ObesityNCT05527327
Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study
A study testing traxi® Panniculus Retractor in people with Obesity and Pregnancy Complications, run by Prisma Health-Upstate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Obesity, Pregnancy Complications, 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2022to 17 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Aim 1: Determine the completion rate of detailed obstetric ultrasound when using the pannus retractor device adhesive for participants with BMI of 40 kg/m2 or greater. 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. We will prospectively enroll twenty participants with BMI of at least 40 kg/m2 who consent to having a pannus retractor device adhesive placed for their anatomic ultrasound exam. Inclusion and exclusion criteria will be followed as detailed elsewhere. Participant measurements including current height, weight, and pannus grade will be recorded. The pannus retractor device adhesive will be placed by research personnel and sonographers who have been trained in proper application of the device, per manufacturer's instructions. The start time of adhesive application will be recorded. The ultrasound exam will then proceed as a routine ultrasound exam, except for two additional ultrasound measurements. Using no pressure, the distance from ultrasound probe to the amniotic cavity will be measured with and without the pannus retractor in place. Other collection variables will be available from chart review, namely age, race, ethnicity, insurance status, estimated due date, pre-pregnancy BMI, BMI at first obstetric visit, diabetic status, smoking status, parity, prior abdominal surgical status, date of ultrasound, fetal presentation, placental location, sonographer, reading physician, time of first and last ultrasound image acquisition, and whether transvaginal imaging was used. The outcome measure of interest, completion of adequate visualization of sixteen views, will be available from review of the final ultrasound report. The rate of completed studies from the prospective population will be compared to historical data to determine if Aim 1 hypothesis is true.
Aim 2: Determine changes to the sonographer experience for the 20 patients enrolled in the prospective cohort portion of this project. A survey will be administered to the sonographers who perform the ultrasounds with the pannus retractor adhesive in use. The amount of discomfort experienced in their arm or shoulder while scanning, their confidence in the quality of their images, and whether the ultrasound was made easier by use of the adhesive will be assessed by a Likert scale with space for free text comments.
Aim 3: Evaluate the participant experience for the 20 patients enrolled in the prospective cohort portion of this project. The comfort, satisfaction and enjoyment of the ultrasound experience will be assessed by a Likert scale.
- Conditions
- Obesity, Pregnancy Complications, Fetal Anomaly, Pannus
- Being tested
- traxi® Panniculus Retractor
- Keywords
- obesity, pregnancy, pannus, ultrasound, fetal anomaly
- Medical subject headings
- Obesity, Pregnancy Complications, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traxi® Panniculus RetractorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective arm | Experimental | All prospective participants will be consented to use of the intervention, a pannus retractor at time of detailed obstetric ultrasound. Receives: Device: traxi® Panniculus Retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one month from each individual's participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start16 Sep 2022
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All prospective participants will receive the intervention for one occurrence. Retrospective participants' results will be observed without any intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Pasko, MD, Principal investigator, Prisma Health Maternal-Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527327
- Sponsor's protocol ID
- 1935904-1
- Status last verified
- Jan 2023
- First submitted
- 31 Aug 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study investigators will have access to the database management system that includes IPD. Only de-identified results will be distributed after analysis.
Publications
Lashen H, Fear K, Sturdee DW. Obesity is associated with increased risk of first trimester and recurrent miscarriage: matched case-control study. Hum Reprod. 2004 Jul;19(7):1644-6. doi: 10.1093/humrep/deh277. Epub 2004 May 13.
PubMed 15142995Stothard 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 22713503AIUM 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 19384114Obesity in Pregnancy: ACOG Practice Bulletin, Number 230. Obstet Gynecol. 2021 Jun 1;137(6):e128-e144. doi: 10.1097/AOG.0000000000004395.
PubMed 34011890Dashe 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.
PubMed 19643785Thornburg 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 19479682Pasko 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 27698181Simmons 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.
PubMed 33277924
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study
- ClinicalTrials.gov ID
- NCT05527327
- Acronym / sponsor ID
- 1935904-1
- Conditions
- Obesity, Pregnancy Complications, Fetal Anomaly, Pannus
- Keywords
- obesity, pregnancy, pannus, ultrasound, fetal anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim 1: Determine the completion rate of detailed obstetric ultrasound when using the pannus retractor device adhesive for participants with BMI of 40 kg/m2 or greater. 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. We will prospectively enroll twenty participants with BMI of at least 40 kg/m2 who consent to having a pannus retractor device adhesive placed for their anatomic ultrasound exam. Inclusion and exclusion criteria will be followed as detailed elsewhere. Participant measurements including current height, weight, and pannus grade will be recorded. The pannus retractor device adhesive will be placed by research personnel and sonographers who have been trained in proper application of the device, per manufacturer's instructions. The start time of adhesive application will be recorded. The ultrasound exam will then proceed as a routine ultrasound exam, except for two additional ultrasound measurements. Using no pressure, the distance from ultrasound probe to the amniotic cavity will be measured with and without the pannus retractor in place. Other collection variables will be available from chart review, namely age, race, ethnicity, insurance status, estimated due date, pre-pregnancy BMI, BMI at first obstetric visit, diabetic status, smoking status, parity, prior abdominal surgical status, date of ultrasound, fetal presentation, placental location, sonographer, reading physician, time of first and last ultrasound image acquisition, and whether transvaginal imaging was used. The outcome measure of interest, completion of adequate visualization of sixteen views, will be available from review of the final ultrasound report. The rate of completed studies from the prospective population will be compared to historical data to determine if Aim 1 hypothesis is true.
Aim 2: Determine changes to the sonographer experience for the 20 patients enrolled in the prospective cohort portion of this project. A survey will be administered to the sonographers who perform the ultrasounds with the pannus retractor adhesive in use. The amount of discomfort experienced in their arm or shoulder while scanning, their confidence in the quality of their images, and whether the ultrasound was made easier by use of the adhesive will be assessed by a Likert scale with space for free text comments.
Aim 3: Evaluate the participant experience for the 20 patients enrolled in the prospective cohort portion of this project. The comfort, satisfaction and enjoyment of the ultrasound experience will be assessed by a Likert scale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All prospective participants will receive the intervention for one occurrence. Retrospective participants' results will be observed without any intervention.
| Arm | Type | Receives |
|---|---|---|
| Prospective arm | Experimental | Device: traxi® Panniculus RetractorAll prospective participants will be consented to use of the intervention, a pannus retractor at time of detailed obstetric ultrasound. |
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)
- 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
Key exclusion criteria (4 listed)
- 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
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 RetractorThis 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. | Device | Prospective arm |
Primary outcome
Complete ultrasound study (yes/no)
Time frame: Up to one month from each individual's participation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 15142995Lashen H, Fear K, Sturdee DW. Obesity is associated with increased risk of first trimester and recurrent miscarriage: matched case-control study. Hum Reprod. 2004 Jul;19(7):1644-6. doi: 10.1093/humrep/deh277. Epub 2004 May 13.
- 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 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 34011890Obesity in Pregnancy: ACOG Practice Bulletin, Number 230. Obstet Gynecol. 2021 Jun 1;137(6):e128-e144. doi: 10.1097/AOG.0000000000004395.
- Background: PubMed 19643785Dashe 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.
- 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.
- 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 33277924Simmons 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.
- Individual participant dataSharing planned: No. All study investigators will have access to the database management system that includes IPD. Only de-identified results will be distributed after analysis.
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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 Maternal-Fetal Medicine
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 and Pregnancy Complications, 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 4 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 1 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete ultrasound study (yes/no) (time frame: Up to one month from each individual's participation). 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 NCT05527327, which also lists 11 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 1 Feb 2023.