💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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