NCT02539563

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 29, 2019

Completed
Last Updated

March 18, 2022

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

August 25, 2015

Results QC Date

August 22, 2018

Last Update Submit

March 9, 2022

Conditions

Labor

Keywords

labor duration

Outcome Measures

Primary Outcomes (1)

  • Length of Labor

    time in minutes will be calculated from epidural catheter insertion until delivery

    up to 24 hours

Secondary Outcomes (3)

  • Maternal Satisfaction

    length of labor, up to 24 hours

  • Participant Cesarean Delivery Incidence-Mode of Deliveries

    up to 24 hours

  • Number of Participants With Post-delivery Complications

    up to 24 hours

Study Arms (2)

peanut ball

ACTIVE COMPARATOR

the peanut shaped birthing ball after labor analgesia will be utilized

Other: peanut shaped birthing ball

no peanut ball

NO INTERVENTION

the peanut shaped birthing ball will not be utilized during labor

Interventions

peanut shaped birthing ballOTHER

peanut ball will be utilized

peanut ball

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • nulliparous
  • \>/= 18 years of age
  • not allergic to medications used for labor analgesia
  • no contraindications to labor analgesia
  • ASA I-II
  • EGA \>/= 37 weeks

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novant Health-Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (7)

  • 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.

    PMID: 16129992BACKGROUND

  • 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.

    PMID: 9875879BACKGROUND

  • 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.

    PMID: 25603115BACKGROUND

  • 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.

    PMID: 24565430BACKGROUND

  • 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.

    PMID: 26937158BACKGROUND

  • 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.

    PMID: 10519493BACKGROUND

  • BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.

    PMID: 14199536BACKGROUND

Results Point of Contact

Title
Lynnette Harris, BSN
Organization
Wake Forest School of Medicine
lcharris@wakehealth.edu
336-716-6049

Study Officials

  • Robert D'Angelo, MD

    WakeForest School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 3, 2015

Study Start

June 4, 2015

Primary Completion

December 26, 2017

Study Completion

December 26, 2017

Last Updated

March 18, 2022

Results First Posted

April 29, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)