Computer-assisted Fetal Monitoring - Cardiology

Pregnancy Clinical Trial

— SURFAO-CARDIO  

Official title:

Computer-assisted Fetal Monitoring - Cardiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235075
• Other study ID #: 38RC19.309
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: October 2022

Study information

• Verified date: September 2020
• Source: University Hospital, Grenoble
• Contact: Matthias LACHAUD, MD
• Phone: +33 4 76 76 94 95
• Email: MLachaud[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Grenoble Alpes	Grenoble

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network, TIMC-IMAG, University Grenoble Alps

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:1889-92. doi: 10.1109/EMBC.2014.6943979. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ultrasound signals database	The fetal heart activity is analyzed using mechanograms and Doppler during ultrasound (gold standard).	10 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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