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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03201666

Enrollment

1000

Registered

2017-06-28

Start date

2016-07-01

Completion date

2017-12-31

Last updated

2017-06-29

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

Conditions

Prenatal Diagnosis

Keywords

prenatal diagnosis, non-invasive prenatal tests, chromosome microarray analysis

Brief 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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactYiYang Zhu, MD

zuyy@tzhospital.com+8613819630569

Outcome results