Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study

NCT05527327 | Completed DMC

• 1 other identifier: 1935904-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancies complicated by obesity have an increased risk of multiple pregnancy complications, including structural fetal anomalies. Therefore, maternal obesity (BMI ≥30 kg/m2) is an indication for a detailed anatomic ultrasound examination. Ultrasound is a critical tool for the detection of congenital anomalies; however, obesity makes ultrasound examinations technically challenging. The primary objective of this ambidirectional cohort pilot study is to evaluate whether utilization of a pannus retractor is associated with increased rates of detailed anatomic ultrasound completion amongst pregnant patients with a body mass index (BMI) greater than or equal to 40 kg/m2. Retrospective data will be collected for 100 patients with a BMI of 40 kg/m2 or greater to assess the baseline rate of completion of 16 components of the detailed anatomic survey prior to the intervention. We plan to enroll 20 patients into a prospective pilot to the intervention arm. The intervention is placement of an adhesive medical device, the traxi® Panniculus Retractor (Laborie, Portsmouth, New Hampshire), which was developed for pannus retraction during cesarean section. Adequacy of anatomic ultrasound completion will be based upon 16 pre-defined views from the anatomic survey. Ultrasound completion rates from the prospective cohort of participants that undergo ultrasound evaluation using a pannus retractor will be compared to a historical cohort without pannus retractor use. We hypothesize that use of a pannus retractor for pregnant participants with BMI greater than or equal to 40 kg/m2 increases the rate of anatomical ultrasound completion.

Conditions

Obesity; Pregnancy Complications; Fetal Anomaly; Pannus

Keywords

obesity; pregnancy; pannus; ultrasound; fetal anomaly

Outcome Measures

Primary Outcomes (1)

• Complete ultrasound study (yes/no)

  The ultrasound report will be evaluated to determine if the following elements were adequately visualized: lateral ventricles, cerebellum, cavum septum pellucidum, face, four chamber view, right outflow tract, left outflow tract, three vessel view, three vessel trachea view, spine, ventral wall, umbilical cord, stomach, left kidney, right kidney, bladder. If any one or more of these elements are not adequately visualized, the study will be interpreted as "incomplete." The proportion of complete to incomplete studies will be compared between the retrospective and prospective cohorts.

  Up to one month from each individual's participation

Study Arms (1)

Prospective arm

EXPERIMENTAL

All prospective participants will be consented to use of the intervention, a pannus retractor at time of detailed obstetric ultrasound.

Device: traxi® Panniculus Retractor

Interventions

traxi® Panniculus Retractor DEVICE

This is an adhesive medical device designed to retract a pannus during cesarean section. It will be applied to prospective participants according to manufacturer instructions, just prior to the detailed anatomic ultrasound.

Prospective arm

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:

• Pregnant patients presenting for detailed anatomic ultrasound with a BMI of at least 40 kg/m2
• English or Spanish speaking
• BMI of at least 40.0 kg/m2 at first obstetric visit during this pregnancy
• Gestational age between 18 weeks 0 days to 23 weeks 6 days

You may not qualify if:

• Patients who have already had an anatomy ultrasound during the same pregnancy with our department
• History of tape/adhesive allergy
• Multifetal gestation
• Known intrauterine fetal demise

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (11)

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  PMID: 15142995 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

• 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

• 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

• Dashe JS, McIntire DD, Twickler DM. Maternal obesity limits the ultrasound evaluation of fetal anatomy. J Ultrasound Med. 2009 Aug;28(8):1025-30. doi: 10.7863/jum.2009.28.8.1025.

  PMID: 19643785 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

• 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

• Simmons PM, Wendel MP, Whittington JR, San Miguel K, Ounpraseuth ST, Magann EF. Accuracy and Completion Rate of the Fetal Anatomic Survey in the Super Obese Parturient. J Ultrasound Med. 2021 Oct;40(10):2047-2051. doi: 10.1002/jum.15582. Epub 2020 Dec 5.

  PMID: 33277924 BACKGROUND

MeSH Terms

Conditions

Obesity; Pregnancy Complications; Congenital Abnormalities

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Pasko, MD

  Prisma Health Maternal-Fetal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All prospective participants will receive the intervention for one occurrence. Retrospective participants' results will be observed without any intervention.

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: September 16, 2022
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)