N/A N=109 Randomized Prevention

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

Hypotension · Labor Complication

Bottom Line

View on ClinicalTrials.gov: NCT05250960 ↗

Enrolled (actual)

109

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Hypotension — 4; 4 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SCD (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: TriHealth Inc.
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Hypotension	4; 4	—
PRIMARY Category II Tracings	17; 13	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05250960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.