Leg Elevation to Prevent Hypotension During Labor

Not Applicable

• Conditions: Hypotension; Labor Complication
• Interventions: Other: Leg Elevation

• Registration Number: NCT05674838
• Lead Sponsor: TriHealth Inc.

Brief 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.

Study Timeline

• Study Start: 2022-10-29
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Laboring at Good Samaritan Hospital Labor & Delivery Unit
• 37+ weeks gestation
• Planned vaginal delivery
• Planned epidural analgesia

Exclusion Criteria

• Under 18 years old
• Does not speak English
• Unable to consent to involvement in the research study
• Attended less than 3 prenatal care office visits
• Diagnosed with fetal demise
• Diagnosed with fetal anomalies
• Contraindications to both legs being elevated (ex: fractured bones, lower limb amputation, etc.)
• Contraindications to receiving 1L of IV fluids
• Requiring IV hypertensive medications
• Requiring IV magnesium

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Intervention - Leg Elevation Arm	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.

Primary Outcome Measures

Name	Time	Method
Maternal Hypotension	40 minutes	SBP requiring treatment by the anesthesia provider
Late or Prolonged Decelerations	40 minutes	Any late or prolonged decelerations on the fetal heart tracings

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States