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

Not Applicable

Terminated

• Conditions: Labor
• Interventions: Other: peanut shaped birthing ball

• Registration Number: NCT02539563
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06-04
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2017-12-26
• Study Completion: 2017-12-26
• Status Verified: 2018-07
• Results First Submitted: 2018-08-22
• Results First Submitted QC: 2019-01-25
• Results First Posted: 2019-04-29
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 101

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
peanut ball	peanut shaped birthing ball	the peanut shaped birthing ball after labor analgesia will be utilized

Primary Outcome Measures

Name	Time	Method
Length of Labor	up to 24 hours	time in minutes will be calculated from epidural catheter insertion until delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novant Health-Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States