Идёт набор NCT07518550

Maternal and Fetal Electrocardiograms Separation Algorithm

Без фазы С лечением Pregnancy Related

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: В протоколе указаны: Maternal and fetal electrocardiograms separation.
Кому может быть актуально: Состояния в реестре: Pregnancy Related. Базовые параметры: 18 лет — 55 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: Россия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Development and Validation of Maternal and Fetal Electrocardiograms (ECG) Separation Algorithm Based on Artificial Intelligence Application

Обзор

Effective monitoring of fetal heart activity during the second and third trimesters remains a vital challenge in perinatal medicine. This study proposes an adaptive algorithm for extracting the fetal electrocardiograms signal from abdominal ECG in pregnant women, considering the physiological characteristics of each trimester. Utilizing modern machine learning methods, independent component analysis, and data from wearable textile electrodes. The goal is to enhance the accuracy and reliability of automatic signal separation. A dataset of 300 recordings will be collected and analyzed. The resulting algorithm will enable rapid and precise detection of fetal heartbeats. To validate the algorithm, 50 patients will be recruited separately.

Подробное описание

Research Objective Development and validation of an algorithm for separating maternal and fetal electrocardiographic signals based on non-invasive abdominal ECG in pregnant women during the second and third trimesters of gestation.

Research Tasks

1. Perform abdominal ECG recordings in pregnant women using a non-invasive technology, ensuring standardized recording conditions and accounting for gestational age. Each recording should contain at least 5-10 minutes of continuous signals, providing sufficient data volume for analysis and algorithm training. 2. Analyze features of abdominal ECG signals at various gestational stages, including morphology of maternal and fetal rhythms, their degree of overlap, and the influence of physiological factors. Compare findings with clinical history and other diagnostic methods. 3. Develop and adapt an algorithm for separating maternal and fetal electrocardiographic signals, considering the specific features during the second and third trimesters, to enhance the accuracy of fetal cardiac activity diagnosis based on machine learning. 4. Evaluate the diagnostic parameters of the algorithm for assessing the fetal condition

Вмешательства

Другое Maternal and fetal electrocardiograms separation
Sensors are attached to the pregnant woman's abdomen on pre-prepared sites, and data are recorded for at least 10 minutes. Afterwards, the ECG signals are processed to remove noise.

Первичные конечные точки

Correlation coefficient between automatically extracted fetal heart rates and reference. signals [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (3)

Signal processing time and computational complexity of the algorithm. [Срок оценки: Through study completion, an average of 1 year]
Accuracy of R-peak detection: number of correctly identified fetal heartbeats (sensitivity) and number of false positives (specificity). [Срок оценки: Through study completion, an average of 1 year]
Proportion of rejected or invalid segments where the algorithm failed to reliably extract fetal data. [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

Age over 18 years
Recordings obtained during the second or third trimester of pregnancy
Recording duration of at least 5 minutes
Singleton pregnancy
Signed informed consent

Критерии исключения

Age under 18 years;
Multiple pregnancy;
Recent medical procedures or interventions that could affect the quality of electrocardiographic data;
Severe maternal conditions (e.g., severe eclampsia, shock, severe organ failure, etc.);
Severe fetal conditions (e.g., significant hypoxia, severe placental-fetal syndrome, and other life-threatening states).