Clinical trial NCT05764408: Pannus Assistance Needed for Obstetric Ultrasound Studies
Official title: Pannus Assistance Needed for Obstetric Ultrasound Studies: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Complicating Childbirth
Fetal Anomaly
Keywords: Obesity
Fetal ultrasound
Fetal anatomy
Pannus
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Clemson University
First posted: 2023-03-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion Rate of 16 Prespecified Views
timeFrame: through study completion, an average of 1 day per participant
Secondary outcomes:
measure: Completion Rate of All 64 Views
timeFrame: through study completion, an average of 1 day per participant
measure: Duration of Ultrasound Exam
timeFrame: through study completion, an average of 1 day per participant
measure: Detection of Major Fetal Anomalies
timeFrame: through study completion, an average of 1 day per participant
measure: Depth to Amniotic Cavity
timeFrame: through study completion, an average of 1 day per participant
measure: Adverse Effects
timeFrame: through study completion, an average of 1 day per participant
measure: Sonographer Survey
timeFrame: through study completion, an average of 1 day per participant
measure: Participant Survey
timeFrame: through study completion, an average of 1 day per participant
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Daniel Pasko, MD
role: PRINCIPAL_INVESTIGATOR
References:
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