RECRUITING

Placental Imaging Techniques

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction

Quick Facts

Study Start:2025-03
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06861309

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Normal-Fetal-Weight Pregnancies Arm: Patient at least 18 to 45 years of age at screening
  2. * Normal-Fetal-Weight Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders or growth abnormalities
  3. * Normal-Fetal-Weight Pregnancies Arm: Low-risk aneuploidy screening, if performed
  4. * Normal-Fetal-Weight Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)
  5. * Normal-Fetal-Weight Pregnancies Arm: Anatomical survey has been performed
  6. * Normal-Fetal-Weight Pregnancies Arm: 18 - 26 weeks gestational age without concern for fetal growth restriction (FGR) in the mid-trimester
  7. * Normal-Fetal-Weight Pregnancies Arm: No substantial risk factors for FGR:
  8. 1. Prior small-for-gestational age child
  9. 2. Prior FGR pregnancy
  10. 3. Prior preeclampsia
  11. 4. Prior gestational hypertension (HTN)
  12. 5. Current hypertension (HTN)
  13. 6. Current smoking or nicotine use
  14. 7. Current cocaine use
  15. 8. Current In-vitro fertilization (IVF) pregnancy
  16. 9. Current known vascular disease
  17. 10. Pre-existing diagnosis of lupus
  18. 11. Pre-existing diagnosis of diabetes mellitus \[type I, II\]
  19. 12. Pre-existing diagnosis of severe anemia (Hb ≥ 7.9 g/dL)
  20. * Normal-Fetal-Weight Pregnancies Arm: Pregnancy without current fetal growth restriction (FGR) diagnosis
  21. * 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
  22. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Patient at least 18 to 45 years of age at screening
  23. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-anomalous, singleton gestation without suspected genetic disorders
  24. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Low-risk aneuploidy screening, if performed
  25. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Intention to deliver at Carilion Roanoke Memorial Hospital (CRMH) or Carilion New River Valley Medical Center (CNRVMC)
  26. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Anatomical survey has been performed
  27. * 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
  28. * 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
  1. * Normal-Fetal-Weight Pregnancies Arm: Multiple gestations
  2. * Normal-Fetal-Weight Pregnancies Arm: Known fetal anomaly affecting biometric measurements
  3. * Normal-Fetal-Weight Pregnancies Arm: Suspected fetal genetic disorder(s)
  4. * Normal-Fetal-Weight Pregnancies Arm: Suspected fetal infection(s)
  5. * Normal-Fetal-Weight Pregnancies Arm: Non-English or Spanish-speaking
  6. * Normal-Fetal-Weight Pregnancies Arm: Unstable housing or transportation
  7. * Normal-Fetal-Weight Pregnancies Arm: Any other criterion which, in the clinical judgement of the investigator, would make the subject unsuitable for study enrollment.
  8. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Multiple gestations
  9. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Known fetal anomaly affecting biometric measurements
  10. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal genetic disorder(s)
  11. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Suspected fetal infection(s)
  12. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Non-English or Spanish-speaking
  13. * Fetal-Growth-Restricted (FGR) Pregnancies Arm: Unstable housing or transportation
  14. * 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.

Contacts and Locations

Study Contact

Megan D Whitham, MD
CONTACT
540-985-9985
mdwhitham@carilionclinic.org
Nicholas Joseph, CCRC
CONTACT
540-985-8000
ncjoseph@carilionclinic.org

Principal Investigator

Megan D Whitham, MD
PRINCIPAL_INVESTIGATOR
Carilion Clinic

Study Locations (Sites)

Carilion Clinic Maternal Fetal Medicine
Roanoke, Virginia, 24013
United States

Collaborators and Investigators

Sponsor: Carilion Clinic

  • Megan D Whitham, MD, PRINCIPAL_INVESTIGATOR, Carilion Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-03
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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