Placental Imaging Techniques

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorCarilion Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • ultrafast power Doppler imaging (uPDI) / quantitative ultrasound (QUS)

    Device

    All study participants, regardless of arm, will receive a combine ultrafast power Doppler imaging (uPDI) / quantitative ultrasound (QUS) research exam with the Verasonics Vantage 256 (Verasonics, Inc, Kirkland, WA) every three weeks from their routine growth ultrasound until delivery.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Fetal-Growth-Restricted (FGR) PregnanciesExperimental treatment 1 intervention
Group B: Normal-Fetal-Weight PregnanciesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of spiral arteries detected by ultrasound

Time frame
40 weeks
2

Velocity of spiral artery jets detected by ultrasound

Time frame
40 weeks
3

Speed of sound detected by Quantitative Ultrasound

Time frame
40 weeks

Secondary outcomes

1

Number of Participants with Abnormal Umbilical Artery Doppler Measurement

Time frame
40 week
2

Rate of Preeclampsia in Participants

Time frame
40 week
3

Rate of Stillbirth in Participants

Time frame
40 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carilion Clinic

Lead sponsor

Virginia Polytechnic Institute and State University

Collaborator