Clinical trial NCT02539563: Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
Official title: Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor
Keywords: labor duration
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Length of Labor
timeFrame: up to 24 hours
Secondary outcomes:
measure: Maternal Satisfaction
timeFrame: length of labor, up to 24 hours
measure: Participant Cesarean Delivery Incidence-Mode of Deliveries
timeFrame: up to 24 hours
measure: Number of Participants With Post-delivery Complications
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novant Health-Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: WakeForest School of Medicine
name: Robert D'Angelo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bucklin BA, Hawkins JL, Anderson JR, Ullrich FA. Obstetric anesthesia workforce survey: twenty-year update. Anesthesiology. 2005 Sep;103(3):645-53. doi: 10.1097/00000542-200509000-00030. No abstract available.
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. doi: 10.1001/jama.280.24.2105.
citation: Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Matthews TJ. Births: final data for 2013. Natl Vital Stat Rep. 2015 Jan 15;64(1):1-65.
citation: 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.
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.
citation: 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. doi: 10.1097/00000542-199910000-00010.
citation: BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.