Pre-epidural SCDs 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 SCDs 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 receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs

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 SCDs 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 receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs Outcome variables include occurrence of maternal hypotension or Category II fetal tracings in the first hour after epidural placement.

Official Title
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Evaluating the Use of Pre-epidural Placement of SCDs to Prevent Hypotension

Conditions
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Hypotension, Labor Complication

Intervention / Treatment
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* Device: SCD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laboring at Bethesda North Hospital Labor & Delivery Unit Will receive epidural analgesia 37+ weeks gestation Singleton pregnancy Category 1 tracings only before epidural placement Exclusion Criteria: Under 18 years old Does not speak English Unable to consent to involvement in the research study Diagnosed with fetal demise Diagnosis of pre-existing hypertension Diagnosis of gestational hypertension Diagnosis of pre-eclampsia Diagnosis of diabetes Breech presentation Contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.) Contraindications to receiving 1L of LR Blood pressure on admission SBP>160 or DBP>110 Fetal heart rate abnormalities before epidural

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: Intervention - SCD arm<br>Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement | Device: SCD<br>* Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement<br>|
| No Intervention: Control - no SCD arm<br>Patient will receive 1L of LR during and after epidural placement with no use of SCDs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer) | 1 hour | 
| Category II tracings | Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not Category II tracings - The classification of Category II tracings includes the following: bradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders' | 1 hour |