CompletedNot Applicable

Pannus Assistance Needed for Obstetric Ultrasound Studies

United States150 participantsStarted 2023-03-10

Plain-language summary

The goal of this randomized controlled trial is to evaluate whether use of a pannus retractor adhesive improves fetal anatomic ultrasound examinations. The primary question it aims to answer is: • Does the use of a pannus retractor adhesive increase the rate of detailed anatomic survey completion, defined by satisfactory visualization of sixteen prespecified fetal anatomy views, for participants with a pannus and body mass index of at least 40 kg/m2?

Who can participate

Age range

16 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: * English or Spanish speaking * BMI of at least 40.0 kg/2, calculated within 6 months of conception or at the first obstetric visit * Pannus grade 1 or greater * Gestational age between 18 weeks 0 days to 23 weeks 6 days, confirmed by prior ultrasound assessment Exclusion Criteria: * Patients who have already had a routinely timed anatomy ultrasound during the same pregnancy with Prisma Health Maternal-Fetal Medicine * Patients with a known major fetal anomaly, confirmed by Prisma Health Maternal-Fetal Medicine * Tape/adhesive allergy * Multifetal gestation * Intrauterine fetal demise

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

Completion Rate of 16 Prespecified Views

Timeframe: through study completion, an average of 1 day per participant

Trial details

NCT IDNCT05764408

SponsorPrisma Health-Upstate

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-13

Results submitted2024-07-12

View on ClinicalTrials.gov More Obesity Complicating Childbirth trials