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 range16 Years

SexFEMALE

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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

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