Pannus Assistance Needed for Obstetric Ultrasound Studies

Not Applicable

Completed

Conditions: Obesity Complicating Childbirth
Fetal Anomaly

Interventions: Device: traxi® Panniculus Retractor

Registration Number: NCT05764408

Lead Sponsor: Prisma Health-Upstate

Brief 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?

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 150

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retractor	traxi® Panniculus Retractor	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.

Primary Outcome Measures

Name	Time	Method
Completion Rate of 16 Prespecified Views	through study completion, an average of 1 day per participant	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.

Secondary Outcome Measures

Name	Time	Method
Completion Rate of All 64 Views	through study completion, an average of 1 day per participant	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.
Duration of Ultrasound Exam	through study completion, an average of 1 day per participant	The time from first to last ultrasound image acquisition, time for retractor placement not included
Detection of Major Fetal Anomalies	through study completion, an average of 1 day per participant	Per EUROCAT guidelines
Depth to Amniotic Cavity	through study completion, an average of 1 day per participant	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.
Adverse Effects	through study completion, an average of 1 day per participant	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.
Sonographer Survey	through study completion, an average of 1 day per participant	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).
Participant Survey	through study completion, an average of 1 day per participant	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).