This is a prospective observational cohort study conducted at Beijing Anzhen Hospital. The study aims to establish reference ranges of heart sound and electrocardiogram (ECG) parameters for both mothers and fetuses. It seeks to develop early warning models for maternal adverse cardiac events, fetal congenital heart disease progression, and autoimmune-related fetal heart block, thereby building a comprehensive maternal-fetal integrated risk stratification system.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Pregnant women aged 18 to 45 years with singleton pregnancy;
2. For maternal groups: diagnosed with heart disease (congenital, valvular, or cardiomyopathy) or healthy without cardiac disease;
3. For fetal groups: diagnosed with congenital heart disease, anti-Ro/SSA antibody positive status, or normal cardiac structure;
4. Able to cooperate with non-invasive monitoring and follow-up procedures;
5. Voluntary written informed consent provided prior to enrollment.
Exclusion Criteria:
1. Multiple pregnancy;
2. Severe skin disease or thoracic deformity preventing placement of monitoring sensors;
3. History of malignancy, severe hepatic or renal dysfunction;
4. Inability to complete follow-up visits or monitoring;
5. Contraindications to non-invasive monitoring procedures.
Primary outcome measure(s)
Maternal Major Adverse Cardiac Events (MACE) — From study enrollment to 6 weeks postpartum Composite endpoint including cardiac death, cardiac arrest, heart failure requiring hospitalization, sustained ventricular arrhythmia, stroke, myocardial infarction, and aortic dissection occurring during the study period.
Fetal Congenital Heart Disease (CHD) Progression — From first signal acquisition (fECG at 12 weeks, fPCG at 16 weeks) until delivery or withdrawal, with serial fetal echocardiography throughout; assessed up to 28 weeks. Composite endpoint including fetal hemodynamic deterioration, right ventricular dysfunction, hydrops fetalis, or delivery before 37 weeks due to worsening CHD, as assessed by serial fetal echocardiography.
Autoimmune-Related Fetal Complete Heart Block (CHB) — From 16 weeks of gestation to delivery Development of second-degree or third-degree atrioventricular block in fetuses of anti-SSA/SSB antibody-positive mothers, detected by serial fetal ECG monitoring.
Trial sites (1)
Facility
City
Region
Status
Beijing An Hospital, Capital Medical University
Beijing
China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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