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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of epidural for reporting.

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 more

Awards & 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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