Pregnancy-Associated Heart DiseaseNCT07526662
Maternal-Fetal Heart Sound/Electrocardiogram Monitoring and Cardiac Risk Early Warning
An observational study of Pregnancy-Associated Heart Disease and Fetal Congenital Heart Disease, run by Yihua He,MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy-Associated Heart Disease, Fetal Congenital Heart Disease, Autoimmune-Related Fetal Heart Block
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- May 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing An Hospital, Capital Medical University
Beijing, 100011
yihua he, +86 18910778673, yihuaheecho@163.com
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From 16 weeks of gestation to delivery
Secondary outcomes (4)
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.
Measured: 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.
Measured: At delivery
Low Birth Weight
Birth weight less than 2500 grams, as measured at delivery.
Measured: 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.
Measured: From study enrollment until delivery or study withdrawal, whichever came first, assessed up to approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy-Associated Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yihua He,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yihua He,MD, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526662
- Sponsor's protocol ID
- PERI-CARDIO-MF-01
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Dynamic Acquisition of Maternal-Fetal Heart Sound and Electrocardiogram and Early Warning and Risk Stratification of Perinatal Cardiac Adverse Events
- ClinicalTrials.gov ID
- NCT07526662
- Acronym / sponsor ID
- PERI-CARDIO-MF-01
- Conditions
- Pregnancy-Associated Heart Disease, Fetal Congenital Heart Disease, Autoimmune-Related Fetal Heart Block, Perinatal Adverse Events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yihua He,MDUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal Major Adverse Cardiac Events (MACE)
Time frame: 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
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.
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)
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy-Associated Heart Disease and Fetal Congenital Heart Disease, run by Yihua He,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yihua he (+86 18910778673, yihuaheecho@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Major Adverse Cardiac Events (MACE) (time frame: From study enrollment to 6 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.