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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Device: ECG/PCG and ultrasound signal acquisition

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias LACHAUD, MD; Phone Number: +33 4 76 76 94 95; Email: MLachaud@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • Recruiting
    • University Hospital Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pregnancy volunteer subjects; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject acceptability : Score	The subject acceptability score will be composed by the addition of 7 scales. These scales have been specifically created for the SurFAO system. The score can go from 0 (worst) to 70 (best). Each scale can give from 0 to 10 points to the final score.	10 minutes
Subject Acceptability : Descriptive analysis	Open questions will be asked to the subjects in a questionnaire. A descriptive analysis will be done with the answers.	10 minutes
Use Error evaluation : System Usability Scale (SUS)	The System Usability Scale (SUS) is a validated tool for assessing the subjective usability of a system, in this case, the SurFAO System. It contains 10 questions that are rated on a scale from 1 to 5. "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100." Jeff Sauro established the average score of SUS is 68. The score can go from 0 (worst) to 100 (best).	10 minutes
Use Error evaluation : Descriptive analysis	Difficulties in using the system will be recorded in the case report form and identified using photographs and video. A descriptive analysis will be done.	60 minutes

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Electrocardiogram; Usability; Signal Database; Multimodal signal acquisition
• Other Study ID Numbers: 38RC19.309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No