Evaluating new ultrasound techniques for assessing placental health
Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction
This study is testing new ultrasound techniques to see if they can help tell the difference between healthy pregnancies and those with fetal growth issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Carilion Clinic Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT06861309 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals aged 18 to 45 with singleton gestations between 18 to 26 weeks, who are at low risk for fetal growth restriction.
Not a fit: Patients with known risk factors for fetal growth restriction or those with multiple gestations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of placental issues, potentially reducing risks associated with fetal growth restriction.
How similar studies have performed: While the use of ultrasound techniques for placental assessment is established, the specific combination of QUS and uPDI in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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: 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 this trial is running
Roanoke, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.