NCT05674838

Leg Elevation to Prevent Hypotension During Labor

Evaluation of the Use of Leg Elevation on a Peanut Ball to Prevent Hypotension Following Epidural Anesthesia in Laboring Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms: Arm 1: Patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. She'll remain in this position for approximately 40 minutes. Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation. She'll remain in this position for approximately 40 minutes.

Detailed description

When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms: Arm 1: Patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. She'll remain in this position for approximately 40 minutes. Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation. She'll remain in this position for approximately 40 minutes. Outcome variables include occurrence of maternal hypotension or late or prolonged decelerations within the first hour after epidural placement.

Conditions

• Hypotension
• Labor Complication

Interventions

Type	Name	Description
OTHER	Leg Elevation	Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes.

Timeline

• Start date: 2022-10-29
• Primary completion: 2025-05-29
• Completion: 2025-08-12
• First posted: 2023-01-09
• Last updated: 2025-08-29
• Results posted: 2025-08-29

Locations

1 site across 1 country: United States