Leg Elevation to Prevent Hypotension During Labor

TriHealth

Status: Completed

Conditions: Hypotension; Labor Complication

Treatments: Other: Leg Elevation

Study type: Interventional

Funder types: Other

Identifiers

NCT05674838

22-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Experimental Intervention - Leg Elevation Arm

Experimental group

Description:

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.

Treatment:

Other: Leg Elevation

Control - No Leg Elevation Arm

No Intervention group

Description:

Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes.