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New treatment option for Fetal Growth Restriction (FGR)
Official title Placental Imaging Techniques
ClinicalTrials.gov ID: NCT06861309
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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...
- Normal-Fetal-Weight Pregnancies Arm: Anatomical survey has been performed
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Roanoke, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roanoke, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.