TerminatedNot Applicable

3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient

Stopped: The study device is not working, and there is no funding available to purchase or rent a new one.

United States40 participantsStarted 2018-02-20

Plain-language summary

This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device).

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: * American Society of Anesthesiologists physical status class I, II, or III. * Term pregnancy. * Requesting epidural analgesia for anticipated vaginal delivery. * BMI\>or = 40. Exclusion Criteria: * Contraindication for epidural analgesia * Inability to adequately understand the consent form. * Incarcerated patients. * Patients with known spinal deformities. * Allergies to ultrasound gel. * Allergies to local anesthetics

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

Number of Needle Insertion Attempts Calculated Across All Participants

Timeframe: Beginning of needle insertion till catheter placement-15 minutes

Number of Participants With Successful Epidural Catheter Placements

Timeframe: Within first 90 minutes following catheter placement

Number of Needle Insertion Redirections Calculated Across All Participants

Timeframe: Beginning of needle insertion till catheter placement-15 minutes

Trial details

NCT IDNCT03405311

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-11

Results submitted2025-03-17

View on ClinicalTrials.gov More Obesity, Morbid trials

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.

What they're measuring

Number of Needle Insertion Attempts Calculated Across All Participants

Timeframe: Beginning of needle insertion till catheter placement-15 minutes

Number of Participants With Successful Epidural Catheter Placements

Timeframe: Within first 90 minutes following catheter placement

Number of Needle Insertion Redirections Calculated Across All Participants

Timeframe: Beginning of needle insertion till catheter placement-15 minutes