PregnancySURFAO-CARDIONCT04235075
Computer-assisted Fetal Monitoring - Cardiology
A study testing ECG/PCG and ultrasound signal acquisition in people with Pregnancy, run by University Hospital, Grenoble at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- ECG/PCG and ultrasound signal acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2020to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble Alpes
Grenoble, 38043
Matthias LACHAUD, MD
Isabelle Boudry, PhD, +33 4 76 76 66 45, IBoudry@chu-grenoble.fr
About this study
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.
Read the 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).
- Conditions
- Pregnancy
- Being tested
- ECG/PCG and ultrasound signal acquisition
- Keywords
- Signal Database, Pregnancy, Electrocardiogram, Usability, Multimodal signal acquisition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG/PCG and ultrasound signal acquisitionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ECG/PCG and ultrasound signal acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 minutes
Ultrasound signals database
The fetal heart activity is analyzed using mechanograms and Doppler during ultrasound (gold standard).
Measured: 10 minutes
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start31 Aug 2020
- Primary completionJan 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Creation of a multimodal database
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, University Grenoble Alps, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Matthias LACHUAD, MD, Principal investigator, University Hospital Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235075
- Sponsor's protocol ID
- 38RC19.309
- Acronym
- SURFAO-CARDIO
- Status last verified
- Sep 2020
- First submitted
- 7 Jan 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26736322Noorzadeh 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.
PubMed 25570347
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Fetal Monitoring - Cardiology
- ClinicalTrials.gov ID
- NCT04235075
- Acronym / sponsor ID
- SURFAO-CARDIO / 38RC19.309
- Conditions
- Pregnancy
- Keywords
- Signal Database, Pregnancy, Electrocardiogram, Usability, Multimodal signal acquisition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG, University Grenoble Alps, Clinical Investigation Centre for Innovative Technology Network
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Creation of a multimodal database
| Arm | Type | Receives |
|---|---|---|
| Pregnancy volunteer subjects | Experimental | Device: ECG/PCG and ultrasound signal acquisitionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG/PCG and ultrasound signal acquisitionThe 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. | Device | Pregnancy volunteer subjects |
Primary outcome
ECG / PCG Signals database
Time frame: 20 minutes
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).
Ultrasound signals database
Time frame: 10 minutes
The fetal heart activity is analyzed using mechanograms and Doppler during ultrasound (gold standard).
4 secondary outcomes
Subject acceptability : Score
Time frame: 10 minutes
Subject Acceptability : Descriptive analysis
Time frame: 10 minutes
Use Error evaluation : System Usability Scale (SUS)
Time frame: 10 minutes
Use Error evaluation : Descriptive analysis
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Background: PubMed 26736322Noorzadeh 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.
- Background: PubMed 25570347Noorzadeh 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.
- Website of the Clinical Investigation Centre for Innovative Technology of the Grenoble Alpes University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias LACHUAD, MD principal investigator
University Hospital Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG/PCG and ultrasound signal acquisition in people with Pregnancy, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias LACHAUD, MD (+33 4 76 76 94 95, MLachaud@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG / PCG Signals database (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235075, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.