RecruitingNCT06861309

Placental Imaging Techniques

Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction


Sponsor

Carilion Clinic

Enrollment

60 participants

Start Date

Apr 23, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this proof-of-concept, case-control, clinical trial is to evaluate the efficacy of using two newer ultrasound technologies, quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), to evaluate the health of the placenta, visualize blood flow through the placental vasculature by color Doppler imaging in singleton pregnancies with and without fetal growth restriction (FGR). * Our primary objective is to investigate the ability of using these ultrasound technologies to distinguish healthy pregnancies from those affected by FGR, a condition characterized by a fetal weight below the 10th percentile for the gestational age or abdominal circumference of the pregnancy. * Secondary aims include longitudinal evaluation of differences in QUS and uPDI imaging over gestation and changes in these measures with evolution of utero-placental insufficiency including with the development of abnormal umbilical-artery Doppler testing, diagnosis of severe FGR, identification of stillbirth, and detection of preeclampsia or preterm birth. Investigators will compare QUS/uPDI imaging and values in pregnancies determined to be healthy by approved, standard-of-care growth ultrasounds to those diagnosed with FGR. Participants will receive research ultrasounds with the experimental Verasonics Vantage 256 system (Verasonics, Inc, Kirkland, WA) utilizing uPDI/QUS every three weeks following their routine growth ultrasound evaluation until delivery. Demographic, obstetric, and delivery-related information, as well as portions of subjects' past medical history will be utilized by researchers to further contextualize imaging and variables gathered during the research ultrasounds.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different imaging techniques to look at the placenta during pregnancy, to better understand how placental health relates to fetal growth — including in pregnancies where the baby is growing normally and in those where growth restriction has been detected. **You may be eligible if...** - You are between 18 and 45 years old and pregnant - You are carrying a single baby without known genetic problems or growth issues (for the normal-weight group) - OR you have been diagnosed with fetal growth restriction (for the growth restriction group) - You plan to deliver at a participating hospital - An anatomy scan has already been completed **You may NOT be eligible if...** - You are carrying twins or a baby with known birth defects - You do not plan to deliver at a participating hospital - You are not able to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEultrafast power Doppler imaging (uPDI) / quantitative ultrasound (QUS)

All study participants, regardless of arm, will receive a combine ultrafast power Doppler imaging (uPDI) / quantitative ultrasound (QUS) research exam with the Verasonics Vantage 256 (Verasonics, Inc, Kirkland, WA) every three weeks from their routine growth ultrasound until delivery.


Locations(1)

Carilion Clinic Maternal Fetal Medicine

Roanoke, Virginia, United States

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NCT06861309


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