Continuous Wireless Ultrasound to Monitor Fetal Health

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBoston Children's Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Singleton Pregnancy1 intervention

Trial outcomes

Primary outcomes

1

Successful continuous abdominal imaging over a defined monitoring interval

Acquisition of fetal ultrasound imaging data over a 10-30 minute period

Time frame
10-30 minutes
2

Number of skin adverse events

The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.

Time frame
30 - 60 minutes

Secondary outcomes

Other outcomes

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: