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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocardiography registration group | Experimental | Pregnant women in the 2nd to 3rd trimester. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maternal and fetal electrocardiograms separation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation coefficient between automatically extracted fetal heart rates and reference. signals | Сardiotocography (CTG) will be used as a reference. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Signal processing time and computational complexity of the algorithm. | The signal processing time refers to the duration required for the algorithm to analyze and process the input signals, including steps such as filtering, noise removal, feature extraction, and data alignment. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria:
1. Patient's refusal to continue participation in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philipp Yu Kopylov, Prof. | Contact | +7-903-687-72-64 | kopylov_f_yu@staff.sechenov.ru | |
| Sheron R Rakhamimova, PhD Student | Contact | +7-909-933-54-54 | rshery2631@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Yu Kopylov, Prof. | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| V.F. Snegirev Clinic of Obstetrics and Gynecology of I.M. Sechenov First Moscow State Medical University | Recruiting | Moscow | 119435 | Russia |
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| Accuracy of R-peak detection: number of correctly identified fetal heartbeats (sensitivity) and number of false positives (specificity). |
The accuracy of R-peak detection refers to the algorithm's ability to correctly identify fetal heartbeats within the recorded signals. Sensitivity (true positive rate) indicates the proportion of actual fetal heartbeats that were correctly detected by the algorithm. Specificity (true negative rate or false positive rate) reflects the number of false detections, i.e., instances where non-heartbeat signals were incorrectly identified as fetal heartbeats. High sensitivity and specificity are essential for reliable fetal heart rate monitoring, minimizing missed beats and false alarms. |
| Through study completion, an average of 1 year |
| Proportion of rejected or invalid segments where the algorithm failed to reliably extract fetal data. | The proportion of rejected or invalid segments refers to the percentage of data segments in which the algorithm was unable to reliably extract fetal heart rate information. These segments are typically excluded from analysis due to poor signal quality, noise, or other artifacts that prevent accurate detection of fetal data. | Through study completion, an average of 1 year |