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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT02969174
Other study ID # ShangjiTongjiHsxk
Secondary ID
Status Approved for marketing
Phase N/A
First received November 3, 2016
Last updated November 17, 2016

Study information

Verified date November 2016
Source Shanghai Tongji Hospital, Tongji University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Science and Technology Commission of Shanghai Municipality
Study type Expanded Access

Clinical Trial Summary

To establish a genotyping and extraction technology of non invasive prenatal diagnosis for fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.

To achieve prenatal accurate identification of fetal blood group genotypes,and provide credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease of newborn (HDN).


Description:

Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 12 Weeks to 38 Weeks
Eligibility Inclusion Criteria:

blood samples of pregnant couples,gender/nation/region is unlimited.

Exclusion Criteria:

adipose or hemolytic samples,overdue samples,unidentified samples

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Other:
zimin Lu,Guo Sa
chengzhong Liu

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine