Pre-epidural Sequential Compression Devices (SCDs) 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

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-16

Study Completion Date

2024-02-27

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

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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 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 1liter (L) of lactated ringers (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.

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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Intervention - SCD arm

Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement

Group Type EXPERIMENTAL

SCD

Intervention Type DEVICE

Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement

Control - no SCD arm

Patient will receive 1L of LR during and after epidural placement with no use of SCDs

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SCD

Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement

Intervention Type DEVICE

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 systolic blood pressure (SBP)\>160 or diastolic blood pressure (DBP)\>110
* Fetal heart rate abnormalities before epidural

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes