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SCDs to Prevent Hypotension During Labor
N/A
Waitlist Available
Research Sponsored by TriHealth Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
37+ weeks gestation
Will receive epidural analgesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour
Awards & highlights
Study Summary
This trial will examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia.
Who is the study for?
This trial is for women over 18, in labor at Bethesda North Hospital, who are at least 37 weeks pregnant with a single baby and plan to get an epidural. They must have normal fetal heart rate patterns before the epidural and can't have high blood pressure, diabetes, or conditions that prevent leg compression or receiving fluids.Check my eligibility
What is being tested?
The study compares two groups: one receives SCDs (leg compression devices) plus fluids before getting an epidural to see if it prevents low blood pressure; the other just gets fluids without SCDs during and after the epidural.See study design
What are the potential side effects?
There may be discomfort from wearing SCDs on the legs. The risks are minimal but could include skin irritation or minor bruising where the device wraps around your legs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 37 weeks or more into my pregnancy.
Select...
I will be getting pain relief through an epidural.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Category II tracings
Hypotension
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - SCD armExperimental Treatment1 Intervention
Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
Group II: Control - no SCD armActive Control1 Intervention
Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SCD
2020
N/A
~430
Find a Location
Who is running the clinical trial?
TriHealth Inc.Lead Sponsor
95 Previous Clinical Trials
50,848 Total Patients Enrolled
1 Trials studying Labor Complications
300 Patients Enrolled for Labor Complications
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Intervention - SCD arm
- Group 2: Control - no SCD arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients still being enrolled in the trial?
"Per the details on clinicaltrials.gov, this medical trial has suspended recruitment of patients. It was first announced on September 16th 2021 and last amended August 31st 2022. While no longer accepting applications, there are 122 other studies that remain open to enrollees at present."
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