NCT07518550

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026May 2028

Study Start

First participant enrolled

February 12, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 27, 2026

Last Update Submit

April 2, 2026

Conditions

Pregnancy Related

Keywords

pregnancymaternal and fetal electrocardiograms separation2-3 trimesterabdominal ECG signalsartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Signal processing time and computational complexity of the algorithm.

    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).

    Through study completion, an average of 1 year

  • Proportion of rejected or invalid segments where the algorithm failed to reliably extract fetal data.

    Through study completion, an average of 1 year

Study Arms (1)

Electrocardiography registration group

EXPERIMENTAL

Pregnant women in the 2nd to 3rd trimester.

Other: Maternal and fetal electrocardiograms separation

Interventions

Maternal and fetal electrocardiograms separationOTHER

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.

Electrocardiography registration group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • \. Patient's refusal to continue participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 119435, Russia

RECRUITING

Study Officials

  • Philipp Yu Kopylov, Prof.

    I.M. Sechenov First Moscow State Medical University (Sechenov University)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Yu Kopylov, Prof.

CONTACT

+7-903-687-72-64kopylov_f_yu@staff.sechenov.ru

Sheron R Rakhamimova, PhD Student

CONTACT

+7-909-933-54-54rshery2631@yandex.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 8, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

May 30, 2028

Last Updated

April 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)