Leg Elevation to Prevent Hypotension During Labor

Study Overview
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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.

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.

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

Conditions
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Hypotension, Labor Complication

Intervention / Treatment
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* Other: Leg Elevation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Intervention - Leg Elevation Arm<br>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. | Other: Leg Elevation<br>* 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.<br>|
| No Intervention: Control - No Leg Elevation Arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Hypotension | SBP requiring treatment by the anesthesia provider | 40 minutes | 
| Late or Prolonged Decelerations | Any late or prolonged decelerations on the fetal heart tracings | 40 minutes |