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NCT Number: NCT05250960

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

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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Key information

Conditions

Hypotension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Labor Complication Obstetric Labor Complications Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCD

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

Primary outcomes

  1. Hypotension

    Time frame: 1 hour

    SBP <90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)

  2. Category II Tracings

    Time frame: 1 hour

    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'

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Evaluating the Use of Pre-epidural Placement of Sequential Compression Devices (SCD) to Prevent Hypotension

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2022
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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