Characterization of Fetal Lung With Quantitative Ultrasound

NCT06722365 | Recruiting

• 3 other identifiers: 2024-0634Protocol Version 3/4/25A532860
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetal Lung Imaging; Respiratory Complication

Outcome Measures

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.

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

Secondary Outcomes (1)

• Population Variance in Fetal Lung Microstructure

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

Study Arms (1)

36 Weeks Pregnant

Device: Backscatter Quantitative Ultrasound

Interventions

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.

Also known as: Ultrasound, bQUS

36 Weeks Pregnant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Meriter Hospital

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• J. Igor Iruretagoyena, MD, MS

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UW Ob/Gyn Human Subjects Core

CONTACT

608-890-3345; research.crc_obgyn@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Coded data and the linking files will be stored for 7 years after conclusion of the study. After seven years, linking files and codes will be destroyed, and the de-identified data will be stored indefinitely for potential future research use.
• Access Criteria: Permission to access data will be provided within Data Sharing Agreements and only after IRB approval.

Locations

US (1)