Obesity Complicating ChildbirthNCT05764408
Pannus Assistance Needed for Obstetric Ultrasound Studies
A study testing traxi® Panniculus Retractor in people with Obesity Complicating Childbirth and Fetal Anomaly, run by Prisma Health-Upstate at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Obesity Complicating Childbirth, Fetal Anomaly
- What is being tested?
- traxi® Panniculus Retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 13 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Obesity Complicating Childbirth, Fetal Anomaly
- Being tested
- traxi® Panniculus Retractor
- Keywords
- Obesity, Fetal ultrasound, Fetal anatomy, Pannus
- Medical subject headings
- Congenital Abnormalities, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traxi® Panniculus RetractorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: traxi® Panniculus Retractor |
| No retractor | No intervention | The detailed anatomic survey will proceed per normal protocol. Approaches may include transabdominal and transvaginal imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 day per participant
Secondary outcomes (7)
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.
Measured: 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
Measured: through study completion, an average of 1 day per participant
Detection of Major Fetal Anomalies
Per EUROCAT guidelines
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: through study completion, an average of 1 day per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start10 Mar 2023
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obesity Complicating ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University
- Responsible party
- Sponsor
- Investigators
- Daniel Pasko, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764408
- Sponsor's protocol ID
- 2012318-1
- Status last verified
- Jul 2024
- First submitted
- 28 Feb 2023
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Obesity in Pregnancy: ACOG Practice Bulletin, Number 230. Obstet Gynecol. 2021 Jun 1;137(6):e128-e144. doi: 10.1097/AOG.0000000000004395.
PubMed 34011890AIUM 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.
PubMed 31736130Weichert 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.
PubMed 21480286Dashe 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.
PubMed 19384114Thornburg 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.
PubMed 19479682Bagley 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.
PubMed 20606587Stothard 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.
PubMed 19211471Racusin 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.
PubMed 22713503Pasko 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.
PubMed 27698181Hendler 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.
PubMed 15303105Wise 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.
PubMed 39053011
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pannus Assistance Needed for Obstetric Ultrasound Studies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05764408
- Acronym / sponsor ID
- 2012318-1
- Conditions
- Obesity Complicating Childbirth, Fetal Anomaly
- Keywords
- Obesity, Fetal ultrasound, Fetal anatomy, Pannus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retractor | Experimental | Device: traxi® Panniculus RetractorResearch 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traxi® Panniculus Retractortraxi® 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. | Device | Retractor |
Primary outcome
Completion Rate of 16 Prespecified Views
Time frame: through study completion, an average of 1 day per participant
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.
7 secondary outcomes
Completion Rate of All 64 Views
Time frame: through study completion, an average of 1 day per participant
Duration of Ultrasound Exam
Time frame: through study completion, an average of 1 day per participant
Detection of Major Fetal Anomalies
Time frame: through study completion, an average of 1 day per participant
Depth to Amniotic Cavity
Time frame: through study completion, an average of 1 day per participant
Adverse Effects
Time frame: through study completion, an average of 1 day per participant
Sonographer Survey
Time frame: through study completion, an average of 1 day per participant
Participant Survey
Time frame: through study completion, an average of 1 day per participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34011890Obesity in Pregnancy: ACOG Practice Bulletin, Number 230. Obstet Gynecol. 2021 Jun 1;137(6):e128-e144. doi: 10.1097/AOG.0000000000004395.
- Background: PubMed 31736130AIUM 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.
- Background: PubMed 21480286Weichert 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.
- Background: PubMed 19384114Dashe 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.
- Background: PubMed 19479682Thornburg 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.
- BackgroundBagley 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: PubMed 20606587Iglesias 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.
- Background: PubMed 19211471Stothard 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.
- Background: PubMed 22713503Racusin 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.
- Background: PubMed 27698181Pasko 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.
- Background: PubMed 15303105Hendler 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.
- Derived from this study: PubMed 39053011Wise 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Pasko, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traxi® Panniculus Retractor in people with Obesity Complicating Childbirth and Fetal Anomaly, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of 16 Prespecified Views (time frame: through study completion, an average of 1 day per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764408, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.