Leg Elevation to Prevent Hypotension During Labor

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-29

Study Completion Date

2025-08-12

Brief Summary

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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.

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Detailed Description

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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

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Hypotension Labor Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental Intervention - Leg Elevation Arm

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.

Group Type EXPERIMENTAL

Leg Elevation

Intervention Type OTHER

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.

Control - No Leg Elevation Arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes