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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01404221
• Other study ID #: IRB 07-077
• Status: Terminated
• Phase: N/A
• First received: July 26, 2011
• Last updated: April 13, 2015
• Start date: March 2009
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 350
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneuploidy
• Fetal Aneuploidy
• Pregnancy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No