Laboring WomenNCT04998149
The Effect of the Use of Peanut Ball on Labor Time in Nulliparous Women
A study testing Peanut Ball positioning device in people with Laboring Women, run by Northwell Health at 4 sites in United States.
Trial summary
Peanut ball use has become popular with midwives and nurses because it is an inexpensive, nonpharmacological intervention that can help with positioning the patient to decrease labor time. The peanut ball allows the patient to reposition her legs in a way that mimics squatting and changes the diameter of the pelvis. 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
- Laboring Women
- What is being tested?
- Peanut Ball positioning device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Sep 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women between 18 -50 years of age presenting in labor or for induction of labor
- Nulliparous (first delivery)
- 37 0/7- 41 6/7 weeks of gestation
- Singleton, Vertex presentation
- Plan to deliver with epidural anesthesia
- Has had at least one vaginal exam to determine the cervical dilatation prior to the proposed intervention
- Prescribed Oxytocin (Pitocin)
Who cannot join
- Multi gravida women
- Admitted in second stage of labor
- Multiple gestations
- Non-vertex presentations
- Women receiving magnesium sulfate
- Preterm or post term labor (<37 weeks or >42 weeks)
Show all 13Show fewer
- Women with hypertensive disorders of pregnancy
- Diabetes including gestational diabetes
- Muscular or skeletal limitations that does not allow for positioning
- Un-medicated labors ( delivery without epidural, about 5-20% )
- Category III fetal heart rate tracings
- Suspected infections (e.g. STDs, viral/bacterial infections)
- Planned cesarean delivery
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Huntington Hospital
Huntington, New York, 11743
North Shore University Hospital
Manhasset, New York, 11030
Northwell health, Northern Westchester Hospital
Mount Kisco, New York, 10549
Northwell Health, Peconic Bay Medical Center
Riverhead, New York, 11901
About this study
Official title: The Effect of the Use of a Peanut Ball on Labor Time and "Pushing" After Epidural Anesthesia in Nulliparous Women.
Peanut ball use has become popular with midwives and nurses because it is an inexpensive, nonpharmacological intervention that can help with positioning the patient to decrease labor time. The peanut ball allows the patient to reposition her legs in a way that mimics squatting and changes the diameter of the pelvis. This can aid in cervical dilatation and the descent of the fetus. In turn, laboring down can decrease the time spent pushing and prevent maternal exhaustion.
This study aims to test the following hypotheses:
Read more
The use of the peanut ball compared to standard of care will:
- Reduce the time (in minutes) between administration of epidural and complete cervical dilation
- Reduce pushing time as measured by duration of time pushing to the delivery of the baby
- Decrease the rate of cesarean sections in nulliparous women
Read the detailed description
This is a randomized control study. Each patient who meets the inclusion criteria will be informed about the study within 12 hours of admission to the unit. When the participant is alert and prior to administration of medicinal pain relief measures, the patient will be asked to consent to be a participant. Basic admission demographic information will be collected from the electronic medical record (EMR) and will be used to identify potential subjects (inclusion/exclusion criteria). Recruitment will include a scripted informative conversation with the potential subject along with an informed consent to further determine eligibility and willingness to participate in the study.
The peanut ball size will be determined by the patient weight indicated on the peanut ball itself and compared with the patient's documented weight in the EMR. The ball will be inflated prior to use and a pictorial introduction of how to use the peanut ball will be shown to the study subject.
The peanut ball use will be discontinued immediately prior to the delivery of the baby. The study time will be documented and calculated for all subjects (treatment and control) from the time of introduction of epidural analgesia to the delivery of the baby.
The proposed Peanut Ball manufactured by Clinton industries at graylinemedical.com is made from durable, ribbed, heavy-walled, polyvinyl chloride (PVC) material, burst resistant, deflate slowly if punctured, and latex free with non-slip grip ridges. It is available in variable sizes ranging from 40 cm-70 cm in length. It is re-usable, after cleaning with hospital grade wipes. It is recommended that the peanut balls should be protected from sunlight and sharp objects.
- Conditions
- Laboring Women
- Being tested
- Peanut Ball positioning device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Ball positioning deviceDevice
Peanut Ball manufactured by Clinton industries at graylinemedical.com https://www.graylinemedical.com/products/clinton-industries-peanut-ball-peanut-ball-40-cm-yellow-8540?_pos=3\&_sid=d6e52e63c\&_ss=r
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | The control group subjects will receive standard of care during labor using pillows and wedges as positional devices. |
| Peanut ball intervention | Experimental | The experimental group will receive peanut ball as positioning device during labor Receives: Device: Peanut Ball positioning device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease labor time
The primary outcome goal is to decrease the length of first and second stage of labor in nulliparous women after receiving epidural analgesia, measured in minutes
Measured: From epidural analgesia to delivery of the baby
Secondary outcomes (1)
Decrease cesarean section deliveries
to decrease the rate of cesarean births among nulliparous women and to decrease the rate of operative vaginal deliveries (forceps/vacuum) by 10%.
Measured: From epidural analgesia to delivery of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start15 Sep 2021
- Primary completion30 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laboring WomenStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be a standard group and an intervention group selected by BRMS.
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ani Jacob, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998149
- Sponsor's protocol ID
- 21-0330
- Status last verified
- Nov 2024
- First submitted
- 4 Aug 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only aggregated study results/data will be shared with other researchers. Individual participant data will not be shared.
Publications
Delgado A, Maia T, Melo RS, Lemos A. Birth ball use for women in labor: A systematic review and meta-analysis. Complement Ther Clin Pract. 2019 May;35:92-101. doi: 10.1016/j.ctcp.2019.01.015. Epub 2019 Feb 2.
PubMed 31003693Tussey 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 26937158Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):E9-E10. doi: 10.1097/NMC.0000000000000240. No abstract available.
PubMed 27128653
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of a Peanut Ball on Labor Time and "Pushing" After Epidural Anesthesia in Nulliparous Women.
- ClinicalTrials.gov ID
- NCT04998149
- Acronym / sponsor ID
- 21-0330
- Conditions
- Laboring Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peanut ball use has become popular with midwives and nurses because it is an inexpensive, nonpharmacological intervention that can help with positioning the patient to decrease labor time. The peanut ball allows the patient to reposition her legs in a way that mimics squatting and changes the diameter of the pelvis. This can aid in cervical dilatation and the descent of the fetus. In turn, laboring down can decrease the time spent pushing and prevent maternal exhaustion.
This study aims to test the following hypotheses:
The use of the peanut ball compared to standard of care will:
- Reduce the time (in minutes) between administration of epidural and complete cervical dilation
- Reduce pushing time as measured by duration of time pushing to the delivery of the baby
- Decrease the rate of cesarean sections in nulliparous women
Detailed description
This is a randomized control study. Each patient who meets the inclusion criteria will be informed about the study within 12 hours of admission to the unit. When the participant is alert and prior to administration of medicinal pain relief measures, the patient will be asked to consent to be a participant. Basic admission demographic information will be collected from the electronic medical record (EMR) and will be used to identify potential subjects (inclusion/exclusion criteria). Recruitment will include a scripted informative conversation with the potential subject along with an informed consent to further determine eligibility and willingness to participate in the study.
The peanut ball size will be determined by the patient weight indicated on the peanut ball itself and compared with the patient's documented weight in the EMR. The ball will be inflated prior to use and a pictorial introduction of how to use the peanut ball will be shown to the study subject.
The peanut ball use will be discontinued immediately prior to the delivery of the baby. The study time will be documented and calculated for all subjects (treatment and control) from the time of introduction of epidural analgesia to the delivery of the baby.
The proposed Peanut Ball manufactured by Clinton industries at graylinemedical.com is made from durable, ribbed, heavy-walled, polyvinyl chloride (PVC) material, burst resistant, deflate slowly if punctured, and latex free with non-slip grip ridges. It is available in variable sizes ranging from 40 cm-70 cm in length. It is re-usable, after cleaning with hospital grade wipes. It is recommended that the peanut balls should be protected from sunlight and sharp objects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be a standard group and an intervention group selected by BRMS.
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –The control group subjects will receive standard of care during labor using pillows and wedges as positional devices. |
| Peanut ball intervention | Experimental | Device: Peanut Ball positioning deviceThe experimental group will receive peanut ball as positioning device during labor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women between 18 -50 years of age presenting in labor or for induction of labor
- Nulliparous (first delivery)
- 37 0/7- 41 6/7 weeks of gestation
- Singleton, Vertex presentation
- Plan to deliver with epidural anesthesia
Key exclusion criteria (13 listed)
- Multi gravida women
- Admitted in second stage of labor
- Multiple gestations
- Non-vertex presentations
- Women receiving magnesium sulfate
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 Ball positioning devicePeanut Ball manufactured by Clinton industries at graylinemedical.com https://www.graylinemedical.com/products/clinton-industries-peanut-ball-peanut-ball-40-cm-yellow-8540?_pos=3\&_sid=d6e52e63c\&_ss=r | Device | Peanut ball intervention |
Primary outcome
Decrease labor time
Time frame: From epidural analgesia to delivery of the baby
The primary outcome goal is to decrease the length of first and second stage of labor in nulliparous women after receiving epidural analgesia, measured in minutes
1 secondary outcome
Decrease cesarean section deliveries
Time frame: From epidural analgesia to delivery of the baby
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 31003693Delgado A, Maia T, Melo RS, Lemos A. Birth ball use for women in labor: A systematic review and meta-analysis. Complement Ther Clin Pract. 2019 May;35:92-101. doi: 10.1016/j.ctcp.2019.01.015. Epub 2019 Feb 2.
- 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 27128653Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):E9-E10. doi: 10.1097/NMC.0000000000000240. No abstract available.
- Individual participant dataSharing planned: No. Only aggregated study results/data will be shared with other researchers. Individual participant data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut Ball positioning device in people with Laboring Women, run by Northwell Health at 4 sites 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 7 inclusion and 13 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease labor time (time frame: From epidural analgesia to delivery of the baby). 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 NCT04998149, which also lists 3 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 14 Nov 2024.