Evaluating new ultrasound techniques for assessing placental health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness of two advanced ultrasound technologies, quantitative ultrasound (QUS) and ultrafast power Doppler imaging (uPDI), in evaluating placental health and blood flow in singleton pregnancies. The primary objective is to differentiate between healthy pregnancies and those affected by fetal growth restriction (FGR). Secondary objectives include monitoring changes in ultrasound imaging over the course of pregnancy and identifying potential complications related to placental insufficiency. The study will utilize both experimental and FDA-approved ultrasound machines to gather data.

Why it matters

Who can join: the full rules

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's running

• Carilion Clinic Maternal Fetal Medicine
  Roanoke, Virginia, United States Recruiting

Study contacts

• Principal investigator: Megan D Whitham, MD — Carilion Clinic
• Study coordinator: Megan D Whitham, MD
• Email: mdwhitham@carilionclinic.org
• Phone: 540-985-9985

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.