Continuous Wireless Ultrasound to Monitor Fetal Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Successful continuous abdominal imaging over a defined monitoring interval
研究概览
简要总结
This study is a single-center, prospective, and non-randomized feasibility study designed to evaluate the practicality, tolerability, and data quality of short-duration continuous fetal monitoring using a wireless bioadhesive ultrasound device. The study involves a single visit per participant and does not include any therapeutic intervention.
Eligible participants will undergo placement of a wireless bioadhesive ultrasound (ABAUS) device on the maternal abdomen for a short-duration monitoring session. The device will acquire continuous or semi-continuous ultrasound data for a total of 10-30 minutes per participant, without altering standard clinical care. The study is observational and is intended to assess the technical feasibility of device placement, the stability of the coupling during routine maternal movement, image quality over time, and the ability to monitor fetal motion, heart rate, and uterine activity using the investigational device under controlled yet realistic clinical conditions.
The study is non-interventional. No diagnostic or therapeutic decisions will be made based on the ultrasound data collected as part of this research protocol, and all standard prenatal care will proceed independently of participation in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant individual 18 years or older
- •Singleton uterine pregnancy
- •Gestational age 20 to 39 gestational weeks
- •Able to provide written informed consent
- •Willing to go an single visit lasting 45 minutes - 1 hour including device placement, monitoring and removal
- •Willing to permit placement of the wireless bioadhesive ultrasound device on their abdomen for approximately 10-30 minutes
排除标准
- •Multiple gestation
- •Maternal abdominal skin condition at the potential site of attachment, such as rash, open wound, etc., preventing placement
- •Known allergy or hypersensitivity to adhesive material or hydrogel products
- •Need for urgent clinical management/triage
- •BMI > 35, as the signal quality could be impacted by BMI and not the device specifically
结局指标
主要结局
Successful continuous abdominal imaging over a defined monitoring interval
时间窗: 10-30 minutes
Acquisition of fetal ultrasound imaging data over a 10-30 minute period
Number of skin adverse events
时间窗: 30 - 60 minutes
The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.
次要结局
未报告次要终点
研究者
Ellen Grant
Director of the Fetal Neonatal Neuroimaging and Developmental Science Center (FNNDSC)
Boston Children's Hospital