Ultrasound High BMI Study (NCT05052658) | Clinical Trial Compass
CompletedNot Applicable
Ultrasound High BMI Study
United States23 participantsStarted 2021-10-27
Plain-language summary
This is a prospective experimental pilot study of full-term non-emergent obese parturients whose labor is being managed with epidural anesthesia to determine if neuraxial block placement with pre-procedure handheld ultrasound affects time to placement or number of needle passes. Approximately 25 patients, presenting for delivery at the University of Kentucky HealthCare Obstetrics Department, will be randomized to either the ultrasound or palpation group, between study approval and 31 July 2022.
Who can participate
Age range
18 Years – 50 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:
* Subject requesting and consenting for a labor epidural, aged 18-50 and BMI between 35-59.9 at admission for labor.
* Subject with American Society of Anesthesiologists score equal to or less than III.
* Subject with singleton gestation equal to or greater than 37 weeks.
* Subjects with planned labor epidural in sitting position.
Exclusion Criteria:
* Patients with urgent or emergent diagnoses involving the health of the patient or child, such as abnormal fetal heart tracing.
* Patients with major back abnormalities (back surgery, significant scoliosis).
* Patients with contra-indication to neuraxial block (bleeding risk, local anesthetic allergy).
* Patients having cesarean section or combined spinal epidural.
* Patients whose epidurals are performed by residents in first month of obstetric rotation and/or having performed fewer than 20 labor epidurals in total.
* Patient needing a translator for procedure.
* Patients who are 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.
What they're measuring
1
Time to placement of neuraxial block in parturients with BMI=35-59.9
Timeframe: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour
2
Number of passes to placement of neuraxial block in parturients with BMI=35-59.9
Timeframe: Time from start of epidural procedure to placement of epidural needle, not to exceed more than1 hour