USCOM in Newly Diagnosed FGR Cases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Multiple gestation
Fetal anomalies
Gestational diabetes or pregestational diabetes.
Trial population
Patients with newly diagnosed fetal growth restriction at greater than 27 weeks 6 days' gestation will be eligible to enroll in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
USCOM
DeviceDevice that measures how much blood is being pumped in and out of the heart.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Fetal Growth Restriction diagnosed > 27w6d gestation1 intervention
Trial outcomes
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.
Time frame
every 2-4 weeks at time of prenatal ultrasound, until the end of pregnancySponsors and contacts
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Source ClinicalTrials.gov