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NCT05527327 · ClinicalTrials.gov registry record · NA
Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study
A NA study, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT05527327: Completed NA study, sponsored by Prisma Health-Upstate.
NCT05527327 is a NA study that has completed, run by Prisma Health-Upstate. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05527327, a NA study, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DEVICE traxi® Panniculus Retractor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-09-16 |
| Est. Completion | 2022-10-17 |
| Phase | NA |
What the finished NCT05527327 record still lists
NCT05527327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which traxi® Panniculus Retractor is the first listed.
NCT05527327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05527327 about?
NCT05527327 is a clinical study titled "Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot 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 congeni...
What is the current status of trial NCT05527327?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2022-09-16. Estimated completion is 2022-10-17.
What interventions are being tested in trial NCT05527327?
The interventions under investigation include: traxi® Panniculus Retractor (DEVICE).
Who is sponsoring clinical trial NCT05527327?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05527327's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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