Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pregnancy
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Creation of a multimodal databaseMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

To monitor the well-being of a fetus or for clinical diagnosis, the challenge is to extract a high-quality fetal electrocardiogram (fECG) signal from non-invasive sensors on the maternal abdomen. As early as the 20th week of amenorrhea, heart rhythm disorders (tachycardia, bradycardia) can be detect...

To monitor the well-being of a fetus or for clinical diagnosis, the challenge is to extract a high-quality fetal electrocardiogram (fECG) signal from non-invasive sensors on the maternal abdomen. As early as the 20th week of amenorrhea, heart rhythm disorders (tachycardia, bradycardia) can be detected in the fetus, most often by fortuitous circumstance, during routine obstetrical ultrasound examinations. It is then necessary to analyze these rhythmic anomalies, understand their origin and, if necessary, initiate pharmacotherapy. The effectiveness of the treatments is then monitored by ultrasound in the high-risk pregnancy department. The analysis of a fetal electrocardiogram (fECG) provides information that allows to determine the nature of the rhythm disorder, its origin and therefore its potential severity. The innovative methodological approach considered for the extraction of non-invasive ECGf is to combine 2 complementary modalities of the same cardiac phenomenon. This is achieved by combining the use of ECG sensors with sound sensors giving access to phonocardiographic signals (PCG).

Tracking Information

NCT #
NCT04235075
Collaborators
  • TIMC-IMAG
  • University Grenoble Alps
  • Clinical Investigation Centre for Innovative Technology Network
Investigators
Principal Investigator: Matthias LACHUAD, MD University Hospital Grenoble Alpes