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NCT Number: NCT06343051

USCOM in Newly Diagnosed FGR Cases

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital

New York, 10029, United States

Location status: Recruiting

Location contact

Nicola F Tavella, MPH

CONTACT

[email protected]

2122413888

Rachel J Meislin

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

USCOM

Device

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

Primary outcomes

  1. Systemic vascular resistance obtained from USCOM

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Perelman, MD

CONTACT

[email protected]

Nicola F Tavella, MPH

CONTACT

[email protected]

212-241-3888

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Acronym: USCOM FGR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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