Wireless ultrasound monitor for fetal health in a single pregnancy
Official title: Continuous Wireless Ultrasound to Monitor Fetal Health
Run by Boston Children's Hospital · NCT07676474 · Data updated 2026-11-12
A single-center study will test a wireless adhesive ultrasound device on pregnant people with a singleton pregnancy to see if it can be worn comfortably and reliably for 10–30 minutes while collecting fetal and uterine data.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2029 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07676474 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals aged 18 or older with a singleton pregnancy between 20 and 39 weeks gestation who are willing to participate in one visit and have no contraindications to abdominal device placement.
✕Probably not a fit
Patients with multiple gestations, skin conditions at the attachment site, adhesive allergies, urgent clinical needs, or BMI over 35 may not benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-randomized feasibility study conducted at one center to assess the practicality of placing a wireless bioadhesive ultrasound device on the abdomen during pregnancy. It will evaluate how well the device remains attached during movement, the quality of the ultrasound data over time, and the device’s ability to monitor fetal motion, heart rate, and uterine activity without changing standard care. Participants undergo a single 45-minute to 1-hour visit for device placement, monitoring, and removal. The study aims to determine technical feasibility and data reliability of short-duration continuous fetal monitoring with the investigational device. No therapeutic intervention is involved.
Why it matters
Potential benefit: If successful, the device could enable easier, noninvasive continuous fetal monitoring in real-world settings.
How similar studies have gone: Prior work in wearable or wireless fetal monitoring has shown feasibility in data collection, though this specific adhesive ultrasound approach is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Ellen Grant, MD — Boston Children's Hospital
- Study coordinator: Fetal Imaging Research Team
- Email: FetalImaging@childrens.harvard.edu
- Phone: (617) 919-5088
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.