N/A
N=150
Pannus Assistance Needed for Obstetric Ultrasound Studies
Obesity Complicating Childbirth · Fetal Anomaly
Bottom Line
View on ClinicalTrials.gov: NCT05764408 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
Nov 2024
Primary outcome: Primary: Completion Rate of 16 Prespecified Views — 19; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- traxi® Panniculus Retractor (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Prisma Health-Upstate
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate of 16 Prespecified Views |
19; 24 | — |
| SECONDARY Completion Rate of All 64 Views |
10; 12 | — |
| SECONDARY Duration of Ultrasound Exam |
34.9; 33.7 | 0.47 |
| SECONDARY Detection of Major Fetal Anomalies |
0; 0 | — |
| SECONDARY Depth to Amniotic Cavity |
5.0; 5.0 | 0.81 |
| SECONDARY Adverse Effects |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Sonographer Survey |
3.7; 3.9; 4.1; 4.3; 3.8; 3.6 | — |
| SECONDARY Participant Survey |
4.6; 4.8; 4.6; 4.5; 4.6; 4.7 | — |
Summary
The goal of this randomized controlled trial is to evaluate whether use of a pannus retractor adhesive improves fetal anatomic ultrasound examinations. The primary question it aims to answer is:
• Does the use of a pannus retractor adhesive increase the rate of detailed anatomic survey completion, defined by satisfactory visualization of sixteen prespecified fetal anatomy views, for participants with a pannus and body mass index of at least 40 kg/m2?
Eligibility Criteria
Inclusion Criteria
- English or Spanish speaking
- BMI of at least 40.0 kg/2, calculated within 6 months of conception or at the first obstetric visit
- Pannus grade 1 or greater
- Gestational age between 18 weeks 0 days to 23 weeks 6 days, confirmed by prior ultrasound assessment
Exclusion Criteria
- Patients who have already had a routinely timed anatomy ultrasound during the same pregnancy with Prisma Health Maternal-Fetal Medicine
- Patients with a known major fetal anomaly, confirmed by Prisma Health Maternal-Fetal Medicine
- Tape/adhesive allergy
- Multifetal gestation
- Intrauterine fetal demise
Data sourced from ClinicalTrials.gov (NCT05764408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.