Biochemical Markers and 2 and 3D Ultrasound to ID Maternal & Fetal Complications

Northwell Health350 enrolled

Overview

Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?

Pts will be consented upon presenting to the department for a comprehensive ultrasound.The 3D picture is the only part of the study that is not part of standard obstetrical care.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Pregnancy Fetal Aneuploidy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women at approximately 20 weeks * ages 18-50 * singleton pregnancy * plans to deliver at North Shore University Hosp * completed step-wise sequential screening Exclusion Criteria: * multifetal gestation * minors * patients who have undergone diagnostic genetic testing * incarcerated patients * intention to deliver at a hospital other than North Shore University hosp

Outcomes

Primary Outcomes

Correlation of geometric morphometric analysis of fetal brow to 10 soft markers

In patients who have undergone step-wise sequential screening, how often will the evaluation of 10 midtrimester sonographic soft markers of aneuploidy such that the recommendation regarding invasive diagnostic testing be changed?

Time frame: completion of pregnancy

Data from ClinicalTrials.gov

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