Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor

TriHealth

Status: Completed

Conditions: Hypotension; Labor Complication

Treatments: Device: SCD

Study type: Interventional

Funder types: Other

Identifiers

NCT05250960

21-020

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 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

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 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.

Enrollment: 109 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Intervention - SCD arm

Experimental group

Description:

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

Treatment:

Device: SCD

Control - no SCD arm

No Intervention group

Description:

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