Pregnant Woman With Single Pregnancy, Ultrasound Fetal Medicine
Conditions
Keywords
Ultrasound, Fetal Ultrasound, Investigational Device, Pregnancy, Singleton, Single pregnancy
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.
Interventions
DEVICEWireless 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.
Sponsors
Boston Children's Hospital
Massachusetts Institute of Technology
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful continuous abdominal imaging over a defined monitoring interval | 10-30 minutes | Acquisition of fetal ultrasound imaging data over a 10-30 minute period |
| Number of skin adverse events | 30 - 60 minutes | The number of participants experiencing adverse effects, discomfort, or skin irritation related to the device will be recorded. |
Countries
United States
Contacts
CONTACTFetal Imaging Research Team
PRINCIPAL_INVESTIGATOREllen Grant, MD
Boston Children's Hospital
Outcome results
None listed