Study Stopped
No safety issues. Need to rewrite protocol
Biochemical Markers and 2 and 3D Ultrasound to ID Maternal & Fetal Complications
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
1 other identifier
observational
350
0 countries
N/A
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2009
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 26, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 14, 2015
April 1, 2015
5.9 years
July 26, 2011
April 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Pregnant women presenting for a comprehensive ultrasound at approximately 20 weeks
You may qualify if:
- Pregnant women at approximately 20 weeks
- ages 18-50
- singleton pregnancy
- plans to deliver at North Shore University Hosp
- completed step-wise sequential screening
You may not qualify if:
- multifetal gestation
- minors
- patients who have undergone diagnostic genetic testing
- incarcerated patients
- intention to deliver at a hospital other than North Shore University hosp
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Officials
- PRINCIPAL INVESTIGATOR
Burton Rochelson, MD
Northwell Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator, MD
Study Record Dates
First Submitted
July 26, 2011
First Posted
July 27, 2011
Study Start
March 1, 2009
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 14, 2015
Record last verified: 2015-04