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Continuous Wireless Ultrasound to Monitor Fetal Health

Recruitingn/aAges 18 Years - anyFemaleBoston Children's Hospital
NCT07676474 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, hear

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Pregnant individual 18 years or older 2. Singleton uterine pregnancy 3. Gestational age 20 to 39 gestational weeks 4. Able to provide written informed consent 5. Willing to go an single visit lasting 45 minutes - 1 hour including device placement, monitoring and removal 6. Willing to permit placement of the wireless bioadhesive ultrasound device on their abdomen for approximately 10-30 minutes Exclusion Criteria: 1. Multiple gestation 2. Maternal abdominal skin condition at the potential site of attachment, such as rash, open wound, etc., preventing placement 3. Known allergy or hypersensitivity to adhesive material or hydrogel products 4. Need for urgent clinical management/triage 5. BMI \> 35, as the signal quality could be impacted by BMI and not the device specifically
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What it tests

  • Wireless Ultrasound Device
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Where

1 site
Boston Children's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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