Pannus Assistance Needed for Obstetric Ultrasound Studies: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Completion Rate of 16 Prespecified Views
研究概览
简要总结
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?
详细描述
Pregnancies complicated by obesity have an increased risk of multiple pregnancy complications, including structural fetal anomalies. Ultrasound is a critical tool for the detection of congenital anomalies; however, adequate visualization of fetal anatomy by ultrasound decreases as body mass index increases. Placing a pannus retractor adhesive is a simple intervention that redistributes adiposity, providing better access to an important acoustic window for fetal ultrasound.
The investigators will conduct a randomized controlled trial comparing outcomes between groups that undergo fetal anatomy ultrasound examinations with or without use of a pannus retractor adhesive. The adequacy of ultrasound visualization is the primary outcome of interest. Secondary outcomes of interest include sonographer pain perception, participant satisfaction, adequacy of all detailed anatomy views, detection of fetal anomalies, skin to amniotic cavity depth, duration of ultrasound exam, and adverse reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Size of varying blocks used within the permuted block design randomization will be masked to investigators. Efforts will be made to mask the physician who is interpreting the ultrasound from participant allocation; the participant and sonographer will be asked not to disclose the study arm to the interpreting physician, and no ultrasound images that would reveal study group allocation will be saved for the physician's view.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Completion Rate of 16 Prespecified Views
时间窗: through study completion, an average of 1 day per participant
Views including: brain (lateral ventricles, cerebellum, cavum), face, heart (four chamber view, right outflow tract, left outflow tract, three vessel view, three vessel trachea view), spine (cervical, thoracic, lumbar, sacrum, and spine shape will be summarized as one spine view), ventral wall, umbilical cord, stomach, left and right kidneys, and bladder.
次要结局
- Completion Rate of All 64 Views(through study completion, an average of 1 day per participant)
- Duration of Ultrasound Exam(through study completion, an average of 1 day per participant)
- Detection of Major Fetal Anomalies(through study completion, an average of 1 day per participant)
- Depth to Amniotic Cavity(through study completion, an average of 1 day per participant)
- Adverse Effects(through study completion, an average of 1 day per participant)
- Sonographer Survey(through study completion, an average of 1 day per participant)
- Participant Survey(through study completion, an average of 1 day per participant)