Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut Ball positioning device | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From epidural analgesia to delivery of the baby |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | From epidural analgesia to delivery of the baby |
Not provided
Inclusion Criteria:
Women between 18 -50 years of age presenting in labor or for induction of labor
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Hospital | Huntington | New York | 11743 | United States | ||
| North Shore University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31003693 | Background | 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. | |
| 26937158 | Background | 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. |
Not provided
Not provided
Only aggregated study results/data will be shared with other researchers. Individual participant data will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
There will be a standard group and an intervention group selected by BRMS.
Not provided
Not provided
Not provided
Not provided
| Manhasset |
| New York |
| 11030 |
| United States |
| Northwell health, Northern Westchester Hospital | Mount Kisco | New York | 10549 | United States |
| Northwell Health, Peconic Bay Medical Center | Riverhead | New York | 11901 | United States |
| 27128653 | Background | Randomized 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. |