Placental Imaging Techniques
Recruiting · NCT06861309 · Interventional (participants receive a specific treatment) · Lead sponsor: Carilion Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Carilion Clinic Maternal Fetal Medicine - Roanoke, Virginia, United States