Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT07676474

Conditions

Pregnant Woman With Single Pregnancy

Ultrasound Fetal Medicine

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wireless Ultrasound Device

Study Details

Brief 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. 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.

Conditions

Pregnant Woman With Single Pregnancy

Ultrasound Fetal Medicine

Study ID

NCT07676474

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Successful continuous abdominal imaging over a defined monitoring interval [ Time Frame: 10-30 minutes ]
  • Number of skin adverse events [ Time Frame: 30 - 60 minutes ]

Central Contacts and Locations

Central contacts

Fetal Imaging Research Team

(617) 919-5088FetalImaging@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Fetal Imaging Research Team

(617) 919-5088FetalImaging@childrens.harvard.edu

Principal Investigator:

Ellen Grant, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Ultrasound
  • Fetal Ultrasound
  • Investigational Device
  • Pregnancy
  • Singleton
  • Single pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.