The Combination of Biochemical Markers and Two and Three Dimensional Ultrasound Using Geometric Morphometrics in the Identification of Congenital Anomalies and Maternal or Fetal Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Northwell Health
- Enrollment
- 350
- Primary Endpoint
- Correlation of geometric morphometric analysis of fetal brow to 10 soft markers
Study Overview
Brief Summary
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?
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •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
Time Frame: completion of pregnancy
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?
Secondary Outcomes
No secondary outcomes reported
Investigators
Burt Rochelson
Investigator, MD
Northwell Health