Placental Imaging Techniques

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Carilion Clinic
Study ID
NCT06861309
Status
Recruiting
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Conditions

  • Fetal Growth Restriction (FGR)
  • Placental Insufficiency
  • Preeclampsia
  • Pregnancy
  • Pregnancy Complications
  • Pregnancy Outcomes
  • Still Births
  • Ultrasound

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • ultrafast power Doppler imaging (uPDI) / quantitative ultrasound (QUS) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 23, 2025
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Fetal-Growth-Restricted (FGR) Pregnancies
    Eligible subjects diagnosed by standard-of-care, growth ultrasound with a fetal-growth-restricted (FGR) pregnancy will be assigned to this arm. 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 growth ultrasound until delivery.
  • Experimental: Normal-Fetal-Weight Pregnancies
    Eligible subjects diagnosed by standard-of-care, growth ultrasound with a normal-fetal-weight/healthy pregnancy will be assigned to this arm. 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 growth ultrasound until delivery.

Primary Outcome Measure

Number of spiral arteries detected by ultrasound [ Time Frame: 40 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carilion Clinic Maternal Fetal MedicineRoanokeVirginia24013
Allison R Durica, MD
[email protected]
540-985-9985
Megan D Whitham, MD
[email protected]
540-985-9985
Megan D Whitham, MD (PRINCIPAL_INVESTIGATOR)

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Carilion Clinic Maternal Fetal Medicine· Roanoke, VA

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