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
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positioning with peanut ball | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of active stage of labor | Length of time from progression of 6cm cervical dilation to 10cm | Expected <6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean section rate | Proportion of patients who undergo delivery by cesarean section | < 48 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Nelson, MD, PhD | Contact | 6155875832 | rnelso25@uthsc.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional One Health Outpatient Center | Recruiting | Memphis | Tennessee | 38103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 26859467 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2022 | Aug 3, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Traditional positioning | Other | 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. |
|
| Regional One Health | Recruiting | Memphis | Tennessee | 38103 | United States |
|
| Regional One Health - Hollywood Clinic | Recruiting | Memphis | Tennessee | 38108 | United States |
|
| Regional One Health - Kirby Primary Care Clinic | Recruiting | Memphis | Tennessee | 38119 | United States |
|
| 29510425 | Background | 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. |
| 31600716 | Background | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided