Doppler evaluation of normal and abnormal placenta.
E Hernandez-Andrade, E S Huntley, M F Bartal...
https://pubmed.ncbi.nlm.nih.gov/34806234/Actively Recruiting
Led by Carilion Clinic · Updated on 2026-05-22
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
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
Placental Imaging Techniques
M
Megan D Whitham, MD
N
Nicholas Joseph, CCRC
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Carilion Clinic
Lead Sponsor
Virginia Polytechnic Institute and State University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational uPDI + QUS imaging | Current ultrasound‑Doppler pathway |
|---|---|---|
| What it is | A research exam using combined ultrafast power Doppler imaging and quantitative ultrasound (uPDI + QUS) performed every three weeks from routine growth scans until delivery | Conventional fetal biometry and Doppler ultrasound monitoring of growth restriction as outlined in clinical guidelines |
| Primary use | To evaluate and quantify placental vascularity and fetal growth characteristics using advanced imaging | To monitor fetal growth and placental function and detect compromise using established ultrasound and Doppler methods |
| How it is performed | Every three weeks research imaging with the Verasonics Vantage 256 during routine prenatal growth scans | Serial fetal biometry and Doppler assessments at intervals determined by risk and guidelines |
| Evidence status | Under active investigation in this trial; diagnostic value not yet established | Widely validated and recommended for fetal growth surveillance |
| Important limitations | Not yet validated outside research; equipment and processing may not be widely available | Standard Doppler may detect compromise late and has limited sensitivity for early placental dysfunction |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/30685076/Carilion Clinic
Lead Sponsor
Virginia Polytechnic Institute and State University
Collaborating Sponsor