Recruiting

Fetal Lung

Sponsor:

University of Wisconsin, Madison

Code:

NCT06722365

Conditions

Respiratory Complication

Fetal Lung Imaging

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Backscatter Quantitative Ultrasound

Study Details

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

Respiratory Complication

Fetal Lung Imaging

Study ID

NCT06722365

Start date

Dec 17, 2024

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Arms

36 Weeks Pregnant

Interventions

Backscatter Quantitative Ultrasound

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

UW Ob/Gyn Human Subjects Core

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

Locations

Meriter Hospital

Recruiting

Madison, Wisconsin, United States, 53715

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-25.