Biochemical Markers and 2 and 3D Ultrasound to ID Materna... | NCT01404221

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

NCT01404221

Sponsor

Northwell Health

Status

Terminated

Last Update Posted

Apr 14, 2015Estimated

Enrollment

350Actual

Phase

Not provided

Conditions

Pregnancy
Fetal Aneuploidy

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No safety issues. Need to rewrite protocol

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jul 26, 2011

First Submission Date that Met QC Criteria

Jul 26, 2011

First Posted Date

Jul 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2015

Last Update Posted Date

Apr 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pregnant women presenting for a comprehensive ultrasound at approximately 20 weeks

Sampling Method

Non-Probability Sample