LaborNCT02539563
Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
A study testing peanut shaped birthing ball in people with Labor, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor
- What is being tested?
- peanut shaped birthing ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2015to 26 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- nulliparous
- >/= 18 years of age
- not allergic to medications used for labor analgesia
- no contraindications to labor analgesia
- ASA I-II
- EGA >/= 37 weeks
Who cannot join
- under age 18
- Spanish speaking only
- multiparous
- EGA <37 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Novant Health-Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
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.
- Conditions
- Labor
- Being tested
- peanut shaped birthing ball
- Keywords
- labor duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peanut shaped birthing ballOther
peanut ball will be utilized
| Study group | Role | What they receive |
|---|---|---|
| peanut ball | Active comparator | the peanut shaped birthing ball after labor analgesia will be utilized Receives: Other: peanut shaped birthing ball |
| no peanut ball | No intervention | the peanut shaped birthing ball will not be utilized during labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Labor
time in minutes will be calculated from epidural catheter insertion until delivery
Measured: up to 24 hours
Secondary outcomes (3)
Maternal Satisfaction
11-point scale of 0=not satisfied up to 10=most satisfied of all
Measured: length of labor, up to 24 hours
Participant Cesarean Delivery Incidence-Mode of Deliveries
the number of subjects who had to had a cesarean delivery
Measured: up to 24 hours
Number of Participants With Post-delivery Complications
Number of participants that had post-delivery complications was reported
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start4 Jun 2015
- Primary completion26 Dec 2017
- Study completion26 Dec 2017
Why it stopped: During interim analysis, it appeared there were no difference in groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LaborStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert D'Angelo, MD, Principal investigator, WakeForest School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539563
- Sponsor's protocol ID
- IRB00033103
- Status last verified
- Jul 2018
- First submitted
- 25 Aug 2015
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16129992Halpern 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.
PubMed 9875879Martin 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.
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.
PubMed 24565430Tussey 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.
PubMed 26937158Tsen 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.
PubMed 10519493BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
PubMed 14199536
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
- ClinicalTrials.gov ID
- NCT02539563
- Acronym / sponsor ID
- IRB00033103
- Conditions
- Labor
- Keywords
- labor duration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: During interim analysis, it appeared there were no difference in groups
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 4 Jun 2015 (actual)
- Primary completion
- 26 Dec 2017 (actual)
- Study completion
- 26 Dec 2017 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Posted 29 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peanut ball | Active comparator | Other: peanut shaped birthing ballthe peanut shaped birthing ball after labor analgesia will be utilized |
| no peanut ball | No intervention | –the peanut shaped birthing ball will not be utilized during labor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- nulliparous
- >/= 18 years of age
- not allergic to medications used for labor analgesia
- no contraindications to labor analgesia
- ASA I-II
Key exclusion criteria (4 listed)
- under age 18
- Spanish speaking only
- multiparous
- EGA <37 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peanut shaped birthing ballpeanut ball will be utilized | Other | peanut ball |
Primary outcome
Length of Labor
Time frame: up to 24 hours
time in minutes will be calculated from epidural catheter insertion until delivery
3 secondary outcomes
Maternal Satisfaction
Time frame: length of labor, up to 24 hours
Participant Cesarean Delivery Incidence-Mode of Deliveries
Time frame: up to 24 hours
Number of Participants With Post-delivery Complications
Time frame: up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16129992Bucklin 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.
- Background: PubMed 9875879Halpern 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.
- BackgroundMartin 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.
- Background: PubMed 24565430American 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.
- Background: PubMed 26937158Tussey 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.
- Background: PubMed 10519493Tsen 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.
- Background: PubMed 14199536BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D'Angelo, MD principal investigator
WakeForest School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peanut shaped birthing ball in people with Labor, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Labor (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539563, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.