Labor Clinical Trial
Official title:
Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
Verified date | July 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Novant Health-Forsyth Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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
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 |
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