Pannus Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study
Public ClinicalTrials.gov record NCT05527327. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05527327
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 15, 2022
- Primary completion
- Oct 16, 2022
- Completion
- Oct 16, 2022
- Last update posted
- Jan 31, 2023
2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29605 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05527327, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05527327 live on ClinicalTrials.gov.