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Lumbar Ultrasound for Obesity in Labor (LOTUS Trial)
N/A
Waitlist Available
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post-epidural
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using a pre-procedural lumbar ultrasound is better than the traditional method of palpation for placing epidurals in obese pregnant patients. They want to know if using
Who is the study for?
This trial is for pregnant individuals with a BMI over 40 who are experiencing labor pain and need an epidural. It's not specified who can't join, but typically those with conditions affecting the spine or certain infections might be excluded.
What is being tested?
The LOTUS Trial is testing if using lumbar ultrasound before placing an epidural in obese patients is better than the usual method of feeling by hand (palpation). Participants will be randomly assigned to one of these two methods.
What are the potential side effects?
Lumbar ultrasound itself has no significant side effects, but general risks associated with epidurals include soreness where the needle goes in, headache, or difficulty urinating.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of epidural
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of epidural
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Epidural Redirects
Secondary study objectives
Epidural replacement rate
Number of attempts at a different level
Patient satisfaction
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pre-procedural Lumbar UltrasoundExperimental Treatment1 Intervention
This group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement.
Group II: Traditional Lumbar PalpationActive Control1 Intervention
This group will include parturients who are randomized to traditional lumbar palpation prior to epidural placement. This is the current standard of care.
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Who is running the clinical trial?
MetroHealth Medical CenterLead Sponsor
120 Previous Clinical Trials
21,926 Total Patients Enrolled