USCOM in Newly Diagnosed FGR Cases

NCT06343051 | Recruiting FDA Device

• 1 other identifier: STUDY-23-01681
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Growth Restriction; USCOM

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fetal Growth Restriction diagnosed > 27w6d gestation

Patients with a new diagnosis of fetal growth restriction after 27 weeks 6 days' gestation.

Device: USCOM

Interventions

USCOM DEVICE

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

Fetal Growth Restriction diagnosed > 27w6d gestation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 may not qualify if:

• Multiple gestation
• Fetal anomalies
• Gestational diabetes or pregestational diabetes.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicola F Tavella, MPH

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

• Rachel J Meislin, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola F Tavella, MPH

CONTACT

212-241-3888; nicola.tavella@mssm.edu

Allison Perelman, MD

CONTACT

allison.perelman@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 2, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)