Status:
COMPLETED
Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor
Lead Sponsor:
TriHealth Inc.
Conditions:
Hypotension
Labor Complication
Eligibility:
FEMALE
18+ years
Phase:
NA
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 control...
Detailed 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 control...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT05250960
Start Date
September 16 2021
End Date
February 27 2024
Last Update
April 25 2025
Active Locations (1)
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1
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242