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

Study on Dynamic Acquisition of Maternal-Fetal Heart Sound and Electrocardiogram and Early Warning and Risk Stratification of Perinatal Cardiac Adverse Events

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy-Associated Heart Disease; Fetal Congenital Heart Disease; Autoimmune-Related Fetal Heart Block; Perinatal Adverse Events

Detailed Description

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 (Estimated): 1000

Contacts and Locations

• Study Contact: Name: yihua he; Phone Number: +86 18910778673; Email: yihuaheecho@163.com

Study Locations

• China
  • Beijing, China, 100011
    • Beijing An Hospital, Capital Medical University
    • Contact: yihua he; Phone Number: +86 18910778673; Email: yihuaheecho@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study population consists of pregnant women aged 18-45 years with singleton pregnancies, including those with pregnancy-associated heart disease, anti-Ro/SSA antibody positivity, and healthy controls, and their fetuses, enrolled at Beijing Anzhen Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From 16 weeks of gestation to delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At delivery
Low Birth Weight	Birth weight less than 2500 grams, as measured at delivery.	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.	From study enrollment until delivery or study withdrawal, whichever came first, assessed up to approximately 28 weeks

Collaborators and Investigators

• Sponsor: Yihua He,MD

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PERI-CARDIO-MF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) from this study will not be shared publicly due to patient privacy regulations, institutional review board requirements, and the sensitive nature of maternal and fetal health data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No