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

N/ANot Yet RecruitingNCT07526662

Yihua He,MD1,000 enrolled

Overview

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.

Perinatal cardiovascular health poses significant threats to maternal and fetal safety. Pregnancy-associated heart disease remains the leading cause of non-obstetric maternal mortality in China. While conventional assessments rely on static and intermittent monitoring, dynamic changes in cardiac function during pregnancy often go undetected, leading to missed opportunities for early intervention. Fetal congenital heart disease (CHD) and autoimmune-related fetal complete heart block (CHB) are major causes of adverse perinatal outcomes. Current diagnostic methods, primarily relying on fetal echocardiography, struggle to detect early electrophysiological abnormalities, resulting in delayed warning times. This study integrates non-invasive wearable technology to dynamically collect maternal-fetal heart sound and ECG signals. It aims to establish normal reference standards, screen sensitive early warning indicators, construct predictive models for perinatal adverse events, and finally develop a clinical risk stratification workflow. Signal acquisition was initiated at the following gestational ages: fECG from approximately 12 weeks of gestation, fPCG from approximately 16 weeks of gestation, and maternal signals (mECG and mPCG) from the time of enrollment. All signals were acquired serially until delivery.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Pregnancy-Associated Heart Disease Fetal Congenital Heart Disease

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maternal Major Adverse Cardiac Events (MACE)

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.

Time frame: From study enrollment to 6 weeks postpartum

Fetal Congenital Heart Disease (CHD) Progression

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.

Time frame: 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)

Development of second-degree or third-degree atrioventricular block in fetuses of anti-SSA/SSB antibody-positive mothers, detected by serial fetal ECG monitoring.

Time frame: From 16 weeks of gestation to delivery

Secondary Outcomes

Emergency Cesarean Section Due to Cardiac Indications

Unplanned cesarean delivery performed due to maternal cardiac decompensation, refractory arrhythmia, or fetal distress related to cardiac disease.

Time frame: From study enrollment until the date of delivery or study withdrawal, whichever came first, assessed up to approximately 34 weeks.

Preterm Birth

Delivery occurring before 37 weeks of gestation, including spontaneous preterm labor and medically indicated preterm delivery.

Time frame: At delivery

Low Birth Weight

Birth weight less than 2500 grams, as measured at delivery.

Time frame: At delivery

Multimodal cardiac signal acquisition feasibility and fetal cardiac acoustic feature characterization

Including: (1) four-channel simultaneous signal acquisition success rate; (2) signal quality metrics for mECG, fECG, mPCG, and fPCG; (3) quantitative differences in fPCG acoustic features between CHD-affected and normal fetuses, as assessed by algorithm analysis.

Time frame: From study enrollment until delivery or study withdrawal, whichever came first, assessed up to approximately 28 weeks