Placental Imaging Techniques

NCT06861309 | Recruiting FDA Device

• 1 other identifier: IRB-24-2156
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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; Pregnancy Complications; Pregnancy Outcomes; Ultrasound

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

Outcome Measures

Primary Outcomes (3)

• Number of spiral arteries detected by ultrasound

  40 weeks

• Velocity of spiral artery jets detected by ultrasound

  40 weeks

• Speed of sound detected by Quantitative Ultrasound

  40 weeks

Secondary Outcomes (3)

• Number of Participants with Abnormal Umbilical Artery Doppler Measurement

  40 week

• Rate of Preeclampsia in Participants

  40 week

• Rate of Stillbirth in Participants

  40 week

Study Arms (2)

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.

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

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.

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

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.

Fetal-Growth-Restricted (FGR) Pregnancies; Normal-Fetal-Weight Pregnancies

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnancies affected by FGR and Healthy Pregnancies

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic Maternal Fetal Medicine

Roanoke, Virginia, 24013, United States

RECRUITING

Related Publications (6)

• Slator P, Aughwane R, Cade G, Taylor D, David AL, Lewis R, Jauniaux E, Desjardins A, Salomon LJ, Millischer AE, Tsatsaris V, Rutherford M, Johnstone ED, Melbourne A; participants of the workshop. Placenta Imaging Workshop 2018 report: Multiscale and multimodal approaches. Placenta. 2019 Apr;79:78-82. doi: 10.1016/j.placenta.2018.10.010. Epub 2018 Oct 31.

  PMID: 30396518 BACKGROUND

• Hernandez-Andrade E, Huntley ES, Bartal MF, Soto-Torres EE, Tirosh D, Jaiman S, Johnson A. Doppler evaluation of normal and abnormal placenta. Ultrasound Obstet Gynecol. 2022 Jul;60(1):28-41. doi: 10.1002/uog.24816.

  PMID: 34806234 BACKGROUND

• Monier I, Ego A, Benachi A, Ancel PY, Goffinet F, Zeitlin J. Comparison of the Hadlock and INTERGROWTH formulas for calculating estimated fetal weight in a preterm population in France. Am J Obstet Gynecol. 2018 Nov;219(5):476.e1-476.e12. doi: 10.1016/j.ajog.2018.08.012. Epub 2018 Aug 14.

  PMID: 30118693 BACKGROUND

• Blue NR, Beddow ME, Savabi M, Katukuri VR, Mozurkewich EL, Chao CR. 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. Obstet Gynecol. 2018 May;131(5):835-841. doi: 10.1097/AOG.0000000000002564.

  PMID: 29630011 BACKGROUND

• Huang L, Wang Y, Wang R, Wei X, He Q, Zheng C, Peng H, Luo J. High-Quality Ultrafast Power Doppler Imaging Based on Spatial Angular Coherence Factor. IEEE Trans Ultrason Ferroelectr Freq Control. 2023 May;70(5):378-392. doi: 10.1109/TUFFC.2023.3253257. Epub 2023 Apr 26.

  PMID: 37028058 BACKGROUND

• Deeba F, Ma M, Pesteie M, Terry J, Pugash D, Hutcheon JA, Mayer C, Salcudean S, Rohling R. Attenuation Coefficient Estimation of Normal Placentas. Ultrasound Med Biol. 2019 May;45(5):1081-1093. doi: 10.1016/j.ultrasmedbio.2018.10.015. Epub 2019 Jan 23.

  PMID: 30685076 BACKGROUND

Related Links

• Verasonics Vantage 256 System
• Carilion Clinic Maternal Fetal Medicine
• The American College of Obstetrics and Gynecology - Ultrasound Exam FAQ for Patients
• ACOG Guidelines for Diagnostic Imaging During Pregnancy and Lactation

MeSH Terms

Conditions

Fetal Growth Retardation; Placental Insufficiency; Pre-Eclampsia; Pregnancy Complications; Stillbirth

Condition Hierarchy (Ancestors)

Fetal Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Placenta Diseases; Hypertension, Pregnancy-Induced; Fetal Death; Death

Study Officials

• Megan D Whitham, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan D Whitham, MD

CONTACT

540-985-9985; mdwhitham@carilionclinic.org

Nicholas Joseph, CCRC

CONTACT

540-985-8000; ncjoseph@carilionclinic.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 6, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)