Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
NCT ID: NCT05489315
Last Updated: 2022-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
400 participants
INTERVENTIONAL
2021-07-26
2023-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of the Use of Peanut Ball on Labor Time in Nulliparous Women
NCT04998149
Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?
NCT02539563
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
NCT03772886
Effect of Peanut Balls Used of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
NCT06312449
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery
NCT05881629
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Traditional Positioning
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.
Traditional positioning
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.
Peanut Ball Positioning
Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.
Positioning with peanut ball
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Positioning with peanut ball
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 positioning
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
16 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Tennessee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rachel Nelson
Co-Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Regional One Health Outpatient Center
Memphis, Tennessee, United States
Regional One Health
Memphis, Tennessee, United States
Regional One Health - Hollywood Clinic
Memphis, Tennessee, United States
Regional One Health - Kirby Primary Care Clinic
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mary Butts, MD
Role: primary
Mary Butts, MD
Role: primary
Ramona Phinehas
Role: backup
Mary Butts, MD
Role: primary
Mary Butts
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Roth 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.
Mercier 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.
Grenvik 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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-08072-FB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.