Trial Outcomes & Findings for Pannus Assistance Needed for Obstetric Ultrasound Studies (NCT NCT05764408)

NCT ID: NCT05764408

Last Updated: 2024-11-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: through study completion, an average of 1 day per participant
• Results posted on: 2024-11-07

Participant Flow

Participant milestones

Measure	Retractor Anatomy ultrasound performed with panniculus retractor	Control Anatomy ultrasound performed through usual protocol without a retractor
Overall Study STARTED	74	76
Overall Study COMPLETED	74	76
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor	Total n=150 Participants Total of all reporting groups
Age, Continuous	28.3 years STANDARD_DEVIATION 5.27 • n=74 Participants	28.9 years STANDARD_DEVIATION 4.63 • n=76 Participants	28.6 years STANDARD_DEVIATION 4.95 • n=150 Participants
Sex/Gender, Customized Pregnant	74 Participants n=74 Participants	76 Participants n=76 Participants	150 Participants n=150 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Insurance status Private	32 Participants n=74 Participants	28 Participants n=76 Participants	60 Participants n=150 Participants
Insurance status Public	37 Participants n=74 Participants	36 Participants n=76 Participants	73 Participants n=150 Participants
Insurance status Private and public	3 Participants n=74 Participants	8 Participants n=76 Participants	11 Participants n=150 Participants
Insurance status Other	1 Participants n=74 Participants	0 Participants n=76 Participants	1 Participants n=150 Participants
Insurance status None	1 Participants n=74 Participants	4 Participants n=76 Participants	5 Participants n=150 Participants
Tobacco use	5 Participants n=74 Participants	7 Participants n=76 Participants	12 Participants n=150 Participants
Diabetes mellitus Pregestational	4 Participants n=74 Participants	7 Participants n=76 Participants	11 Participants n=150 Participants
Diabetes mellitus Gestational	8 Participants n=74 Participants	5 Participants n=76 Participants	13 Participants n=150 Participants
Diabetes mellitus None	62 Participants n=74 Participants	64 Participants n=76 Participants	126 Participants n=150 Participants
Prior cesarean delivery Yes	27 Participants n=74 Participants	18 Participants n=76 Participants	45 Participants n=150 Participants
Prior cesarean delivery No	47 Participants n=74 Participants	58 Participants n=76 Participants	105 Participants n=150 Participants
Other abdominal surgery Yes	23 Participants n=74 Participants	15 Participants n=76 Participants	38 Participants n=150 Participants
Other abdominal surgery No	51 Participants n=74 Participants	61 Participants n=76 Participants	112 Participants n=150 Participants
Nulliparous Yes	19 Participants n=74 Participants	23 Participants n=76 Participants	42 Participants n=150 Participants
Nulliparous No	55 Participants n=74 Participants	53 Participants n=76 Participants	108 Participants n=150 Participants
Cephalic presentation Yes	30 Participants n=74 Participants	33 Participants n=76 Participants	63 Participants n=150 Participants
Cephalic presentation No	44 Participants n=74 Participants	43 Participants n=76 Participants	87 Participants n=150 Participants
Gestational age at ultrasound, weeks	20.6 Weeks STANDARD_DEVIATION 0.72 • n=74 Participants	20.4 Weeks STANDARD_DEVIATION 0.74 • n=76 Participants	20.5 Weeks STANDARD_DEVIATION 0.73 • n=150 Participants
Waist circumference, inches	56.8 inches STANDARD_DEVIATION 5.20 • n=74 Participants	56.4 inches STANDARD_DEVIATION 4.41 • n=76 Participants	56.6 inches STANDARD_DEVIATION 4.81 • n=150 Participants
Body mass index, kg/m^2	46.7 kg/m^2 STANDARD_DEVIATION 5.04 • n=74 Participants	46.2 kg/m^2 STANDARD_DEVIATION 5.00 • n=76 Participants	46.5 kg/m^2 STANDARD_DEVIATION 5.02 • n=150 Participants
Panniculus grade 1	34 Participants n=74 Participants	50 Participants n=76 Participants	84 Participants n=150 Participants
Panniculus grade 2	38 Participants n=74 Participants	23 Participants n=76 Participants	61 Participants n=150 Participants
Panniculus grade 3	2 Participants n=74 Participants	3 Participants n=76 Participants	5 Participants n=150 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor
Completion Rate of 16 Prespecified Views	19 Participants	24 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor
Completion Rate of All 64 Views	10 Participants	12 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor
Duration of Ultrasound Exam	34.9 minutes Standard Deviation 10.46	33.7 minutes Standard Deviation 11.24

SECONDARY outcome

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

Per EUROCAT guidelines

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor
Detection of Major Fetal Anomalies	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control Anatomy ultrasound performed through usual protocol without a retractor
Depth to Amniotic Cavity Before retractor	5.0 centimeters Standard Deviation 1.64	—
Depth to Amniotic Cavity After retractor	5.0 centimeters Standard Deviation 1.71	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor
Adverse Effects Skin irritation	0 Participants	1 Participants
Adverse Effects Allergic reaction	0 Participants	0 Participants
Adverse Effects Fetal demise	0 Participants	0 Participants
Adverse Effects Hospital admission	1 Participants	0 Participants
Adverse Effects None	73 Participants	75 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor
Sonographer Survey I experienced pain in my arm, shoulder, and/or wrist while performing this ultrasound	3.7 score on a scale Standard Deviation 1.21	3.9 score on a scale Standard Deviation 1.03
Sonographer Survey The participant's body habits affected my ability to complete the ultrasound	4.1 score on a scale Standard Deviation 1.05	4.3 score on a scale Standard Deviation 0.94
Sonographer Survey I feel confident about the quality of ultrasound images obtained	3.8 score on a scale Standard Deviation 0.99	3.6 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Retractor n=74 Participants Anatomy ultrasound performed with panniculus retractor	Control n=76 Participants Anatomy ultrasound performed through usual protocol without a retractor
Participant Survey I felt comfortable during the ultrasound	4.6 score on a scale Standard Deviation 0.84	4.8 score on a scale Standard Deviation 0.44
Participant Survey I am satisfied with the quality of ultrasound pictures I received	4.6 score on a scale Standard Deviation 0.70	4.5 score on a scale Standard Deviation 0.60
Participant Survey I enjoyed the ultrasound experience today	4.6 score on a scale Standard Deviation 0.69	4.7 score on a scale Standard Deviation 0.52

Adverse Events

Retractor

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Retractor n=74 participants at risk Anatomy ultrasound performed with panniculus retractor	Control n=76 participants at risk Anatomy ultrasound performed through usual protocol without a retractor
Social circumstances Hospital admission	1.4% 1/74 • Same day as ultrasound	0.00% 0/76 • Same day as ultrasound

Other adverse events

Measure	Retractor n=74 participants at risk Anatomy ultrasound performed with panniculus retractor	Control n=76 participants at risk Anatomy ultrasound performed through usual protocol without a retractor
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/74 • Same day as ultrasound	1.3% 1/76 • Same day as ultrasound

Additional Information

Dr. Melissa Wise

Prisma Health

Phone: 8644551600

Email: melissa.wise2@prismahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place