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Placental Imaging Techniques

Evaluation of Innovative Placental Imaging Techniques in Fetal Growth Restriction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "QUS imaging creates a number of values including an attenuation coefficient estimate (ACE), specified in decibels (dB) which is a measurement of the ultrasound waves' absorption and scattering as they move through human tissue."
  • "Researchers will also investigate power Doppler imaging (uPDI), a newer ultrasound modality that uses an ultra-high frame rate and clutter filtering to increase the Doppler imaging sensitivity."
  • "Traditional Doppler ultrasound displays color onto the normally greyscale ultrasound where blood flow is seen by the machine."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two newer types of ultrasound to check the placenta, the organ that supplies the baby with nutrients and oxygen, and its blood flow. It is for people pregnant with one baby, with or without fetal growth restriction (when the baby is smaller than expected). Participants will have research ultrasounds every three weeks after their routine growth scans until delivery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 45 years old at screening.
  • Be pregnant with one baby who has no known birth defects or suspected genetic disorders.
  • If screening for chromosome disorders was done, results must show low risk.
  • Plan to give birth at Carilion Roanoke Memorial Hospital or Carilion New River Valley Medical Center.
  • Have already had an ultrasound that checks the baby's body parts.
  • For the normal-growth group: have no suspected growth problems or current diagnosis of fetal growth restriction.
  • For the restricted-growth group: the baby's estimated weight or belly size must be below that of 90 out of 100 babies at the same stage of pregnancy.
  • Be willing and able to give informed consent, meaning you understand the study and agree to join.

Who can't join

  • Be pregnant with more than one baby.
  • The baby has a known birth defect that affects body measurements.
  • The baby has a suspected genetic disorder.
  • The baby has a suspected infection.
  • Do not speak English or Spanish.
  • Have unstable housing or transportation.
  • The study doctor finds another reason that makes joining the study unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

VA