Pannus Assistance Needed for Obstetric Ultrasound Studies (PANOUS)

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

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?

Study Overview

• Status: Completed
• Conditions: Obesity Complicating Childbirth; Fetal Anomaly
• Intervention / Treatment: Device: traxi® Panniculus Retractor

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patti Parker, BSN, RN; Phone Number: 864-455-1510; Email: patti.parker@prismahealth.org

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: traxi® 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.
No Intervention: No retractor; The detailed anatomic survey will proceed per normal protocol. Approaches may include transabdominal and transvaginal imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate visualization of sixteen prespecified fetal anatomy ultrasound components	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.	through study completion, an average of 1 day per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sonographer experience	A survey will be administered to the sonographer performing the anatomy ultrasound for each participant. The sonographer will be asked to complete the survey immediately after the ultrasound exam. The following questions will be asked with Likert scale responses ranging from strongly disagree to strongly agree: I experienced pain in my arm, shoulder and/or wrist while performing this ultrasound; The participant's body habitus affected my ability to complete the ultrasound; I feel confident about the quality of ultrasound images obtained; The use of a pannus retractor made the ultrasound easier to perform; It was easy to apply the pannus retractor	through study completion, an average of 1 day per participant
Participant experience	A survey will be administered to the participants immediately after the ultrasound concludes. The following questions will be asked with Likert scale responses ranging from strongly disagree to strongly agree: I felt comfortable during the ultrasound; I am satisfied with the quality of ultrasound pictures I received; I enjoyed the ultrasound experience today; I would be willing to have future ultrasounds performed with the retractor adhesive in place	through study completion, an average of 1 day per participant
Adequate visualization of all fetal anatomy ultrasound components	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.	through study completion, an average of 1 day per participant
Detection of fetal anomalies	The ultrasound reports' individual fields and summary will be reviewed to determine if a fetal anomaly was suspected or confirmed during the encounter. The name of the anomaly or anomalies will be recorded.	through study completion, an average of 1 day per participant
Skin to amniotic cavity depth	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 pannus. The measure will be repeated for the intervention group once the pannus retractor is in place.	through study completion, an average of 1 day per participant
Duration of ultrasound exam	The time from first to last ultrasound image acquisition will be recorded. The time it takes to place the retractor will also be recorded.	through study completion, an average of 1 day per participant
Adverse effects	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.	through study completion, an average of 1 day per participant

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Clemson University
• Investigators: Principal Investigator: Daniel Pasko, MD, Prisma Health

Publications and helpful links

General Publications

• Stothard KJ, Tennant PW, Bell R, Rankin J. Maternal overweight and obesity and the risk of congenital anomalies: a systematic review and meta-analysis. JAMA. 2009 Feb 11;301(6):636-50. doi: 10.1001/jama.2009.113.
• Dashe JS, McIntire DD, Twickler DM. Effect of maternal obesity on the ultrasound detection of anomalous fetuses. Obstet Gynecol. 2009 May;113(5):1001-1007. doi: 10.1097/AOG.0b013e3181a1d2f5.
• Thornburg LL, Miles K, Ho M, Pressman EK. Fetal anatomic evaluation in the overweight and obese gravida. Ultrasound Obstet Gynecol. 2009 Jun;33(6):670-5. doi: 10.1002/uog.6401.
• Racusin D, Stevens B, Campbell G, Aagaard KM. Obesity and the risk and detection of fetal malformations. Semin Perinatol. 2012 Jun;36(3):213-21. doi: 10.1053/j.semperi.2012.05.001.
• AIUM Practice Parameter for the Performance of Detailed Second- and Third-Trimester Diagnostic Obstetric Ultrasound Examinations. J Ultrasound Med. 2019 Dec;38(12):3093-3100. doi: 10.1002/jum.15163. No abstract available.
• Weichert J, Hartge DR. Obstetrical sonography in obese women: a review. J Clin Ultrasound. 2011 May;39(4):209-16. doi: 10.1002/jcu.20767. Epub 2010 Dec 7.
• Pasko DN, Wood SL, Jenkins SM, Owen J, Harper LM. Completion and Sensitivity of the Second-Trimester Fetal Anatomic Survey in Obese Gravidas. J Ultrasound Med. 2016 Nov;35(11):2449-2457. doi: 10.7863/ultra.15.11057. Epub 2016 Oct 3.
• Bagley JE, Barnett J, Anderson MP. On-the-Job Pain and Injury as Related to Adaptive Ergonomic Equipment in the Sonographer's Workplace and Area. Journal of Diagnostic Medical Sonography, 2016. 33(1): 15-21.
• Iglesias M, Butron P, Abarca L, Perez-Monzo MF, de Rienzo-Madero B. An anthropometric classification of body contour deformities after massive weight loss. Ann Plast Surg. 2010 Aug;65(2):129-34. doi: 10.1097/SAP.0b013e3181c9c336.
• Hendler I, Blackwell SC, Bujold E, Treadwell MC, Wolfe HM, Sokol RJ, Sorokin Y. The impact of maternal obesity on midtrimester sonographic visualization of fetal cardiac and craniospinal structures. Int J Obes Relat Metab Disord. 2004 Dec;28(12):1607-11. doi: 10.1038/sj.ijo.0802759.
• Obesity in Pregnancy: ACOG Practice Bulletin, Number 230. Obstet Gynecol. 2021 Jun 1;137(6):e128-e144. doi: 10.1097/AOG.0000000000004395.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): July 13, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Fetal ultrasound; Fetal anatomy; Pannus
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2012318-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No