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

Prenatal Diagnosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03201666
• Other study ID #: TZ201607
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2017
• Last updated: June 28, 2017
• Start date: July 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: Taizhou Hospital
• Contact: YiYang Zhu, MD
• Phone: +8613819630569
• Email: zuyy[@]tzhospital.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chromosome Aberrations
• Chromosome Disorders
• Prenatal Diagnosis

Locations

Country	Name	City	State
China	Taizhou Hospital of Zhejiang province	Taizhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
YiYang Zhu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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