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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fetal Growth Restriction diagnosed > 27w6d gestation | Patients with a new diagnosis of fetal growth restriction after 27 weeks 6 days' gestation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| USCOM | Device | Device that measures how much blood is being pumped in and out of the heart. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed fetal growth restriction at greater than 27 weeks 6 days' gestation will be eligible to enroll in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola F Tavella, MPH | Contact | 212-241-3888 | nicola.tavella@mssm.edu | |
| Allison Perelman, MD | Contact | allison.perelman@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
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.
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |