United States, North Carolina
Novant Health-Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Robert D'Angelo, MD WakeForest School of Medicine
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Study Protocol and Statistical Analysis Plan  [PDF] June 1, 2015

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Martin JA, et al. Births: Final Report 2013. National Vital Statistics Report, 2015; Vol 64: Number 1. Also accessed at: http://www.cdc.gov/nchs/fastats/delivery.htm.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02539563    
Other Study ID Numbers: IRB00033103
First Posted: September 3, 2015    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: March 18, 2022
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
labor duration