Study of Backscatter Quantitative Ultrasound to Examine Fetal Lungs in Pregnant Women Between 32 and 36 Weeks

What this Trial Is About

Researchers are exploring the use of a specialized ultrasound technique called backscatter quantitative ultrasound bQUS to assess fetal lung development during late pregnancy. This observational study focuses on pregnant females between 18 and 45 years old who have a single, live fetus and are between 32.1 and 36.7 weeks of gestation. The study aims to demonstrate whether bQUS can technically capture useful data during routine third-trimester ultrasound scans and to analyze the variation of lung features across the population. Participants will undergo one ultrasound session lasting up to 30 minutes, where standard abdominal fetal imaging is performed using a scanner capable of capturing raw ultrasound data for offline bQUS analysis. The study has two phases an initial feasibility phase with 5 participants to assess technical viability, followed by a hypothesis-testing phase to recruit up to 16 participants for population analysis if feasible. The ultrasound procedure is similar to routine care, with no perceptible difference for participants besides the time needed for data capture. During the single study visit, researchers will collect non-processed ultrasound echo signals and analyze them to measure fetal lung microstructure. The primary outcome is the number of participants enrolled as a measure of feasibility. Secondary outcomes include the population variance of lung ultrasound features. The study includes monitoring for technical challenges and involves no additional procedures beyond the ultrasound. Total participant involvement is one visit lasting approximately 30 minutes.

Characterization of Fetal Lung With Quantitative Ultrasound