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Completed

NCT Number: NCT05764408

Pannus Assistance Needed for Obstetric Ultrasound Studies

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?

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Key information

Conditions

Obesity Complicating Childbirth Body Weight Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fetal Anomaly Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traxi® Panniculus Retractor

Device

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.

Primary outcomes

  1. Completion Rate of 16 Prespecified Views

    Time frame: 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 outcomes

  1. Completion Rate of All 64 Views

    Time frame: 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.

  2. Duration of Ultrasound Exam

    Time frame: 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

  3. Detection of Major Fetal Anomalies

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

    Per EUROCAT guidelines

  4. Depth to Amniotic Cavity

    Time frame: 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.

  5. Adverse Effects

    Time frame: 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.

  6. Sonographer Survey

    Time frame: 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).

  7. Participant Survey

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Clemson University

Registry information

Official study title

Pannus Assistance Needed for Obstetric Ultrasound Studies: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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