Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies

This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

Study Overview

• Status: Unknown
• Conditions: Prenatal Diagnosis

Detailed Description

Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies.

Design: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited.

Methods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting.

Statistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: YiYang Zhu, MD; Phone Number: +8613819630569; Email: zuyy@tzhospital.com

Study Locations

• China
  • Zhejiang
    • Taizhou, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: YiYang Zhu, MD; Phone Number: +8613819630569; Email: zuyy@tzhospital.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

pregnant women who needed amniocenteses were recruited during the study period

Description

Inclusion Criteria:

1. pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal.
2. only singleton were included

Exclusion Criteria:

1. women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease.
2. Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of NIPT for prenatal diagnosing chromosomal anomalies	sensitive, false negative rate, and false positive rate of NIPT compared with CMA	July,2016-July, 2017

Collaborators and Investigators

• Sponsor: YiYang Zhu
• Investigators: Study Director: YiYang Zhu, MD, prenatal doagnosis center of taizhou city

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: prenatal diagnosis; non-invasive prenatal tests; chromosome microarray analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Genetic Diseases, Inborn; Chromosome Disorders; Chromosome Aberrations
• Other Study ID Numbers: TZ201607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No