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NCT06343051 Clinical Trial

USCOM in Newly Diagnosed FGR Cases

Fetal Growth Restriction Clinical Trial

— USCOM FGR  

Official title:
Ultrasound Hemodynamic Assessment in Newly Diagnosed Fetal Growth Restriction: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06343051
Other study ID # STUDY-23-01681
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2026

Study information
Verified date March 2024
Source Icahn School of Medicine at Mount Sinai
Contact Nicola F Tavella, MPH
Phone 212-241-3888
Email nicola.tavella@mssm.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - Multiple gestation - Fetal anomalies - Gestational diabetes or pregestational diabetes.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• USCOM
Device that measures how much blood is being pumped in and out of the heart.

Locations
Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systemic vascular resistance obtained from USCOM Cardiac output related to systemic vascular resistance (SVR) obtained from the USCOM device. SVR is an indicator of general resistance experienced within the circulatory system and is correlated with an array of cardiac related adverse health outcomes. The USCOM device uses noninvasive ultrasonographic technology to determine SVR at the time of prenatal ultrasound. every 2-4 weeks at time of prenatal ultrasound, until the end of pregnancy
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