Pannus Assistance Needed for Obstetric Ultrasound Studies

NCT05764408 | Completed Results

• 1 other identifier: 2012318-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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?

Conditions

Obesity Complicating Childbirth; Fetal Anomaly

Keywords

Obesity; Fetal ultrasound; Fetal anatomy; Pannus

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 day per participant

Secondary Outcomes (7)

• Completion Rate of All 64 Views

  through study completion, an average of 1 day per participant

• Duration of Ultrasound Exam

  through study completion, an average of 1 day per participant

• Detection of Major Fetal Anomalies

  through study completion, an average of 1 day per participant

• Depth to Amniotic Cavity

  through study completion, an average of 1 day per participant

• Adverse Effects

  through study completion, an average of 1 day per participant

Study Arms (2)

Retractor

EXPERIMENTAL

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

No retractor

NO INTERVENTION

The detailed anatomic survey will proceed per normal protocol. Approaches may include transabdominal and transvaginal imaging.

Interventions

traxi® Panniculus Retractor DEVICE

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.

Retractor

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Clemson University: collaborator

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (12)

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

  PMID: 34011890 BACKGROUND

• 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.

  PMID: 31736130 BACKGROUND

• 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.

  PMID: 21480286 BACKGROUND

• 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.

  PMID: 19384114 BACKGROUND

• 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.

  PMID: 19479682 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20606587 BACKGROUND

• 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.

  PMID: 19211471 BACKGROUND

• 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.

  PMID: 22713503 BACKGROUND

• 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.

  PMID: 27698181 BACKGROUND

• 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.

  PMID: 15303105 BACKGROUND

• Wise ML, Okon M, Pratt KN, Lane AS, Carlson LM, Eichelberger KY, Crockett AH, Zhang L, Pasko DN. Panniculus Retractor Use for Visualization of Fetal Anatomy: A Randomized Controlled Trial. Obstet Gynecol. 2024 Sep 1;144(3):403-410. doi: 10.1097/AOG.0000000000005689. Epub 2024 Jul 25.

  PMID: 39053011 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities; Obesity

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Melissa Wise
• Organization: Prisma Health

melissa.wise2@prismahealth.org

8644551600

Study Officials

• Daniel Pasko, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: March 10, 2023
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)