Labor Onset and Length AbnormalitiesNCT05489315
Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
A study testing Positioning with peanut ball and Traditional positioning in people with Labor Onset and Length Abnormalities and Prolonged Labor, run by University of Tennessee at 4 sites in United States.
Trial summary
Prolonged labor is associated with adverse maternal and fetal outcomes including infection, postpartum hemorrhage and increased NICU admission. One of the most common indications for cesarean section in the US is prolonged labor. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Onset and Length Abnormalities, Prolonged Labor, Labor Long
- What is being tested?
- Positioning with peanut ball and Traditional positioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jul 2021to 19 May 2023
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Fetus must be vertex in position at the time of admission to L\&D
- Pregnant patients age 16 years old and above
- Singleton pregnancy (ie. one fetus)
- Patients who receive induction and augmentation of labor may be included
- Include both nulliparous and multiparous women
- Patients with HTN, diabetes, and obesity at any point in their pregnancy may be included
Show all 9Show fewer
- Patients may be included in the study regardless of whether or not they received an epidural
- Patients who have been randomly assigned to receive a peanut ball must be placed on the peanut ball at 6cm dilation, not earlier.
- Patients who present to L\&D dilated to 4cm may be included
Who cannot join
- TOLACs and VBACs will be excluded
- Multiple gestation will be excluded
- Category 3 fetal tracing will be excluded
- Chorioamnionitis will be excluded
- Patients who present to L\&D at 6cm cervical dilation will be excluded
- Patients placed on the peanut ball before 6cm cervical dilation will be excluded
- Patients with fetal malpresentation will be excluded
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Regional One Health Outpatient Center
Memphis, Tennessee, 38103
Mary Butts, MD, 901-515-3000
- Recruiting
Regional One Health
Memphis, Tennessee, 38103
Mary Butts, MD, 901-275-3725
Ramona Phinehas, (901) 275-3725
- Recruiting
Regional One Health - Hollywood Clinic
Memphis, Tennessee, 38108
Mary Butts, MD, 901-515-5500
- Recruiting
Regional One Health - Kirby Primary Care Clinic
Memphis, Tennessee, 38119
Mary Butts, 901-515-5350
About this study
Prolonged labor is associated with adverse maternal and fetal outcomes including infection, postpartum hemorrhage and increased NICU admission. One of the most common indications for cesarean section in the US is prolonged labor. Maternal positioning through labor facilitated by birthing balls is believed to help facilitate labor. Current data is inconclusive on whether or not the use of birthing balls is advantageous in a statistically significant manner.
In this prospective randomized controlled trial, participants will be randomly selected to receive either the experimental intervention (repositioning peanut ball during labor) or the control intervention (the standard therapy of traditional repositioning during labor).
Read more
Primary outcome: Time of active labor to delivery with and without use of the peanut ball.
Secondary outcome: Cesarean section frequency.
- Being tested
- Positioning with peanut ball, Traditional positioning
- Keywords
- peanut ball, labor, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning with peanut ballDevice
If participants are randomly selected to receive a peanut ball, the intent is for the patient to remain on the peanut ball during their labor progression.
Traditional positioningOther
If participants are randomly selected to NOT receive a peanut ball, the intent is for the patient to undergo traditional positioning/use wedge pillows during their labor progression.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Positioning | Other | Participants who are randomly assigned to NOT receive a peanut ball will undergo placement on a wedge pillow and/or traditional positioning during their labor progression at 6cm cervical dilation. Receives: Other: Traditional positioning |
| Peanut Ball Positioning | Experimental | Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation. Receives: Device: Positioning with peanut ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of active stage of labor
Length of time from progression of 6cm cervical dilation to 10cm
Measured: Expected <6 hours
Secondary outcomes (1)
Cesarean section rate
Proportion of patients who undergo delivery by cesarean section
Measured: < 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start26 Jul 2021
- Primary completion19 May 2023 (estimated)
- Study completion19 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor Onset and Length AbnormalitiesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Nelson, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489315
- Sponsor's protocol ID
- 21-08072-FB
- Status last verified
- Sep 2022
- First submitted
- 3 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26937158Roth C, Dent SA, Parfitt SE, Hering SL, Bay RC. Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):140-6. doi: 10.1097/NMC.0000000000000232.
PubMed 26859467Mercier RJ, Kwan M. Impact of Peanut Ball Device on the Duration of Active Labor: A Randomized Control Trial. Am J Perinatol. 2018 Aug;35(10):1006-1011. doi: 10.1055/s-0038-1636531. Epub 2018 Mar 6.
PubMed 29510425Grenvik JM, Rosenthal E, Saccone G, Della Corte L, Quist-Nelson J, Gerkin RD, Gimovsky AC, Kwan M, Mercier R, Berghella V. Peanut ball for decreasing length of labor: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:159-165. doi: 10.1016/j.ejogrb.2019.09.018. Epub 2019 Sep 20.
PubMed 31600716
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
- ClinicalTrials.gov ID
- NCT05489315
- Acronym / sponsor ID
- 21-08072-FB
- Keywords
- peanut ball, labor, cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 19 May 2023 (estimated)
- Study completion
- 19 May 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
Prolonged labor is associated with adverse maternal and fetal outcomes including infection, postpartum hemorrhage and increased NICU admission. One of the most common indications for cesarean section in the US is prolonged labor. Maternal positioning through labor facilitated by birthing balls is believed to help facilitate labor. Current data is inconclusive on whether or not the use of birthing balls is advantageous in a statistically significant manner.
In this prospective randomized controlled trial, participants will be randomly selected to receive either the experimental intervention (repositioning peanut ball during labor) or the control intervention (the standard therapy of traditional repositioning during labor).
Primary outcome: Time of active labor to delivery with and without use of the peanut ball.
Secondary outcome: Cesarean section frequency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Positioning | Other | Other: Traditional positioningParticipants who are randomly assigned to NOT receive a peanut ball will undergo placement on a wedge pillow and/or traditional positioning during their labor progression at 6cm cervical dilation. |
| Peanut Ball Positioning | Experimental | Device: Positioning with peanut ballParticipants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Fetus must be vertex in position at the time of admission to L\&D
- Pregnant patients age 16 years old and above
- Singleton pregnancy (ie. one fetus)
- Patients who receive induction and augmentation of labor may be included
- Include both nulliparous and multiparous women
Key exclusion criteria (7 listed)
- TOLACs and VBACs will be excluded
- Multiple gestation will be excluded
- Category 3 fetal tracing will be excluded
- Chorioamnionitis will be excluded
- Patients who present to L\&D at 6cm cervical dilation will be excluded
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 |
|---|---|---|
| Positioning with peanut ballIf participants are randomly selected to receive a peanut ball, the intent is for the patient to remain on the peanut ball during their labor progression. | Device | Peanut Ball Positioning |
| Traditional positioningIf participants are randomly selected to NOT receive a peanut ball, the intent is for the patient to undergo traditional positioning/use wedge pillows during their labor progression. | Other | Traditional Positioning |
Primary outcome
Rate of active stage of labor
Time frame: Expected <6 hours
Length of time from progression of 6cm cervical dilation to 10cm
1 secondary outcome
Cesarean section rate
Time frame: < 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- 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 26859467Roth C, Dent SA, Parfitt SE, Hering SL, Bay RC. Randomized Controlled Trial of Use of the Peanut Ball During Labor. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):140-6. doi: 10.1097/NMC.0000000000000232.
- Background: PubMed 29510425Mercier RJ, Kwan M. Impact of Peanut Ball Device on the Duration of Active Labor: A Randomized Control Trial. Am J Perinatol. 2018 Aug;35(10):1006-1011. doi: 10.1055/s-0038-1636531. Epub 2018 Mar 6.
- Background: PubMed 31600716Grenvik JM, Rosenthal E, Saccone G, Della Corte L, Quist-Nelson J, Gerkin RD, Gimovsky AC, Kwan M, Mercier R, Berghella V. Peanut ball for decreasing length of labor: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:159-165. doi: 10.1016/j.ejogrb.2019.09.018. Epub 2019 Sep 20.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning with peanut ball and Traditional positioning in people with Labor Onset and Length Abnormalities and Prolonged Labor, run by University of Tennessee 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Nelson, MD, PhD (6155875832, rnelso25@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of active stage of labor (time frame: Expected <6 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 NCT05489315, which also lists 4 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 7 Sep 2022.