NCT06407388

Ultrasound Findings in Diabetic Pregnancies

Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 156 (estimated)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of our study is to identify ultrasonographic markers that can predict adverse neonatal outcomes. Specifically, we hypothesize that an increase in fetal liver volumes will increase transcutaneous bilirubin (TcB) in the newborn and thus jaundice requiring phototherapy. This information can be used in patient counseling and to guide future screening protocols for ultrasound in individuals with diabetes.

Detailed description

This is a single center, prospective case control study. Cases will be collected prospectively and control subjects will be data collected retrospectively from the reference population of the human placenta project (IRB #15-09-FB-0179). If patients agree to participate, one ultrasound will be performed at 30-34 weeks' gestation to look at the fetal parameters as described below. It is standard of care for all patients with pregestational diabetes to receive growth ultrasounds throughout their pregnancy. Patients who are diagnosed with pregestational diabetes at EVMS routinely undergo an ultrasound at 30-34 weeks' gestation. Therefore, ultrasound data will be collected during their scheduled 30-34 week ultrasound visit and no additional ultrasounds will need to be performed. At the time of enrollment, the PI or other study collaborator will ensure that the patient has previously had a detailed ultrasound evaluation (Code 76811). These patients will then be followed prospectively until delivery. The neonates of the study patients will be followed via chart review after delivery.

Conditions

• Diabetes

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-01-01
• Completion: 2025-06-01
• First posted: 2024-05-09
• Last updated: 2024-05-09

Locations

1 site across 1 country: United States