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Search / Trial NCT06861309

Placental Imaging Techniques

Launched by CARILION CLINIC · Mar 4, 2025

Trial Information

Current as of June 14, 2025

Recruiting

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 U Pdi Qus Mfm Stillbirth Preeclampsia Verasonics Verasonics Vantage 256 Carilion Clinic Virginia Tech

ClinConnect Summary

This clinical trial, titled "Placental Imaging Techniques," is exploring how two advanced ultrasound technologies, called quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), can help us better understand the health of the placenta during pregnancy. The study aims to find out if these new imaging methods can effectively tell the difference between healthy pregnancies and those affected by fetal growth restriction (FGR), a condition where a baby is smaller than expected for its gestational age. Researchers will also look at how these imaging techniques can track changes over the course of pregnancy, especially in cases of placental issues like preeclampsia or stillbirth.

Women who are between 18 and 45 years old and are expecting a single baby may be eligible to participate if their pregnancy is classified as normal or if they have been diagnosed with FGR. Participants will receive regular ultrasound scans every three weeks using a special ultrasound machine until they deliver their baby. This study will help gather important information that could improve how we monitor pregnancies and address potential complications. If you are interested in learning more or think you might qualify, please consult with your healthcare provider for further details.

Gender

FEMALE

Eligibility criteria

  • 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: 18 - 26 weeks gestational age without concern for fetal growth restriction (FGR) in the mid-trimester
  • * Normal-Fetal-Weight Pregnancies Arm: No substantial risk factors for FGR:
  • 1. Prior small-for-gestational age child
  • 2. Prior FGR pregnancy
  • 3. Prior preeclampsia
  • 4. Prior gestational hypertension (HTN)
  • 5. Current hypertension (HTN)
  • 6. Current smoking or nicotine use
  • 7. Current cocaine use
  • 8. Current In-vitro fertilization (IVF) pregnancy
  • 9. Current known vascular disease
  • 10. Pre-existing diagnosis of lupus
  • 11. Pre-existing diagnosis of diabetes mellitus \[type I, II\]
  • 12. Pre-existing diagnosis of severe anemia (Hb ≥ 7.9 g/dL)
  • 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.

About Carilion Clinic

Carilion Clinic is a comprehensive healthcare organization based in Virginia, dedicated to providing exceptional patient care, advancing medical research, and enhancing community health. As a leading clinical trial sponsor, Carilion Clinic leverages its extensive network of healthcare professionals and cutting-edge facilities to conduct innovative research across a variety of therapeutic areas. Committed to improving patient outcomes, Carilion Clinic collaborates with academic institutions and industry partners to facilitate clinical trials that adhere to the highest ethical standards and regulatory guidelines, ultimately contributing to the advancement of medical science and the discovery of new treatment options.

Locations

Roanoke, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Megan D Whitham, MD

Principal Investigator

Carilion Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported