Continuous Wireless Ultrasound to Monitor Fetal Health

Conditions

• Pregnant Woman With Single Pregnancy
• Ultrasound Fetal Medicine

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Wireless Ultrasound Device — DEVICE
  Participants 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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Singleton Pregnancy
  Healthy persons pregnant with a single fetus. All participants will be recruited through Boston Children's Hospital's Fetal Care and Surgery Center and must be receiving a fetal MRI as part of their clinical care.

Primary Outcome Measure

Successful continuous abdominal imaging over a defined monitoring interval [ Time Frame: 10-30 minutes ]

Central Contacts

• Fetal Imaging Research Team
  (617) 919-5088
  [email protected]

Locations (1)

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