Separating maternal and fetal heart signals from abdominal ECG

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect at least 300 abdominal ECG recordings using wearable textile electrodes from women in their second and third trimesters, with each recording lasting 5–10 minutes under standardized conditions. Signal features will be analyzed by gestational stage and compared with clinical information to characterize maternal and fetal rhythm overlap. Machine learning methods and independent component analysis will be used to develop an adaptive algorithm tuned for trimester-specific physiology, followed by validation on a separate cohort of 50 patients. The goal is to improve the accuracy and reliability of automatic fetal heartbeat detection from noninvasive abdominal recordings.

Why it matters

Who can join: the full rules

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.

Where it's running

• V.F. Snegirev Clinic of Obstetrics and Gynecology of I.M. Sechenov First Moscow State Medical University
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Philipp Yu Kopylov, Prof. — I.M. Sechenov First Moscow State Medical University (Sechenov University)
• Study coordinator: Philipp Yu Kopylov, Prof.
• Email: kopylov_f_yu@staff.sechenov.ru
• Phone: +7-903-687-72-64

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.