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

Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02539563
• Other study ID #: IRB00033103
• Status: Terminated
• Phase: N/A
• Start date: June 4, 2015
• Est. completion date: December 26, 2017

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: December 26, 2017
• Est. primary completion date: December 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor

Intervention

Other:
• peanut shaped birthing ball
peanut ball will be utilized

Locations

Country	Name	City	State
United States	Novant Health-Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (7)

American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine, Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026. — View Citation

BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. — View Citation

Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. — View Citation

Halpern SH, Leighton BL, Ohlsson A, Barrett JF, Rice A. Effect of epidural vs parenteral opioid analgesia on the progress of labor: a meta-analysis. JAMA. 1998 Dec 23-30;280(24):2105-10. — View Citation

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.

Tsen LC, Thue B, Datta S, Segal S. Is combined spinal-epidural analgesia associated with more rapid cervical dilation in nulliparous patients when compared with conventional epidural analgesia? Anesthesiology. 1999 Oct;91(4):920-5. — View Citation

Tussey CM, Botsios E, Gerkin RD, Kelly LA, Gamez J, Mensik J. Reducing Length of Labor and Cesarean Surgery Rate Using a Peanut Ball for Women Laboring With an Epidural. J Perinat Educ. 2015;24(1):16-24. doi: 10.1891/1058-1243.24.1.16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Labor	time in minutes will be calculated from epidural catheter insertion until delivery	up to 24 hours
Secondary	Maternal Satisfaction	11-point scale of 0=not satisfied up to 10=most satisfied of all	length of labor, up to 24 hours
Secondary	Participant Cesarean Delivery Incidence-Mode of Deliveries	the number of subjects who had to had a cesarean delivery	up to 24 hours
Secondary	Number of Participants With Post-delivery Complications	Number of participants that had post-delivery complications was reported	up to 24 hours