Study on Dynamic Acquisition of Maternal-Fetal Heart Sound and Electrocardiogram and Early Warning and Risk Stratification of Perinatal Cardiac Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Maternal Major Adverse Cardiac Events (MACE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pregnant Women with Heart Disease
This group includes pregnant women with pre-existing cardiac conditions (e.g., congenital heart disease, valvular heart disease, cardiomyopathy, arrhythmia). They undergo serial non-invasive monitoring of cardiac function (via heart sound and ECG) throughout pregnancy and postpartum to identify early signs of decompensation.
Healthy Pregnant Women (Control)
This control group includes pregnant women without known cardiac disease, matched for age and gestational age. They undergo the same non-invasive cardiac monitoring protocol as the study group to establish baseline reference values.
Fetuses with Congenital Heart Disease (CHD)
This group includes fetuses diagnosed with congenital heart disease via prenatal ultrasound. Serial non-invasive monitoring (via fetal ECG and heart sound) is performed to track disease progression and identify early signs of hemodynamic compromise.
Fetuses of Anti-Ro/SSA Positive Mothers
This high-risk group includes fetuses of mothers with anti-Ro/SSA antibodies, who are at increased risk of developing congenital heart block. Serial fetal ECG monitoring is performed from 16 weeks of gestation to detect early signs of atrioventricular conduction abnormalities.
Healthy Singleton Fetuses (Control)
This control group includes fetuses with normal cardiac anatomy on prenatal ultrasound, matched for gestational age. They undergo the same non-invasive monitoring protocol as the study groups to establish normal reference values for fetal cardiac parameters.
结局指标
主要结局
Maternal Major Adverse Cardiac Events (MACE)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Emergency Cesarean Section Due to Cardiac Indications(From study enrollment until the date of delivery or study withdrawal, whichever came first, assessed up to approximately 34 weeks.)
- Preterm Birth(At delivery)
- Low Birth Weight(At delivery)
- Multimodal cardiac signal acquisition feasibility and fetal cardiac acoustic feature characterization(From study enrollment until delivery or study withdrawal, whichever came first, assessed up to approximately 28 weeks)
研究者
Yihua He,MD
Chief Physician, Director of Echocardiography Medical Center, Director of Beijing Key Laboratory of Maternal-Fetus Medicine in Fetal Heart Disease, Professor
Beijing Anzhen Hospital