CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
traxi® Panniculus Retractordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05527327
NCT05527327N/ACompleted

Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study

Prisma Health-Upstate·interventional·Posted Sep 2, 2022·Updated Feb 1, 2023

In Brief

A clinical study evaluating traxi® Panniculus Retractor for Obesity and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 2, 2022
Enrollment StartSep 16, 2022
Primary CompletionOct 17, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.8 years ago

Interventions

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.