Actively Recruiting
Ultrasound Hemodynamic Assessment in Newly Diagnosed Fetal Growth Restriction: A Pilot Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-02-10
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an ultrasound measurement system called USCOM for patients with newly diagnosed fetal growth restriction (FGR). This observational study aims to understand how well the heart pumps blood during pregnancy when FGR is diagnosed after 27 weeks and 6 days of gestation. The study is sponsored by the Icahn School of Medicine at Mount Sinai and focuses on heart function in relation to pregnancy complications. Participants with a new diagnosis of fetal growth restriction will be monitored using the USCOM device, which measures the amount of blood pumped in and out of the heart. This measurement will be taken every 2 to 4 weeks during routine prenatal ultrasounds until the pregnancy ends. The study observes changes in systemic vascular resistance as the main outcome. Throughout the study, participants will undergo regular prenatal ultrasounds with USCOM assessments to track heart function and blood flow. Researchers will collect data on systemic vascular resistance at these intervals. The study continues until delivery, with no additional treatment given, focusing on observation and monitoring. Total participation time varies depending on when the diagnosis occurs during pregnancy.
CONDITIONS
Brief Title
USCOM in Newly Diagnosed FGR Cases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant patients with a new diagnosis of fetal growth restriction (estimated fetal weight <10th percentile or abdominal circumference <10th percentile) in the third trimester (gestational age >27w6d)
You will not qualify if you...
- Multiple gestation
- Fetal anomalies
- Gestational diabetes or pregestational diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From diagnosis until the end of pregnancy
Participants undergo ultrasound hemodynamic assessments using the USCOM device to measure blood flow in the heart.
Visits every 2 to 4 weeks at the time of prenatal ultrasound
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
N
Nicola F Tavella, MPH
A
Allison Perelman, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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