NCT07518550 Maternal and Fetal Electrocardiograms Separation Algorithm
| NCT ID | NCT07518550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.M. Sechenov First Moscow State Medical University |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-02-12 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2026-02-12 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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). Exclusion criteria: 1\. Patient's refusal to continue participation in the study.
Contact & Investigator
Philipp Yu Kopylov, Prof.
PRINCIPAL INVESTIGATOR
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Frequently Asked Questions
Who can join the NCT07518550 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07518550 currently recruiting?
Yes, NCT07518550 is actively recruiting participants. Contact the research team at kopylov_f_yu@staff.sechenov.ru for enrollment information.
Where is the NCT07518550 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07518550 clinical trial?
NCT07518550 is sponsored by I.M. Sechenov First Moscow State Medical University. The principal investigator is Philipp Yu Kopylov, Prof. at I.M. Sechenov First Moscow State Medical University (Sechenov University). The trial plans to enroll 350 participants.