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

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

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?

Study Overview

• Status: Terminated
• Conditions: Pregnancy; Fetal Aneuploidy

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 Type: Observational
• Enrollment (Actual): 350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women presenting for a comprehensive ultrasound at approximately 20 weeks

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	completion of pregnancy

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Burton Rochelson, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Aneuploidy
• Other Study ID Numbers: IRB 07-077