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Набор скоро начнётся NCT07526662

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pregnancy-Associated Heart Disease, Fetal Congenital Heart Disease, Autoimmune-Related Fetal Heart Block, Perinatal Adverse Events. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Maternal Major Adverse Cardiac Events (MACE) [Срок оценки: From study enrollment to 6 weeks postpartum]
  • Fetal Congenital Heart Disease (CHD) Progression [Срок оценки: 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) [Срок оценки: From 16 weeks of gestation to delivery]
Вторичные конечные точки (4)
  • Emergency Cesarean Section Due to Cardiac Indications [Срок оценки: From study enrollment until the date of delivery or study withdrawal, whichever came first, assessed up to approximately 34 weeks.]
  • Preterm Birth [Срок оценки: At delivery]
  • Low Birth Weight [Срок оценки: At delivery]
  • Multimodal cardiac signal acquisition feasibility and fetal cardiac acoustic feature characterization [Срок оценки: From study enrollment until delivery or study withdrawal, whichever came first, assessed up to approximately 28 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing An Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07526662 · PERI-CARDIO-MF-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗