Pregnant Woman With Single PregnancyNCT07676474
Continuous Wireless Ultrasound to Monitor Fetal Health
An observational study of Pregnant Woman With Single Pregnancy and Ultrasound Fetal Medicine, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Woman With Single Pregnancy, Ultrasound Fetal Medicine
- What is being tested?
- Wireless Ultrasound Device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Pregnant individual 18 years or older
- Singleton uterine pregnancy
- Gestational age 20 to 39 gestational weeks
- Able to provide written informed consent
- Willing to go an single visit lasting 45 minutes - 1 hour including device placement, monitoring and removal
- Willing to permit placement of the wireless bioadhesive ultrasound device on their abdomen for approximately 10-30 minutes
Who cannot join
- 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
- BMI > 35, as the signal quality could be impacted by BMI and not the device specifically
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Fetal Imaging Research Team, (617) 919-5088, FetalImaging@childrens.harvard.edu
Ellen Grant, MD
About this study
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.
- Being tested
- Wireless Ultrasound Device
- Keywords
- Ultrasound, Fetal Ultrasound, Investigational Device, Pregnancy, Singleton, Single pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless Ultrasound DeviceDevice
Also called wireless bioadhesive ultrasound (ABAUS).
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Wireless Ultrasound Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful continuous abdominal imaging over a defined monitoring interval
Acquisition of fetal ultrasound imaging data over a 10-30 minute period
Measured: 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.
Measured: 30 - 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Sep 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Woman With Single PregnancyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Ellen Grant, Boston Children's Hospital
- Investigators
- Ellen Grant, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676474
- Sponsor's protocol ID
- IRB-P00054387
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Wireless Ultrasound to Monitor Fetal Health
- ClinicalTrials.gov ID
- NCT07676474
- Acronym / sponsor ID
- IRB-P00054387
- Keywords
- Ultrasound, Fetal Ultrasound, Investigational Device, Pregnancy, Singleton, Single pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singleton Pregnancy | – | Device: Wireless Ultrasound DeviceHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Pregnant individual 18 years or older
- Singleton uterine pregnancy
- Gestational age 20 to 39 gestational weeks
- Able to provide written informed consent
- Willing to go an single visit lasting 45 minutes - 1 hour including device placement, monitoring and removal
Key exclusion criteria (5 listed)
- 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
- BMI > 35, as the signal quality could be impacted by BMI and not the device specifically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wireless Ultrasound DeviceAlso: wireless bioadhesive ultrasound (ABAUS).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. | Device | Singleton Pregnancy |
Primary outcome
Successful continuous abdominal imaging over a defined monitoring interval
Time frame: 10-30 minutes
Acquisition of fetal ultrasound imaging data over a 10-30 minute period
Number of skin adverse events
Time frame: 30 - 60 minutes
The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen Grant, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Woman With Single Pregnancy and Ultrasound Fetal Medicine, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fetal Imaging Research Team ((617) 919-5088, FetalImaging@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful continuous abdominal imaging over a defined monitoring interval (time frame: 10-30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.