USCOM in Newly Diagnosed FGR Cases (USCOM FGR)

Ultrasound Hemodynamic Assessment in Newly Diagnosed Fetal Growth Restriction: a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Growth Restriction; USCOM
• Intervention / Treatment: Device: USCOM

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Allison Perelman, MD; Email: allison.perelman@mssm.edu
• Study Contact Backup: Name: Nicola F Tavella, MPH; Phone Number: 212-241-3888; Email: nicola.tavella@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Nicola F Tavella, MPH; Phone Number: 2122413888; Email: nicola.tavella@mssm.edu
      • Contact: Rachel J Meislin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed fetal growth restriction at greater than 27 weeks 6 days' gestation will be eligible to enroll in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fetal Growth Restriction diagnosed > 27w6d gestation; Patients with a new diagnosis of fetal growth restriction after 27 weeks 6 days' gestation.	Device: USCOM; Device that measures how much blood is being pumped in and out of the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Study Director: Nicola F Tavella, MPH, Icahn School Of Medicine At Mount Sinai; Principal Investigator: Rachel J Meislin, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Growth Disorders; Fetal Growth Retardation
• Other Study ID Numbers: STUDY-23-01681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to Nicola.tavella@mssm.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No