Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID06861309

Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction

Led by Carilion Clinic ยท Updated on 2026-05-22

60

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

C

Carilion Clinic

Lead Sponsor

V

Virginia Polytechnic Institute and State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two advanced ultrasound technologies, quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), to assess placental health and blood flow in pregnancies with and without fetal growth restriction (FGR). This proof-of-concept, case-control clinical trial aims to determine whether these imaging methods can distinguish healthy pregnancies from those affected by FGR, a condition where the fetus weighs below the 10th percentile for its gestational age. Secondary goals include tracking changes in these ultrasound measures over time and their association with pregnancy complications such as severe FGR, abnormal umbilical artery Doppler results, preeclampsia, preterm birth, and stillbirth. Participants diagnosed with either normal fetal growth or FGR through standard ultrasounds will receive research ultrasounds using the Verasonics Vantage 256 system every three weeks from the time of their routine growth ultrasound until delivery. Each ultrasound session includes a standard exam to confirm fetal viability and anatomical survey, followed by detailed imaging of the placenta at multiple locations using QUS and uPDI. The study ultrasound machine displays safety indicators to ensure exposure stays within guidelines. These research ultrasounds are performed in a calm clinical setting by trained sonographers, with results shared with participants and their healthcare providers. During the study, participants will undergo repeated ultrasound assessments every three weeks until delivery, with data collected on fetal growth, placental blood flow, and tissue characteristics. Researchers will analyze the number and velocity of spiral arteries detected, speed of sound through placental tissue, and other imaging measures to identify differences between healthy and FGR pregnancies. Additional outcomes include rates of abnormal umbilical artery Doppler measurements, preeclampsia, and stillbirth. Participants will also provide demographic and medical history information to help interpret imaging results, and their routine clinical care continues independently of the research.

CONDITIONS

Brief Title

Placental Imaging Techniques

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 45 years at screening
  • Singleton pregnancy without genetic disorders or growth abnormalities
  • Low-risk aneuploidy screening if performed
  • Intention to deliver at Carilion Roanoke Memorial Hospital or Carilion New River Valley Medical Center
  • Anatomical ultrasound survey has been performed
  • For FGR arm: pregnancy diagnosed with fetal growth restriction by estimated fetal weight or abdominal circumference below 10th percentile
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Multiple gestations (twins or more)
  • Known fetal anomaly affecting measurements
  • Suspected fetal genetic disorders
  • Suspected fetal infections
  • Non-English or Spanish speaking
  • Unstable housing or transportation
  • Any other condition making the participant unsuitable for study in the investigator's opinion

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Implementation

Duration - From enrollment until delivery (variable)

Participants have placental ultrasounds performed using an investigational research ultrasound device every three weeks until delivery to evaluate placental health and fetal growth.

Ultrasound visits every 3 weeks until delivery

Trial Site Locations

Total: 1 location

1

Carilion Clinic Maternal Fetal Medicine

Roanoke, Virginia, United States, 24013

Actively Recruiting

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Research Team

M

Megan D Whitham, MD

N

Nicholas Joseph, CCRC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

Comparison of the Hadlock and INTERGROWTH formulasย for calculating estimated fetal weight inย aย preterm population in France.

Isabelle Monier, Anne Ego, Alexandra Benachi...

https://pubmed.ncbi.nlm.nih.gov/30118693

A Comparison of Methods for the Diagnosis of Fetal Growth Restriction Between the Royal College of Obstetricians and Gynaecologists and the American College of Obstetricians and Gynecologists.

Nathan R Blue, Meghan E Beddow, Mariam Savabi...

https://pubmed.ncbi.nlm.nih.gov/29630011