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

Terminated

• Conditions: Pregnancy; Fetal Aneuploidy

• Registration Number: NCT01404221
• Lead Sponsor: Northwell Health

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of geometric morphometric analysis of fetal brow to 10 soft markers	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?