Diagnostic Ultrasound System: Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.
Study summary
This study collects obstetric ultrasound images from pregnant participants using the UIH uSONIQUE Nova diagnostic ultrasound system (uC7-1s transducer). The goal is to obtain standardized, high-quality images to support artificial intelligence (AI) algorithm development, AI training and validation, and automated obstetric measurement workflows. Results will support a premarket notification (510(k)) submission to the U.S. FDA.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
1. Pregnant persons age 18-45 years
2. Single intrauterine pregnancy
3. Gestational duration: 18 - 28 weeks
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.).
2. Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic intervention.
3. Pregnant individuals with a medical or surgical history that may impact quality of ultrasound imaging:
* Body Mass Index (BMI) \> 40
* Prior surgeries including: abdominal mesh placement; abdominoplasty
* Vaginal bleeding within the last 6 weeks
4. Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma.
5. Use of any of the following during pregnancy: marijuana (or similar derivatives); alcohol; tobacco; methamphetamines; warfarin; isotretinoin; methotrexate; valproic acid; retinoids; oral steroids
6. Non-English speaking.
7. Participants deemed unsuitable by the investigator due to safety or data integrity.
Primary outcome measure(s)
Complete Fetal Biometric Image Set Collection — Day 1 Number of participants from whom complete fetal biometric image sets are successfully collected, including Biparietal Diameter (BPD), Head Circumference (HC), Abdominal Circumference (AC), and Femur Length (FL), in compliance with the study scanning protocol standards
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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