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NCT Number: NCT06722365

Characterization of Fetal Lung With Quantitative Ultrasound

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Meriter Hospital

Madison, Wisconsin, 53715, United States

Location status: Recruiting

About this study

Primary Objective:

  • Demonstrate the feasibility of performing bQUS analysis on ultrasound echo signals acquired of the fetal lung acquired with clinical ultrasound scanners during third -trimester ultrasound scans

Secondary Objectives:

  • Design and implement a protocol to acquire non-processed (raw) echo signals from a commercial ultrasound scanner necessary to perform bQUS at the UPH-Meriter Center for Perinatal Care (CPC).
  • Quantify the populational variance of quantitative features extracted from bQUS applied to ultrasound data collected from third trimester ultrasound scans of the fetal lung.

The study will be divided into two phases: (i) feasibility phase and (2) hypothesis-testing phase recruitment phase. Phase 1 will provide evidence of the technical viability of data acquisition at 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Subjects unable to consent
  • Active Labor
  • Fetal malformations of the lungs
  • Prescription of corticosteroids prior to ultrasound evaluation
  • Pre-gestation or gestational diabetes mellitus
  • Low English proficiency, needing an interpreter

Treatment and study plan

Backscatter Quantitative Ultrasound

Device

The 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.

Other names: Ultrasound, bQUS

Primary outcomes

  1. Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data

    Time frame: data collected over a single study visit (up to 30 minutes)

    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.

Secondary outcomes

  1. Population Variance in Fetal Lung Microstructure

    Time frame: data collected over a single study visit (up to 30 minutes)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

UW Ob/Gyn Human Subjects Core

CONTACT

[email protected]

608-890-3345

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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