About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant individual 18 years or older
Singleton uterine pregnancy
Gestational age 20 to 39 gestational weeks
Able to provide written informed consent
Disqualifiers
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
Trial population
The study population is limited to persons with a single pregnancy who are receiving a clinically-ordered MRI at Boston Children's Hospital as part of their clinical care.
Trial design
Case-only
Prospective
Treatments tested in this trial
Wireless Ultrasound Device
DeviceParticipants will undergo placement of the investigational wireless bio-adhesive ultrasound (ABAUS) device on the maternal abdomen. This device constitutes the sole study-related exposure. The device will be externally applied to intact abdominal skin using a skin-safe bio-adhesive and used to acquire continuous or semi-continuous ultrasound data for approximately 10-30 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Successful continuous abdominal imaging over a defined monitoring interval
Acquisition of fetal ultrasound imaging data over a 10-30 minute period
Number of skin adverse events
The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.
Sponsors and contacts
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Boston Children's Hospital
Lead sponsor
Massachusetts Institute of Technology
Collaborator
This trial is not recruiting at the moment. You can still explore other options: