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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Burt Rochelson, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01404221
First received: July 26, 2011
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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
Pregnancy
Fetal Status

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

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?


Estimated Enrollment: 2000
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404221

Locations
United States, New York
Prenatal Testing department, North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
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
ClinicalTrials.gov Identifier: NCT01404221     History of Changes
Other Study ID Numbers: IRB 07-077
Study First Received: July 26, 2011
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 28, 2014