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

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

Sponsors

Lead Sponsor: University of Tennessee Health Science Center

Source University of Tennessee Health Science Center
Brief 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.

Overall Status Recruiting
Start Date 2021-07-26
Completion Date 2023-05-19
Primary Completion Date 2023-05-19
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of active stage of labor Expected <6 hours
Secondary Outcome
Measure Time Frame
Cesarean section rate < 48 hours
Enrollment 400
Condition
Intervention

Intervention Type: Device

Intervention Name: Positioning with peanut ball

Description: 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.

Arm Group Label: Peanut Ball Positioning

Intervention Type: Other

Intervention Name: Traditional positioning

Description: 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.

Arm Group Label: Traditional Positioning

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Rachel Nelson, MD, PhD

Phone: 6155875832

Email: [email protected]

Location
Facility: Status: Contact:
Regional One Health Outpatient Center | Memphis, Tennessee, 38103, United States Recruiting Mary Butts, MD 901-515-3000
Regional One Health | Memphis, Tennessee, 38103, United States Recruiting Mary Butts, MD 901-275-3725
Regional One Health - Hollywood Clinic | Memphis, Tennessee, 38108, United States Recruiting Mary Butts, MD 901-515-5500
Regional One Health - Kirby Primary Care Clinic | Memphis, Tennessee, 38119, United States Recruiting Mary Butts 901-515-5350
Location Countries

United States

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Tennessee Health Science Center

Investigator Full Name: Rachel Nelson

Investigator Title: Co-Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Traditional Positioning

Type: Other

Description: 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.

Label: Peanut Ball Positioning

Type: Experimental

Description: Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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