Not Yet RecruitingNot Applicable

Maternal-Fetal Heart Sound/Electrocardiogram Monitoring and Cardiac Risk Early Warning

China1,000 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. Pregnant women aged 18 to 45 years with singleton pregnancy;
✓. For maternal groups: diagnosed with heart disease (congenital, valvular, or cardiomyopathy) or healthy without cardiac disease;
✓. For fetal groups: diagnosed with congenital heart disease, anti-Ro/SSA antibody positive status, or normal cardiac structure;
✓. Able to cooperate with non-invasive monitoring and follow-up procedures;
✓. Voluntary written informed consent provided prior to enrollment.

Exclusion criteria

✕. Multiple pregnancy;
✕. Severe skin disease or thoracic deformity preventing placement of monitoring sensors;
✕. History of malignancy, severe hepatic or renal dysfunction;
✕. Inability to complete follow-up visits or monitoring;
✕. Contraindications to non-invasive monitoring procedures.

What they're measuring

Maternal Major Adverse Cardiac Events (MACE)

Timeframe: From study enrollment to 6 weeks postpartum

Fetal Congenital Heart Disease (CHD) Progression

Timeframe: 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.

Autoimmune-Related Fetal Complete Heart Block (CHB)

Timeframe: From 16 weeks of gestation to delivery

Trial details

NCT IDNCT07526662

SponsorYihua He,MD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-05

Contact for this trial

yihua he

+86 18910778673 yihuaheecho@163.com

View on ClinicalTrials.gov More Pregnancy-Associated Heart Disease trials