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

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ClinicalTrials.gov Identifier: NCT01404221
Recruitment Status : Terminated (No safety issues. Need to rewrite protocol)
First Posted : July 27, 2011
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Burt Rochelson, North Shore Long Island Jewish Health System

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?

Condition or disease
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
Actual Enrollment : 350 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015



Primary Outcome Measures :
  1. Correlation of geometric morphometric analysis of fetal brow to 10 soft markers [ Time Frame: 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?



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404221


Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Burton Rochelson, MD Northwell Health

Responsible Party: Burt Rochelson, Investigator, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01404221     History of Changes
Other Study ID Numbers: IRB 07-077
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes