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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
traxi® Panniculus Retractor is a disposable adhesive medical device designed for surgical patients with a BMI of at least 30kg/m2, to retract a pannus cephalad and expose the lower abdomen. The device is like a large sticker or bandage, posing no more than minimal risk to participants. The adhesive will be applied to the abdomen according to manufacturer instructions, just prior to a participant's scheduled ultrasound. Once the ultrasound exam has ended, the adhesive will be immediately removed and discarded.
Prisma Health
Greenville, South Carolina, United States
Completion Rate of 16 Prespecified Views
Views including: brain (lateral ventricles, cerebellum, cavum), face, heart (four chamber view, right outflow tract, left outflow tract, three vessel view, three vessel trachea view), spine (cervical, thoracic, lumbar, sacrum, and spine shape will be summarized as one spine view), ventral wall, umbilical cord, stomach, left and right kidneys, and bladder.
Time frame: through study completion, an average of 1 day per participant
Completion Rate of All 64 Views
Views including: calvarium/cranium, intracranial anatomy, cavum, parenchyma, lateral ventricles, choroid plexus, cerebellum/vermis, cisterna magna, midline falx, cervical spine, thoracic spine, lumbar spine, sacral spine, spine shape/curvature, face, lips, neck, nuchal fold, nasal bone, palate, profile, orbits/eyes, mandible, maxilla, thoracic contour, lungs, four chamber view, cardiac activity, cardiac rhythm, cardiac situs, right outflow tract, left outflow tract, aortic arch, ductal arch, SVC, interventricular septum, cardiac axis, diaphragm, three vessel view, three vessel trachea view, IVC, crossing, ventral wall, cord insertion, situs, stomach, gallbladder, left kidney, right kidney, bladder, left humerus, right humerus, left forearm, right forearm, left hand, right hand, left femur, right femur, left lower leg, right lower leg, left foot, right foot, umbilical cord, genitalia.
Time frame: through study completion, an average of 1 day per participant
Duration of Ultrasound Exam
The time from first to last ultrasound image acquisition, time for retractor placement not included
Time frame: through study completion, an average of 1 day per participant
Detection of Major Fetal Anomalies
Per EUROCAT guidelines
Time frame: through study completion, an average of 1 day per participant
Depth to Amniotic Cavity
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Using only the minimal amount of pressure to create the image, the shortest mid-sagittal distance will be measured from the skin to the amniotic cavity above and below the panniculus. This is for the retractor group only.
Time frame: through study completion, an average of 1 day per participant
Adverse Effects
In addition to routine monitoring for all adverse effects, the following will be noted specifically: skin irritation, allergic reaction, maternal intolerance of pannus retractor adhesive, fetal demise, and hospital admission immediately following the ultrasound exam.
Time frame: through study completion, an average of 1 day per participant
Sonographer Survey
Immediately after the ultrasound exam, a survey was administered to the sonographer who performed the anatomy ultrasound for each participant. The questions were asked with Likert scale responses ranging from strongly disagree (1) to strongly agree (5).
Time frame: through study completion, an average of 1 day per participant
Participant Survey
Immediately after the ultrasound exam, a survey was administered to the participant. The questions were asked with Likert scale responses ranging from strongly disagree (1) to strongly agree (5).
Time frame: through study completion, an average of 1 day per participant