Recruiting

Placental Imaging

Sponsor:

Carilion Clinic

Code:

NCT06861309

Conditions

Fetal Growth Restriction (FGR)

Placental Insufficiency

Preeclampsia

Still Births

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Fetal Growth Restriction (FGR)

Placental Insufficiency

Preeclampsia

Still Births

Pregnancy

Study ID

NCT06861309

Start date

Apr 23, 2025

Status verified date

May, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Normal-Fetal-Weight Pregnancies Arm: Patient at least 18 to 45 years of age at screening
  • Normal-Fetal-Weight Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders or growth abnormalities
  • Normal-Fetal-Weight Pregnancies Arm: Low-risk aneuploidy screening, if performed
  • Normal-Fetal-Weight Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)
  • Normal-Fetal-Weight Pregnancies Arm: Anatomical survey has been performed
  • Normal-Fetal-Weight Pregnancies Arm: Pregnancy without current fetal growth restriction (FGR) diagnosis
  • Normal-Fetal-Weight Pregnancies Arm: Subject willing and able to provide informed consent Note: Verify that the most recent version of the ICF was used to consent the subject
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Patient at least 18 to 45 years of age at screening
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Low-risk aneuploidy screening, if performed
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Anatomical survey has been performed
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Pregnancy diagnosed with fetal growth restriction (FGR) by estimated fetal weight <10th centile or abdominal circumference measurements <10th centile
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Subject willing and able to provide informed consent Note: Verify that the most recent version of the ICF was used to consent the subject

Exclusion Criteria:

  • Normal-Fetal-Weight Pregnancies Arm: Multiple gestations
  • Normal-Fetal-Weight Pregnancies Arm: Known fetal anomaly affecting biometric measurements
  • Normal-Fetal-Weight Pregnancies Arm: Suspected fetal genetic disorder(s)
  • Normal-Fetal-Weight Pregnancies Arm: Suspected fetal infection(s)
  • Normal-Fetal-Weight Pregnancies Arm: Non-English or Spanish-speaking
  • Normal-Fetal-Weight Pregnancies Arm: Unstable housing or transportation
  • Normal-Fetal-Weight Pregnancies Arm: Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment.
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Multiple gestations
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Known fetal anomaly affecting biometric measurements
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal genetic disorder(s)
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal infection(s)
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-English or Spanish-speaking
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Unstable housing or transportation
  • Fetal-Growth-Restricted (FGR) Pregnancies Arm: Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

ultrafast 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.

Primary outcome measure

  • Number of spiral arteries detected by ultrasound [ Time Frame: 40 weeks ]
  • Velocity of spiral artery jets detected by ultrasound [ Time Frame: 40 weeks ]
  • Speed of sound detected by Quantitative Ultrasound [ Time Frame: 40 weeks ]

Central Contacts and Locations

Central contacts

Megan D Whitham, MD

540-985-9985mdwhitham@carilionclinic.org

Nicholas Joseph, CCRC

540-985-8000ncjoseph@carilionclinic.org

Locations

Carilion Clinic Maternal Fetal Medicine

Recruiting

Roanoke, Virginia, United States, 24013

Contacts

Allison R Durica, MD

540-985-9985ardurica@carilionclinic.org

Megan D Whitham, MD

540-985-9985mdwhitham@carilionclinic.org

Principal Investigator:

Megan D Whitham, MD

More Information

Sponsor

Carilion Clinic

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Fetal Growth Restriction
  • FGR
  • Placental Imaging
  • Utero-Placental Insufficiency
  • Growth Restriction
  • Ultrasound
  • Pregnancy
  • Pregnancy Complications
  • Maternal Fetal Medicine
  • Ultrafast Power Doppler Imaging
  • Quantitative Ultrasound
  • uPDI
  • QUS
  • MFM
  • Stillbirth
  • Preeclampsia
  • Verasonics
  • Verasonics Vantage 256
  • Carilion Clinic
  • Virginia Tech

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2026-05-22.