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A novel noninvasive prenatal chromosome aneuploidy screening technique based on HLPA

A novel noninvasive prenatal chromosome aneuploidy screening technique based on HLPA

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036942
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-28

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

Conditions

birth defect

Interventions

Gold Standard:NIPT
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Sponsors

International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong university
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Prenatal screening (such as serological screening and imaging examination) indicates critical risk of common chromosome aneuploidy (i.e., down's screening risk value is 1/270-1/1000, trisomy 18 and Trisomy 13 risk value is 1/350-1/1000); (2) There are contraindications to interventional prenatal diagnosis (threatened abortion, fever, infection, etc.); (3) Patients with large gestational age and missed the serological screening time but hoped to reduce the risk of common aneuploidy.

Exclusion criteria

Exclusion criteria: (1) Multiple pregnancies; (2) The pregnant woman is a patient with chromosomal abnormalities; (3) The pregnant woman has invasive surgery experience on the day of blood drawing; (4) The pregnant woman has received allogeneic blood transfusion, transplantation surgery, stem cell therapy and other experiences; (5) Reject the cffDNA tester.

Design outcomes

Primary

MeasureTime frame
21, 18, 13 trisomy and X monomer risk;

Countries

China

Contacts

Public ContactChenming Xu

International Peace Maternity and Child Health Hospital

xuchenm@163.com18017310187

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026