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

Sponsor
University of Tennessee Health Science Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05489315
Collaborator
(none)
400
4
2
21.7
100
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Positioning with peanut ball
  • Other: Traditional positioning
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
May 19, 2023
Anticipated Study Completion Date :
May 19, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: 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.

Experimental: Peanut Ball Positioning

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

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Rate of active stage of labor [Expected <6 hours]

    Length of time from progression of 6cm cervical dilation to 10cm

Secondary Outcome Measures

  1. Cesarean section rate [< 48 hours]

    Proportion of patients who undergo delivery by cesarean section

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regional One Health Outpatient Center Memphis Tennessee United States 38103
2 Regional One Health Memphis Tennessee United States 38103
3 Regional One Health - Hollywood Clinic Memphis Tennessee United States 38108
4 Regional One Health - Kirby Primary Care Clinic Memphis Tennessee United States 38119

Sponsors and Collaborators

  • University of Tennessee Health Science Center

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Rachel Nelson, Co-Principal Investigator, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier:
NCT05489315
Other Study ID Numbers:
  • 21-08072-FB
First Posted:
Aug 5, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rachel Nelson, Co-Principal Investigator, University of Tennessee Health Science Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022