UnknownNot Applicable

Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor

United States400 participantsStarted 2021-07-26

Plain-language 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. 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.

Who can participate

Age range

16 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of active stage of labor

Timeframe: Expected <6 hours

Trial details

NCT IDNCT05489315

SponsorUniversity of Tennessee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-19

Contact for this trial

Rachel Nelson, MD, PhD

6155875832 rnelso25@uthsc.edu

View on ClinicalTrials.gov More Labor Onset and Length Abnormalities trials