LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40

Status unconfirmed · Not applicable

Conditions studied: Obesity, Morbid, Labor Pain

In brief

The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are: * Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement? * Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.

Key facts

Study ID

NCT06305260

Run by

MetroHealth Medical Center

People needed

150

Starts

2023-11-01

Expected to finish

2024-12-30

Last updated by the study team

2024-03-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 18 years or older
• English Speaking
• BMI (Body Mass Index) > 40
• Ability to provide informed consent and verbally disclose their medical history

You may not qualify if…

• History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement
• Patients with platelet counts <70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.
• Minors
• Adults unable to make their own decisions or with cognitive issues or developmental delays
• Prisoners

Where it is running

• MetroHealth Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.