USCOM in Newly Diagnosed FGR Cases

Recruiting

• Conditions: USCOM; Fetal Growth Restriction
• Interventions: Device: USCOM

• Registration Number: NCT06343051
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-02
• Status Verified: 2024-07
• Study Start: 2024-07-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fetal Growth Restriction diagnosed > 27w6d gestation	USCOM	Patients with a new diagnosis of fetal growth restriction after 27 weeks 6 days' gestation.

Primary Outcome Measures

Name	Time	Method
Systemic vascular resistance obtained from USCOM	every 2-4 weeks at time of prenatal ultrasound, until the end of pregnancy	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.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States