Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

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.

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.