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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01404221

Enrollment

350

Registered

2011-07-27

Start date

2009-03-31

Completion date

2015-02-28

Last updated

2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Aneuploidy, Pregnancy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation of geometric morphometric analysis of fetal brow to 10 soft markers	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?

Outcome results