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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02539563
Other study ID # IRB00033103
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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