N/A
Completed N=109
Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor
Hypotension · Labor Complication
Source: ClinicalTrials.gov NCT05250960 ↗
Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Hypotension — 4; 4 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypotension |
4; 4 | — |
| PRIMARY Category II Tracings |
17; 13 | — |
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
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. Informational only — not medical advice.