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| Name | Class |
|---|---|
| Clemson University | OTHER |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No retractor | No Intervention | The detailed anatomic survey will proceed per normal protocol. Approaches may include transabdominal and transvaginal imaging. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate of All 64 Views | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Pasko, MD | Prisma Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34011890 | Background | Obesity in Pregnancy: ACOG Practice Bulletin, Number 230. Obstet Gynecol. 2021 Jun 1;137(6):e128-e144. doi: 10.1097/AOG.0000000000004395. | |
| 31736130 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retractor | Anatomy ultrasound performed with panniculus retractor |
| FG001 | Control | Anatomy ultrasound performed through usual protocol without a retractor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retractor | Anatomy ultrasound performed with panniculus retractor |
| BG001 | Control | Anatomy ultrasound performed through usual protocol without a retractor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | through study completion, an average of 1 day per participant |
|
Same day as ultrasound
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retractor | Anatomy ultrasound performed with panniculus retractor | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission | Social circumstances | Non-systematic Assessment | Hospital admission following the ultrasound examination was collected for any medical reason. The one admission seen was for cervical insufficiency unrelated to the trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Wise | Prisma Health | 8644551600 | melissa.wise2@prismahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2023 | Jul 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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.
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|
| through study completion, an average of 1 day per participant |
| Duration of Ultrasound Exam | The time from first to last ultrasound image acquisition, time for retractor placement not included | through study completion, an average of 1 day per participant |
| Detection of Major Fetal Anomalies | Per EUROCAT guidelines | through study completion, an average of 1 day per participant |
| Depth to Amniotic Cavity | 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 panniculus. This is for the retractor group only. | 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 |
| Sonographer Survey | Immediately after the ultrasound exam, a survey was administered to the sonographer who performed the anatomy ultrasound for each participant. The questions were asked with Likert scale responses ranging from strongly disagree (1) to strongly agree (5). | through study completion, an average of 1 day per participant |
| Participant Survey | Immediately after the ultrasound exam, a survey was administered to the participant. The questions were asked with Likert scale responses ranging from strongly disagree (1) to strongly agree (5). | through study completion, an average of 1 day per participant |
| 21480286 | 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. |
| 19384114 | 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. |
| 19479682 | 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. |
| 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. |
| 20606587 | 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. |
| 19211471 | 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. |
| 22713503 | 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. |
| 27698181 | 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. |
| 15303105 | 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. |
| 39053011 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Insurance status | Count of Participants | Participants |
|
| Tobacco use | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Prior cesarean delivery | Count of Participants | Participants |
|
| Other abdominal surgery | Count of Participants | Participants |
|
| Nulliparous | Count of Participants | Participants |
|
| Cephalic presentation | Count of Participants | Participants |
|
| Gestational age at ultrasound, weeks | Mean | Standard Deviation | Weeks |
|
| Waist circumference, inches | Mean | Standard Deviation | inches |
|
| Body mass index, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| Panniculus grade | Panniculus grade was evaluated in a reclined, supine position. It was classified according to the system described by Iglesias et al.: no panniculus (grade 0), panniculus remaining above the inguinal ligament (grade 1), overhanging panniculus below the inguinal ligament but not surpassing the upper third of the thigh (grade 2), overhanging panniculus located within the middle third of the thigh (grade 3), overhanging panniculus within the lower third of the thigh (grade 4), overhanging panniculus below the knee (grade 5). Higher grades indicate a more significant panniculus presence. | Count of Participants | Participants |
|
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| Secondary | Completion Rate of All 64 Views | 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. | Posted | Count of Participants | Participants | through study completion, an average of 1 day per participant |
|
|
|
|
| Secondary | Duration of Ultrasound Exam | The time from first to last ultrasound image acquisition, time for retractor placement not included | Posted | Mean | Standard Deviation | minutes | through study completion, an average of 1 day per participant |
|
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|
|
| Secondary | Detection of Major Fetal Anomalies | Per EUROCAT guidelines | Posted | Count of Participants | Participants | through study completion, an average of 1 day per participant |
|
|
|
| Secondary | Depth to Amniotic Cavity | 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 panniculus. This is for the retractor group only. | Posted | Mean | Standard Deviation | centimeters | 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. | Posted | Count of Participants | Participants | through study completion, an average of 1 day per participant |
|
|
|
|
| Secondary | Sonographer Survey | Immediately after the ultrasound exam, a survey was administered to the sonographer who performed the anatomy ultrasound for each participant. The questions were asked with Likert scale responses ranging from strongly disagree (1) to strongly agree (5). | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 day per participant |
|
|
|
| Secondary | Participant Survey | Immediately after the ultrasound exam, a survey was administered to the participant. The questions were asked with Likert scale responses ranging from strongly disagree (1) to strongly agree (5). | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 1 day per participant |
|
|
|
| 74 |
| 1 |
| 74 |
| 0 |
| 74 |
| EG001 | Control | Anatomy ultrasound performed through usual protocol without a retractor | 0 | 76 | 0 | 76 | 1 | 76 |
|
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| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Private and public |
|
| Other |
|
| None |
|
| None |
|
| 3 |
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| Fetal demise |
|
| Hospital admission |
|
| None |
|
| I feel confident about the quality of ultrasound images obtained |
|
| I enjoyed the ultrasound experience today |
|