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NCT01404221 Clinical Trial

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
Secondary ID
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

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
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