NCT03201666

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

June 26, 2017

Last Update Submit

June 28, 2017

Conditions

Prenatal Diagnosis

Keywords

prenatal diagnosisnon-invasive prenatal testschromosome microarray analysis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women who needed amniocenteses were recruited during the study period

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taizhou Hospital of Zhejiang province

Taizhou, Zhejiang, 317000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sample1.maternal peripheral blood，which used for extracted fetal free DNA for NIPT examination Sample2.amniotic fluid, which used for karyotyping and CMA analysis.

Study Officials

  • YiYang Zhu, MD

    prenatal doagnosis center of taizhou city

    STUDY DIRECTOR

Central Study Contacts

YiYang Zhu, MD

CONTACT

+8613819630569zuyy@tzhospital.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director,Clinical dean of Prenatal Diagnosis Center

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 28, 2017

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 31, 2017

Last Updated

June 29, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)