TriMax 428 Noninvasive Prenatal Screening of Fetal Chromosome Diseases: a Clinical Multi-center Study.

The Evaluation of the Clinical Value of Expanded Noninvasive Prenatal Testing (NIPT-Plus)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900025429

Enrollment

Unknown

Registered

2019-08-26

Start date

2019-08-31

Completion date

Unknown

Last updated

2019-08-27

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

Conditions

Chromosome aneuploidies and chromosome microdeletion/microduplication disorders

Interventions

Gold Standard:invasive prenatal diagnostic technologies

Index test:TriMax 428

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The pregnant women diagnosed as carrying fetus with chromosome abnormalities (interpreted as pathogenic or likely pathogenic by ACMG guideline) by invasive prenatal diagnostic technologies (including CMA, CNV-seq and FISH).

Exclusion criteria

Exclusion criteria: 1. Severe obesity (BMI > 40), or body weight > 90 kg; 2. Triplets or selective reduction of triplet pregnancies by IVF or other methods; 3. Twin or multiple pregnancies; 4. Gestational week < 12 weeks; 5. Receiving allogeneic blood transfusion or transplantation within one year; 6. Malignant tumor during pregnancy.

Design outcomes

Primary

Measure	Time frame
Positive detection rate;False negative rate;Coincidence rate;Precision of CNV detection;	—

Countries

China

Contacts

Public ContactZhu Baosheng

First People's Hospital of Yunnan Province

bszhu@aliyun.com+86 13013318166

Outcome results

None listed

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