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New technology and clinical study on non-invasive prenatal synchronous screening for multiple types of genetic diseases

New technology and clinical study on non-invasive prenatal synchronous screening for multiple types of genetic diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086541
Enrollment
Unknown
Registered
2024-07-04
Start date
2024-06-25
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

birth defects

Interventions

high risk pregnant woman:NA
General pregnant women:NA

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: The prospective cohort of general pregnant women will be defined as having a singleton pregnancy between 12 and 22+6 weeks of gestation, being over 20 years of age, and receiving a molecular diagnostic; for the cohort of high-risk pregnant women, enrollment will be defined as having a structural abnormality on ultrasound screening of the fetus, having a high risk on serologic prenatal screening, having a family history of hereditary disorders, or having other risk factors.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (i) complications of other pregnancy complications; (ii) severe cardiac, hepatic and renal insufficiency; (iii) patients with autoimmune diseases and malignant neoplastic diseases. Pregnant women with abnormalities due to chromosomal, congenital anomalies, preterm birth and multiple pregnancies were excluded.

Design outcomes

Primary

MeasureTime frame
sensitivity;

Secondary

MeasureTime frame
specificity;Positive predictive value;Negative predictive value;

Countries

China

Contacts

Public ContactXu Chenming

The Obstetrics & Gynecology Hospital of Fudan University

xuchenm@163.com+86 173 0170 0197

Outcome results

None listed

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