Pannus Assistance Needed for Obstetric Ultrasound Studies

Prisma Health-Upstate

Status: Completed

Conditions: Fetal Anomaly; Obesity Complicating Childbirth

Treatments: Device: traxi® Panniculus Retractor

Study type: Interventional

Funder types: Other

Identifiers

NCT05764408

2012318-1

Details and patient eligibility

About

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?

Full description

Pregnancies complicated by obesity have an increased risk of multiple pregnancy complications, including structural fetal anomalies. Ultrasound is a critical tool for the detection of congenital anomalies; however, adequate visualization of fetal anatomy by ultrasound decreases as body mass index increases. Placing a pannus retractor adhesive is a simple intervention that redistributes adiposity, providing better access to an important acoustic window for fetal ultrasound.

The investigators will conduct a randomized controlled trial comparing outcomes between groups that undergo fetal anatomy ultrasound examinations with or without use of a pannus retractor adhesive. The adequacy of ultrasound visualization is the primary outcome of interest. Secondary outcomes of interest include sonographer pain perception, participant satisfaction, adequacy of all detailed anatomy views, detection of fetal anomalies, skin to amniotic cavity depth, duration of ultrasound exam, and adverse reactions.

Enrollment: 150 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Retractor

Experimental group

Description:

Research team members will apply a pannus retractor adhesive according to manufacturer's directions. The sonographer will be asked to attempt all views of the detailed anatomic survey before the adhesive is removed. If the sonographer thinks that additional views could be obtained with the adhesive removed using transabdominal or transvaginal imaging, this is acceptable based on the pragmatic design of this study.

Treatment:

Device: traxi® Panniculus Retractor

No retractor

No Intervention group

Description:

The detailed anatomic survey will proceed per normal protocol. Approaches may include transabdominal and transvaginal imaging.