PregnancyNCT02190591
Use of Peanut Labor Ball Following Epidural Anesthesia
A study testing Peanut Labor Ball in people with Pregnancy, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after epidural anesthesia in patients who have never given birth. The study will measure the impact on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or forceps use), and third or fourth degree… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Peanut Labor Ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2015
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any nulliparous woman age ≥18 years presenting in labor (or for induction of labor) with:
- Gestation: 37 0/7weeks- 41 6/7weeks -early, full, and late term gestations (ACOG, 2013).
- Single gestation
- Vertex presentation
- Plans to deliver with epidural anesthesia
Who cannot join
- A complication of pregnancy at the time of admission (including known fetal anomalies or placental anomalies)
- Any muscular or skeletal limitations of the patient that does not allow for positioning with the peanut labor ball (PLB)
- An inability to speak or understand English language
- Preterm gestation: <36 6/7 weeks or Post-term >42 0/7weeks
- A multiple gestation
- Non-vertex presentation
Show all 10Show fewer
- Diabetes including Gestational Diabetes Mellitus (GDM)
- Order for magnesium sulfate infusion
- Plan for delivery without epidural
- Planned cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan TriHealth Hosptial
Cincinnati, Ohio, 45220
About this study
Official title: Use of Peanut Labor Ball for Pelvic Positioning for Nulliparous Patients Following Epidural
The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after epidural anesthesia in patients who have never given birth. The study will measure the impact on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or forceps use), and third or fourth degree laceration rates. This study will determine the impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and one with traditional wedge and pillow positioning. If benefits related to use of the PLB can be demonstrated, it is our intention that each labor room will be stocked with a PBL for use as standard of care.
This study will test the following hypotheses:
- The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal delivery rate in low risk nulliparous patients who receive epidural anesthesia compared to similar cohort using traditional wedge and pillow positioning.
- Using the PLB will impact the amount of time from epidural placement to complete dilation and the time of second stage of labor, when compared with the control cohort.
- Use of the PLB will impact the third and fourth degree laceration rates when compared with the control cohort.
Read the detailed description
See above
- Conditions
- Pregnancy
- Being tested
- Peanut Labor Ball
- Keywords
- epidural, pregnant, Cesarean Section, forceps, vaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Labor BallDevice
Peanut Labor Ball
| Study group | Role | What they receive |
|---|---|---|
| Pillow and Wedge | No intervention | Receiving standard care for positioning during labor using pillows and wedges |
| Peanut Labor Ball | Experimental | Use of the peanut labor ball within 30 minutes after epidural placement Receives: Device: Peanut Labor Ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery Rate
Rate of patients who deliver by cesarean section
Measured: .5-72 hours
Secondary outcomes (1)
Dilation to Second Stage Labor
Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation
Measured: thirty minutes after epidural given to birth of baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionAug 2015
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.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Baker, TriHealth Inc.
- Investigators
- Sarah Evans, RN, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190591
- Sponsor's protocol ID
- 14034-14-027
- Status last verified
- Mar 2017
- First submitted
- 16 May 2014
- Last updated
- 6 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Peanut Labor Ball for Pelvic Positioning for Nulliparous Patients Following Epidural
- ClinicalTrials.gov ID
- NCT02190591
- Acronym / sponsor ID
- 14034-14-027
- Conditions
- Pregnancy
- Keywords
- epidural, pregnant, Cesarean Section, forceps, vaginal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Posted 25 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after epidural anesthesia in patients who have never given birth. The study will measure the impact on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or forceps use), and third or fourth degree laceration rates. This study will determine the impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and one with traditional wedge and pillow positioning. If benefits related to use of the PLB can be demonstrated, it is our intention that each labor room will be stocked with a PBL for use as standard of care.
This study will test the following hypotheses:
- The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal delivery rate in low risk nulliparous patients who receive epidural anesthesia compared to similar cohort using traditional wedge and pillow positioning.
- Using the PLB will impact the amount of time from epidural placement to complete dilation and the time of second stage of labor, when compared with the control cohort.
- Use of the PLB will impact the third and fourth degree laceration rates when compared with the control cohort.
Detailed description
See above
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pillow and Wedge | No intervention | –Receiving standard care for positioning during labor using pillows and wedges |
| Peanut Labor Ball | Experimental | Device: Peanut Labor BallUse of the peanut labor ball within 30 minutes after epidural placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Any nulliparous woman age ≥18 years presenting in labor (or for induction of labor) with:
- Gestation: 37 0/7weeks- 41 6/7weeks -early, full, and late term gestations (ACOG, 2013).
- Single gestation
- Vertex presentation
- Plans to deliver with epidural anesthesia
Key exclusion criteria (10 listed)
- A complication of pregnancy at the time of admission (including known fetal anomalies or placental anomalies)
- Any muscular or skeletal limitations of the patient that does not allow for positioning with the peanut labor ball (PLB)
- An inability to speak or understand English language
- Preterm gestation: <36 6/7 weeks or Post-term >42 0/7weeks
- A multiple gestation
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 Labor BallPeanut Labor Ball | Device | Peanut Labor Ball |
Primary outcome
Delivery Rate
Time frame: .5-72 hours
Rate of patients who deliver by cesarean section
1 secondary outcome
Dilation to Second Stage Labor
Time frame: thirty minutes after epidural given to birth of baby
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Sarah Evans, RN principal investigator
TriHealth Inc.
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 Labor Ball in people with Pregnancy, run by TriHealth Inc. 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 6 Apr 2017. 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 25 Nov 2016). 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?
Delivery Rate (time frame: .5-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2017.