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

NCT ID: NCT01404221

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-02-28

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Pregnancy Fetal Aneuploidy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Burt Rochelson

Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burton Rochelson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Other Identifiers

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IRB 07-077

Identifier Type: -

Identifier Source: org_study_id

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