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Screening of early diagnostic markers for fetal congenital heart disease based on maternal serum exosomes

Screening of early diagnostic markers for fetal congenital heart disease based on maternal serum exosomes

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037051
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
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

Congenital heart disease

Interventions

Gold Standard:Color Doppler
serum&#32

Sponsors

The International Peace Maternity & Child Health Hospital of China Welfare Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Serum samples of pregnant women at 12-16 weeks and 24-28 weeks of gestation were collected and followed up to the birth of the newborn. The case data, the results of ultrasound and the data of birth defects were retrospectively inquired. 2. Case group: The serum of pregnant women with congenital heart disease (tetralogy of Fallot, ventricular septal defect and atrial septal defect) in different gestational periods were selected; 3. Control group: The same pregnancy serum of normal pregnant women excluding preeclampsia, gestational diabetes mellitus, gestational hypertension and other pregnancy complications was used, 4. Research period was divided into two periods, namely 12-16 weeks of gestation and 24-28 weeks of gestation; each pregnancy period included four groups, namely tetralogy of Fallot group, ventricular septal defect group, atrial septal defect group and fetal group without obvious abnormality (tracking to postpartum).

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Maternal serum exosome miRNA;Sensitivity;Specificity;Specificity;Specificity;

Countries

China

Contacts

Public ContactHaiou Yang

The International Peace Maternity & Child Health Hospital of China Welfare Institute

haiouyang2006@126.com+86 13764593907

Outcome results

None listed

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