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

This study has been terminated.
(No safety issues. Need to rewrite protocol)
Information provided by (Responsible Party):
Burt Rochelson, North Shore Long Island Jewish Health System Identifier:
First received: July 26, 2011
Last updated: April 13, 2015
Last verified: April 2015

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?

Fetal Aneuploidy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Correlation of geometric morphometric analysis of fetal brow to 10 soft markers [ Time Frame: completion of pregnancy ] [ Designated as safety issue: No ]
    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?

Enrollment: 350
Study Start Date: March 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women presenting for a comprehensive ultrasound at approximately 20 weeks


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01404221

Sponsors and Collaborators
North Shore Long Island Jewish Health System
Principal Investigator: Burton Rochelson, MD North Shore-LIJ Health System
  More Information

No publications provided

Responsible Party: Burt Rochelson, Investigator, MD, North Shore Long Island Jewish Health System Identifier: NCT01404221     History of Changes
Other Study ID Numbers: IRB 07-077
Study First Received: July 26, 2011
Last Updated: April 13, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chromosome Aberrations
Pathologic Processes processed this record on October 09, 2015