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

NCT ID: NCT03201666

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Prenatal Diagnosis

Keywords

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prenatal diagnosis non-invasive prenatal tests chromosome microarray analysis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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YiYang Zhu

OTHER

Sponsor Role lead

Responsible Party

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YiYang Zhu

Director,Clinical dean of Prenatal Diagnosis Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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YiYang Zhu, MD

Role: STUDY_DIRECTOR

prenatal doagnosis center of taizhou city

Locations

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Taizhou Hospital of Zhejiang province

Taizhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YiYang Zhu, MD

Role: CONTACT

Phone: +8613819630569

Email: [email protected]

Facility Contacts

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YiYang Zhu, MD

Role: primary

Other Identifiers

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TZ201607

Identifier Type: -

Identifier Source: org_study_id