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Prospective cohort study on the role of one-stop combined screening in early pregnancy in the prevention and control of birth defects

Prospective cohort study on the role of one-stop combined screening in early pregnancy in the prevention and control of birth defects

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111702
Enrollment
Unknown
Registered
2025-11-04
Start date
2024-07-31
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Fetal chromosomal disorders Fetal anatomy screening

Interventions

Gold Standard:Screening of fetal structure in the first trimester: Nuchal translucency (NT) and structural malformations of the fetus. Serum biomarker: pregnancy-associated plasma protein-A (PAPP-A).
Index test:1. Serum biomarker: pregnancy-associated plasma protein-A (PAPP-A). Free ß-hCG (ß-human Chorionic Gonadotropin) 2. Fetal anatomical screening in the first trimester 3. Fetal structure scree

Sponsors

Hefei Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. No previous history of mental disorders, able to communicate freely; 2. Voluntarily agreed to join the cohort, and pregnant women (or their immediate family members) have signed the informed consent form. 3. Good compliance with follow-up.

Exclusion criteria

Exclusion criteria: 1. Has mental illnesses such as schizophrenia or depression; 2. Clinical data is incomplete or difficult to obtain; 3. Has not obtained informed consent and signed the informed consent form.

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactZheng mingming

Hefei Maternal and Child Health Hospital

m_m_zheng@163.com+86 138 1384 9845

Outcome results

None listed

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