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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 is a NA study that has completed, run by Prisma Health-Upstate. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05527327
The ClinicalTrials.gov registry entry for NCT05527327 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prisma Health-Upstate, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which traxi® Panniculus Retractor is the first listed.
NCT05527327 reports 0 study locations.
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.
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