Continuous Wireless Ultrasound to Monitor Fetal Health

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnant Woman With Single Pregnancy; Ultrasound Fetal Medicine
• Intervention / Treatment: Device: Wireless Ultrasound Device

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Fetal Imaging Research Team; Phone Number: (617) 919-5088; Email: FetalImaging@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
      • Principal Investigator: Ellen Grant, MD
      • Contact: Fetal Imaging Research Team; Phone Number: (617) 919-5088; Email: FetalImaging@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Wireless Ultrasound 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.; Other Names: wireless bioadhesive ultrasound (ABAUS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful continuous abdominal imaging over a defined monitoring interval	Acquisition of fetal ultrasound imaging data over a 10-30 minute period	10-30 minutes
Number of skin adverse events	The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.	30 - 60 minutes

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Massachusetts Institute of Technology
• Investigators: Principal Investigator: Ellen Grant, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Pregnancy; Fetal Ultrasound; Singleton; Investigational Device; Single pregnancy
• Other Study ID Numbers: IRB-P00054387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No