LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40 (NCT06305260) | Clinical Trial Compass
UnknownNot Applicable
LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40
United States150 participantsStarted 2023-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years or older
* English Speaking
* BMI (Body Mass Index) \> 40
* Ability to provide informed consent and verbally disclose their medical history
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.