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Placental Imaging Techniques

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 22, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Phase changed: not specified → not applicablev3
  2. Minor Primary completion date: Feb 2026 to Jul 2026
    • Study completion date: Feb 2026 to Nov 2026
    • Start date changed from estimate of Mar 2025 to Apr 23, 2025
    • Eligibility criteria shortened, about 82 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06861309
Lead Sponsor Carilion Clinic
Collaborators: Virginia Polytechnic Institute and State University
Conditions
(from sponsor)
Fetal Growth Restriction (FGR), Placental Insufficiency, Preeclampsia, Still Births, Pregnancy, Pregnancy Complications, Pregnancy Outcomes, Ultrasound
Related terms Fetal Growth Retardation, Placental Insufficiency, Pre-Eclampsia, Pregnancy Complications, Stillbirth
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov