Computer-assisted Fetal Monitoring - Cardiology (SURFAO-CARDIO)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Pregnancy

Treatments: Device: ECG/PCG and ultrasound signal acquisition

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04235075

38RC19.309

Details and patient eligibility

About

In the context of fetal heart monitoring (prenatal and during childbirth), the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from non-invasive sensors on the maternal abdomen, a fetal electrocardiogram (ECGf) of great quality allowing a clinical diagnosis (follow-up of the FHR (Fetal Heart Rate)) and extraction of ECG waveforms).

The approach proposes a technological breakthrough shared by a consortium of researchers and clinicians. The originality is driven by innovative methodological choices: the use of a multimodal system (ECG coupling with PCG (phonocardiography)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need to support the monitoring process, and by setting up a multimodal database.

The objective is to feed a database that will be used in the future to develop ECGf extraction methods.

Full 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 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).

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• single pregnancy
• between 20 and 26 weeks of amenorrhea
• with a BMI between 18.5 and 30 at the beginning of pregnancy
• fetal heart considered normal after expert ultrasound
• examination conditions deemed correct by the expert
• registered in a social security scheme
• having signed the study consent form

Exclusion criteria

• subject to a legal protection measure or unable to express consent (guardianship, guardianship) (article L1121-8)
• deprived of liberty by judicial or administrative decision (article L1121-6)
• in a period of exclusion from another study
• with toxic consumption (i.e. tobacco, alcohol, cannabis)
• Intrauterine growth retardation (estimated fetal weight less than the 10th percentile)
• fetal heart rhythm disorders
• with unclear pregnancy term
• with pregnancy denial

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Pregnancy volunteer subjects

Experimental group

Description:

Subjects who will agree to participate in the study will be pregnant women referred to the Grenoble Alpes University Hospital for expert fetal cardiac ultrasound examination who have not revealed any abnormalities.

Treatment:

Device: ECG/PCG and ultrasound signal acquisition