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Clinical validity of fetal chromosome aneuploidy ( T21, T18, T13) non-invasive prenatal screening by digital PCR

Clinical validity of fetal chromosome aneuploidy ( T21, T18, T13) non-invasive prenatal screening by digital PCR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069694
Enrollment
Unknown
Registered
2023-03-23
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

birth defects

Interventions

Birth defects (Digital PCR-NIPT technology):None

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: To ensure that the proportion of fetuses with positive fetal chromosomal trisomies is maintained, this study will be conducted on the following special groups of pregnant women. (1) Pregnant women with a serological screening result of "high risk of Down's syndrome (risk value >1/270)" or "high risk of trisomy 18 (risk value >1/350)". (2) Pregnant women of advanced age. (3) Pregnant women with NGS-NIPT screening results of "T21 high risk", "T18 high risk", or "T13 high risk".

Exclusion criteria

Exclusion criteria: (1) Pregnant women without complications such as malignancy. (2) Samples with very low concentrations of maternal peripheral blood DNA. (3) Other conditions considered by the investigator as unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
T21,T18,T13 Conformity;

Secondary

MeasureTime frame
T21,T18,T13 Sensitivity;T21,T18,T13 Specificity;

Countries

China

Contacts

Public ContactXu Chenming

Obstetrics & Gynecology Hospital of Fudan University

chenming_xu2006@163.com+86 21 64073897

Outcome results

None listed

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