Clinical evaluation of MGC-NIPS method for noninvasive prenatal screening

Not Applicable

• Conditions: high risk pregnancy; non invasive prenatal screening; sensitivity; specificity; trisomy

• Registration Number: TCTR20190708001
• Lead Sponsor: Medical Genome Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-08
• Study Completion: 2020-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 1320

Inclusion Criteria

high risk pregnant woman who undergoing amniocentesis

Exclusion Criteria

multiple pregnancy
cancer
receiving blood product

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
accuracy of MGC-NIPS end of gold standard test sensitivity, specificity comparing to karyotyping

Secondary Outcome Measures

Name	Time	Method
Immunologic response 24 weeks CD4 change,eGFR 24 weeks eGFR change,Proximal tubular function 24 weeks FEPO4, TmP/GFR, FEUA, UPCR, ,Lipid profiles 24 weeks Total cholesterl, Triglycerides, HDL, LD