Pannus Assistance Needed for Obstetric Ultrasound Studies

Fetal Anomaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764408
• Other study ID #: 2012318-1
• Status: Completed
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: July 13, 2023

Study information

• Verified date: March 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 13, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Anomaly
• Obesity Complicating Childbirth

Intervention

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.

Locations

Country	Name	City	State
United States	Prisma Health	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Clemson University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

Obesity in Pregnancy: ACOG Practice Bulletin, Number 230. Obstet Gynecol. 2021 Jun 1;137(6):e128-e144. doi: 10.1097/AOG.0000000000004395. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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