Computer-assisted Fetal Monitoring - Cardiology

NCT04235075 | Unknown

• 1 other identifier: 38RC19.309
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Signal Database; Pregnancy; Electrocardiogram; Usability; Multimodal signal acquisition

Outcome Measures

Primary Outcomes (2)

• ECG / PCG Signals database

  Synchronized signals from ECG electrodes and PCG sensors. Signals will be processed to extract fetal ECG and specific waveforms characteristics of fECG (in parts of R waves, P waves, QT intervals, ST intervals).

  20 minutes

• Ultrasound signals database

  The fetal heart activity is analyzed using mechanograms and Doppler during ultrasound (gold standard).

  10 minutes

Secondary Outcomes (4)

• Subject acceptability : Score

  10 minutes

• Subject Acceptability : Descriptive analysis

  10 minutes

• Use Error evaluation : System Usability Scale (SUS)

  10 minutes

• Use Error evaluation : Descriptive analysis

  60 minutes

Study Arms (1)

Pregnancy volunteer subjects

EXPERIMENTAL

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.

Device: ECG/PCG and ultrasound signal acquisition

Interventions

ECG/PCG and ultrasound signal acquisition DEVICE

The ECG - PCG signals are acquired over a 20-minute monitoring phase with passive non invasive sensors (abdominal and thoracic). The volunteer's abdomen is photographed when the electrodes and sensors are installed. An ultrasonography is also performed for 10 minutes. The session is filmed for 5 volunteers accepting the video. Any distinctive elements will be removed from photos and videos to prevent the identification of participants.

Pregnancy volunteer subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• TIMC-IMAG: collaborator
• University Grenoble Alps: collaborator
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (1)

University Hospital Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Related Publications (2)

• Noorzadeh S, Rivet B, Gumery PY. An application of Gaussian processes on ocular artifact removal from EEG. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:554-7. doi: 10.1109/EMBC.2015.7318422.

  PMID: 26736322 BACKGROUND

• Noorzadeh S, Niknazar M, Rivet B, Fontecave-Jallon J, Gumery PY, Jutten C. Modeling quasi-periodic signals by a non-parametric model: application on fetal ECG extraction. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1889-92. doi: 10.1109/EMBC.2014.6943979.

  PMID: 25570347 BACKGROUND

Related Links

• Website of the Clinical Investigation Centre for Innovative Technology of the Grenoble Alpes University Hospital

Study Officials

• Matthias LACHUAD, MD

  University Hospital Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias LACHAUD, MD

CONTACT

+33 4 76 76 94 95; MLachaud@chu-grenoble.fr

Isabelle Boudry, PhD

CONTACT

+33 4 76 76 66 45; IBoudry@chu-grenoble.fr

Study Design

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

Model Details: Creation of a multimodal database

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 21, 2020
• Study Start: August 31, 2020
• Primary Completion: January 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)