Using ultrasound to measure heart function in pregnancies with fetal growth restriction
Ultrasound Hemodynamic Assessment in Newly Diagnosed Fetal Growth Restriction: A Pilot Study
This study is testing a special ultrasound tool to see if it can help measure heart function in pregnant women whose babies are not growing as expected.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06343051 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the use of an ultrasound measurement system called USCOM in patients who have been newly diagnosed with fetal growth restriction (FGR). The study focuses on understanding how effectively this technology can measure the blood flow in and out of the heart, which is crucial for assessing heart function during pregnancy. By monitoring these parameters, the research seeks to provide insights into the management of pregnancies affected by FGR. The study will include pregnant patients in their third trimester with specific criteria for inclusion.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant patients diagnosed with fetal growth restriction in the third trimester.
Not a fit: Patients with multiple gestations, fetal anomalies, or diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and management of pregnancies affected by fetal growth restriction, potentially improving outcomes for both mothers and babies.
How similar studies have performed: While the use of ultrasound in pregnancy is common, the specific application of USCOM for fetal growth restriction is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rachel J Meislin, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Nicola F Tavella, MPH
- Email: nicola.tavella@mssm.edu
- Phone: 212-241-3888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.