Pannus Assistance Needed for Obstetric Ultrasound Studies

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05764408

Enrollment

150

Registered

2023-03-10

Start date

2023-03-10

Completion date

2023-07-13

Last updated

2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Anomaly, Obesity Complicating Childbirth

Keywords

Obesity, Fetal ultrasound, Fetal anatomy, Pannus

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.

Interventions

DEVICEtraxi® Panniculus Retractor

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

Size of varying blocks used within the permuted block design randomization will be masked to investigators. Efforts will be made to mask the physician who is interpreting the ultrasound from participant allocation; the participant and sonographer will be asked not to disclose the study arm to the interpreting physician, and no ultrasound images that would reveal study group allocation will be saved for the physician's view.

Eligibility

Sex/Gender

FEMALE

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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).
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Retractor Anatomy ultrasound performed with panniculus retractor	74
Control Anatomy ultrasound performed through usual protocol without a retractor	76
Total	150

Baseline characteristics

Characteristic	Retractor	Control	Total
Age, Continuous	28.3 years STANDARD_DEVIATION 5.27	28.9 years STANDARD_DEVIATION 4.63	28.6 years STANDARD_DEVIATION 4.95
Body mass index, kg/m^2	46.7 kg/m^2 STANDARD_DEVIATION 5.04	46.2 kg/m^2 STANDARD_DEVIATION 5	46.5 kg/m^2 STANDARD_DEVIATION 5.02
Cephalic presentation No	44 Participants	43 Participants	87 Participants
Cephalic presentation Yes	30 Participants	33 Participants	63 Participants
Diabetes mellitus Gestational	8 Participants	5 Participants	13 Participants
Diabetes mellitus None	62 Participants	64 Participants	126 Participants
Diabetes mellitus Pregestational	4 Participants	7 Participants	11 Participants
Gestational age at ultrasound, weeks	20.6 Weeks STANDARD_DEVIATION 0.72	20.4 Weeks STANDARD_DEVIATION 0.74	20.5 Weeks STANDARD_DEVIATION 0.73
Insurance status None	1 Participants	4 Participants	5 Participants
Insurance status Other	1 Participants	0 Participants	1 Participants
Insurance status Private	32 Participants	28 Participants	60 Participants
Insurance status Private and public	3 Participants	8 Participants	11 Participants
Insurance status Public	37 Participants	36 Participants	73 Participants
Nulliparous No	55 Participants	53 Participants	108 Participants
Nulliparous Yes	19 Participants	23 Participants	42 Participants
Other abdominal surgery No	51 Participants	61 Participants	112 Participants
Other abdominal surgery Yes	23 Participants	15 Participants	38 Participants
Panniculus grade 1	34 Participants	50 Participants	84 Participants
Panniculus grade 2	38 Participants	23 Participants	61 Participants
Panniculus grade 3	2 Participants	3 Participants	5 Participants
Prior cesarean delivery No	47 Participants	58 Participants	105 Participants
Prior cesarean delivery Yes	27 Participants	18 Participants	45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Sex/Gender, Customized Pregnant	74 Participants	76 Participants	150 Participants
Tobacco use	5 Participants	7 Participants	12 Participants
Waist circumference, inches	56.8 inches STANDARD_DEVIATION 5.2	56.4 inches STANDARD_DEVIATION 4.41	56.6 inches STANDARD_DEVIATION 4.81

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 74	0 / 76
other Total, other adverse events	0 / 74	1 / 76
serious Total, serious adverse events	1 / 74	0 / 76

Outcome results

Primary

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.