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

NCT05250960 | Completed Results FDA Device

• 1 other identifier: 21-020
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypotension; Labor Complication

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention - SCD arm

EXPERIMENTAL

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

Control - no SCD arm

NO INTERVENTION

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

Interventions

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

Intervention - SCD arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Laboring women only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboring at Bethesda North Hospital Labor \& Delivery Unit
• Will receive epidural analgesia
• + weeks gestation
• Singleton pregnancy
• Category 1 tracings only before epidural placement

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Hypotension; Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Rachel Baker
• Organization: TriHealth

Rachel_Baker2@trihealth.com

513-569-6191

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: February 22, 2022
• Study Start: September 16, 2021
• Primary Completion: January 30, 2024
• Study Completion: February 27, 2024
• Last Updated: April 25, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)