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

NCT07526662 | Not Yet Recruiting

• 1 other identifier: PERI-CARDIO-MF-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy-Associated Heart Disease; Fetal Congenital Heart Disease; Autoimmune-Related Fetal Heart Block; Perinatal Adverse Events

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yihua He,MD: lead

Study Sites (1)

Beijing An Hospital, Capital Medical University

Beijing, 100011, China

Location

Central Study Contacts

yihua he

CONTACT

+86 18910778673; yihuaheecho@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Director of Echocardiography Medical Center, Director of Beijing Key Laboratory of Maternal-Fetus Medicine in Fetal Heart Disease, Professor

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)