Maternal-Fetal Heart Sound/Electrocardiogram Monitoring and Cardiac Risk Early Warning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy-Associated Heart Disease, Fetal Congenital Heart Disease, Autoimmune-Related Fetal Heart Block, Perinatal Adverse Events. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on Dynamic Acquisition of Maternal-Fetal Heart Sound and Electrocardiogram and Early Warning and Risk Stratification of Perinatal Cardiac Adverse Events
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.
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.
Primary outcome measures
- Maternal Major Adverse Cardiac Events (MACE) [Time frame: From study enrollment to 6 weeks postpartum]
- Fetal Congenital Heart Disease (CHD) Progression [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) [Time frame: From 16 weeks of gestation to delivery]
Secondary outcome measures (4)
- Emergency Cesarean Section Due to Cardiac Indications [Time frame: From study enrollment until the date of delivery or study withdrawal, whichever came first, assessed up to approximately 34 weeks.]
- Preterm Birth [Time frame: At delivery]
- Low Birth Weight [Time frame: At delivery]
- Multimodal cardiac signal acquisition feasibility and fetal cardiac acoustic feature characterization [Time frame: From study enrollment until delivery or study withdrawal, whichever came first, assessed up to approximately 28 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing An Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07526662 · PERI-CARDIO-MF-01