Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction
Carilion Clinic
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.
Description
Background: This study is a proof-of-concept, case-control exploration of quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI) imaging techniques, applied to the placenta to evaluate health of the placenta, blood flow visualized by colored doppler imaging in patients with and without FGR. Investigators will utilize the Verasonics Vantage 256 research ultrasound machine (Verasonics, Inc, Kirkland, WA) for this study, which is not FDA approved/experimental, along with a standard-of-care Phillips ultrasound machine which is FDA approved. Use of QUS gained interest within the…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- Deviceultrafast 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.
Location
- Carilion Clinic Maternal Fetal MedicineRoanoke, Virginia