Characterization of Fetal Lung With Quantitative Ultrasound
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Wisconsin, Madison
About this trial
The purpose of the study is to show if it's possible to use a special kind of ultrasound called backscatter quantitative ultrasound (bQUS) to check on a baby's lungs when the mother is 36 weeks pregnant. 16 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant females ages 18 to 45 years old with singleton pregnancy, live fetus, gestational age between 32.1 and 36.7 weeks, not in labor, scheduled for routine ultrasound growth evaluation.
Gestational age determined by the date of the last menses, and confirmed by measurement of the crown-rump-length on transabdominal ultrasound.
Disqualifiers
Subjects unable to consent
Active Labor
Fetal malformations of the lungs
Prescription of corticosteroids prior to ultrasound evaluation
Trial population
Pregnant females ages 18 to 45 years old with singleton pregnancy, live fetus, gestational age between 32.1 and 36.7 weeks, not in labor, scheduled for routine ultrasound growth evaluation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Backscatter Quantitative Ultrasound
DeviceThe intervention consists of a regular abdominal ultrasound scan for fetal evaluation. The difference with a regular scan is that the scanner used to image the fetus provides access to raw/unprocessed ultrasound echo data that can be extracted from the scanner and processed offline (after acquisition) to extract compute backscatter quantitative ultrasound (bQUS) features. Thus, data acquisition does not represent a significant departure from conventional fetal imaging protocols. Other than the time needed to acquire the images, the participant will not perceive any difference from a regular fetal ultrasound scan.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: 36 Weeks Pregnant1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data
Phase 1 will provide evidence of the technical viability of data acquisition at the UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.
Time frame
data collected over a single study visit (up to 30 minutes)Secondary outcomes
1
Population Variance in Fetal Lung Microstructure
Populational variance σ\^2\_Pop: variance of the individual participant median value of a quantitative ultrasound feature q\_(M,s) obtained from the N\_S participants included in the analysis.
Time frame
data collected over a single study visit (up to 30 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov