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Status unknownNCT03201666Updated Jun 29, 2017

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

An observational study in Prenatal Diagnosis, sponsored by YiYang Zhu. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2017-06-29.

Sponsored by YiYang Zhu · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Prenatal Diagnosis

Keywords

  • prenatal diagnosis
  • non-invasive prenatal tests
  • chromosome microarray analysis
03

In context

Chromosome Disorders

54 studies on the registry are indexed under Chromosome Disorders; 7 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 310 across 34 observational studies indexed under Chromosome Disorders.

Browse Chromosome Disorders studies →

Lead sponsor

YiYang Zhu is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

pregnant women who needed amniocenteses were recruited during the study period

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. accuracy of NIPT for prenatal diagnosing chromosomal anomalies

    sensitive, false negative rate, and false positive rate of NIPT compared with CMA

    Time frame: July,2016-July, 2017

07

Study locations

1 of 1 sites recruiting
  • Taizhou Hospital of Zhejiang province
    Taizhou, Zhejiang 317000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03201666
Lead sponsor
YiYang Zhu
Responsible party
YiYang Zhu (Director,Clinical dean of Prenatal Diagnosis Center, Taizhou Hospital) — Sponsor-investigator
First posted
Jun 28, 2017
Start date
Jul 1, 2016
Primary completion
Jul 1, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Jun 29, 2017

Study contacts

YiYang Zhu, MD
Contact
zuyy@tzhospital.com
+8613819630569
YiYang Zhu, MD
study director · prenatal doagnosis center of taizhou city

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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