ECG-PCG-CTG Acquisition on Pregnant Voluntary SubjectsSURFAO-ObstNCT03857126
Computer-assisted Fetal Monitoring - Obstetrics
An observational study of ECG-PCG-CTG Acquisition on Pregnant Voluntary Subjects, run by University Hospital, Grenoble at 1 site in France.
Trial summary
In the context of fetal heart monitoring, the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from few 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))… 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
- ECG-PCG-CTG Acquisition on Pregnant Voluntary Subjects
- What is being tested?
- Signal acquisition
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 31 May 2021
- Phase
- Observational
- 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
Study population: Pregnant women
Who may be able to join
- Pregnant of a single pregnancy,
- Aged over 18,
- During the 9th month of pregnancy (>= 37 weeks),
- With uncomplicated maternal and fetal pregnancy follow-up,
- With a BMI between 18.5 and 30 at the beginning of pregnancy,
- Without a notable medical history,
- Enrolled in a social security scheme,
- Having signed the consent form for the study.
Who cannot join
- Subject under guardianship, protected by law or deprived of liberty (Article L1121-8),
- Subject under administrative or judicial supervision,
- Subject in exclusion period of another study,
- With toxic consumption (i.e. tobacco, alcohol, cannabis),
- With inaccurate pregnancy term,
- With denial of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surveillance fœtale assistée Par Ordinateur - Obstétrique
In the context of fetal heart monitoring, the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from few 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 proposed 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 (phonocardiographic)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need for the monitoring process support, and by setting up a reference for this multimodal database.
The objective is to feed a database that will be used in the future to develop ECGf extraction methods estimating the FHR.
Read the detailed description
To monitor the well-being of a fetus or for a clinical diagnosis, a challenge is to extract a fetal electrocardiogram (fECG) signal of high quality from a limited number of non-invasive sensors on the maternal abdomen.
During childbirth, fetal monitoring is assessed by the fetal heart rate (FHR), classically from cardiotocography (CTG). The aim is to monitor FHR variability anomalies that reflect a too high fetal malaise. It is very common to have difficulties to reliably record FHR due to confusion of rhythms of the mother and the fetus that can lead to unnecessary caesareans. With 800000 childbirths in France per year, improving the reliability of FHR estimation by fECG analysis is therefore of high clinicalinterest.
To deal with, the proposed approach aims at coupling two complementary cardiac information acquired at the best-located position. Therefore, the proposed solution is (i) to combine the use of electrophysiological sensors ECG and acoustic sensors of microphonic type that can register phonocardiographic signals (PCG), (ii) to assist by computer the clinical expertise to choose the best sensors location. Several methodological aspects will be considered: to improve the robustness of the FHR estimation with degraded signals based on multimodality, to overcome some practical limitations to extract the fECG waveforms by enhancing the process extraction with PCG and to assist the user in the sensors choice and placement by predicting their best locations and their kinds (ECG or PCG).
The SurFAO project proposes then an original approach of computer-assisted fetal monitoring and thus differs from previous published works of fECG extraction solutions, only based on algorithmic performances mostly in well-controlled situations. The original aspects of the investigator's proposal are the innovative methodological choices based on multimodality and informed recording process, the consideration of the medical uses and of the necessity to help the clinical monitoring to design the algorithms, the new reference multimodal database, and the academic-clinical consortium, that will guarantee the relevance of all proposed parts.
- Being tested
- Signal acquisition
- Keywords
- Signal Database, Pregnancy, Electrocardiogram, Phonocardiogram, Cardiotocography, Usability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal acquisitionOther
Also called Non invasive ECG-PCG-CTG sensors
ECG-PCG-CTG synchronized signals acquisition over a monitoring phase of 30 minutes. These signals will be acquired with passive non invasive sensors (abdominal and thoracic).
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy volunteer subjects | Subjects who will agree to participate in the investigator's study will be pregnant healthy subjects with no particular antecedent, followed at the University Hospital of Grenoble for a physiological pregnancy; their child will be not affected by any prenatal pathology.
Subjects will be enrolled in a 30 min monitoring phase to collect signals from ECG-PCG-CTG abdominal and thoracic non invasive sensors. Receives: Other: Signal acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG Signals Database
Synchronized signals from ECG electrodes during a 30-minute monitoring phase. Tracking of the electrical activity in the heart. During the study period we will collect R wave, P wave, QT interval, ST interval, QRS complex, RR interval components of the ECG.
Signals were then processed to extract fetal ECG.
Measured: 30 minutes
PCG Signals Database
Synchronized signals from PCG sensors during a 30-minute monitoring phase. Acquisition of acoustic information reflecting the contraction and relaxation of the heart.
During the study period we will collect S1 and S2 sounds components of the PCG. Signals were then processed to extract fetal PCG.
Measured: 30 minutes
CTG Signals Database
CTG is continuous monitoring of the fetal heart rate (gold standard reference). Physicians evaluate specific clinical CTG parameters by means of visual inspection.
Measured: 30 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: 15 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: 15 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: 15 minutes
Use Error evaluation : Descriptive analysis
In a journal, the users will write their difficulties using the system. A descriptive analysis will be done with the answers.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start2 May 2019
- Primary completion15 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ECG-PCG-CTG Acquisition on Pregnant Voluntary SubjectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
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
- Véronique Equy, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857126
- Sponsor's protocol ID
- 38RC18.172
- Acronym
- SURFAO-Obst
- Status last verified
- Jun 2021
- First submitted
- 31 Dec 2018
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Equy V, Buisson S, Heinen M, Schaal J-P, Hoffmann P, Sergent F. Confusion between maternal and fetal heart rate during delivery: risk factors and consequences British Journal of Midwifery, vol.20 (11), 2012
Gobillot S, Fontecave-Jallon J, Equy V, Rivet B, Gumery PY, Hoffmann P. Non-invasive fetal monitoring using electrocardiography and phonocardiography: A preliminary study. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):455-459. doi: 10.1016/j.jogoh.2018.08.009. Epub 2018 Aug 23.
PubMed 30144558Noorzadeh 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 25570347Noorzadeh S, Rivet B, Guméry PY. A multi-modal approach using a non-parametric model to extract fetal ECG. Proc. IEEE Int. Conf. Acoustics, Speech, and Signal Processing (ICASSP), Brisbane, Australia, 2015, pp. 1856-60
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance fœtale assistée Par Ordinateur - Obstétrique
- ClinicalTrials.gov ID
- NCT03857126
- Acronym / sponsor ID
- SURFAO-Obst / 38RC18.172
- Keywords
- Signal Database, Pregnancy, Electrocardiogram, Phonocardiogram, Cardiotocography, Usability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG, University Grenoble Alps, Clinical Investigation Centre for Innovative Technology Network
- Study start
- 2 May 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 27 Feb 2019 (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, the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from few 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 proposed 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 (phonocardiographic)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need for the monitoring process support, and by setting up a reference for this multimodal database.
The objective is to feed a database that will be used in the future to develop ECGf extraction methods estimating the FHR.
Detailed description
To monitor the well-being of a fetus or for a clinical diagnosis, a challenge is to extract a fetal electrocardiogram (fECG) signal of high quality from a limited number of non-invasive sensors on the maternal abdomen.
During childbirth, fetal monitoring is assessed by the fetal heart rate (FHR), classically from cardiotocography (CTG). The aim is to monitor FHR variability anomalies that reflect a too high fetal malaise. It is very common to have difficulties to reliably record FHR due to confusion of rhythms of the mother and the fetus that can lead to unnecessary caesareans. With 800000 childbirths in France per year, improving the reliability of FHR estimation by fECG analysis is therefore of high clinicalinterest.
To deal with, the proposed approach aims at coupling two complementary cardiac information acquired at the best-located position. Therefore, the proposed solution is (i) to combine the use of electrophysiological sensors ECG and acoustic sensors of microphonic type that can register phonocardiographic signals (PCG), (ii) to assist by computer the clinical expertise to choose the best sensors location. Several methodological aspects will be considered: to improve the robustness of the FHR estimation with degraded signals based on multimodality, to overcome some practical limitations to extract the fECG waveforms by enhancing the process extraction with PCG and to assist the user in the sensors choice and placement by predicting their best locations and their kinds (ECG or PCG).
The SurFAO project proposes then an original approach of computer-assisted fetal monitoring and thus differs from previous published works of fECG extraction solutions, only based on algorithmic performances mostly in well-controlled situations. The original aspects of the investigator's proposal are the innovative methodological choices based on multimodality and informed recording process, the consideration of the medical uses and of the necessity to help the clinical monitoring to design the algorithms, the new reference multimodal database, and the academic-clinical consortium, that will guarantee the relevance of all proposed parts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy volunteer subjects | – | Other: Signal acquisitionSubjects who will agree to participate in the investigator's study will be pregnant healthy subjects with no particular antecedent, followed at the University Hospital of Grenoble for a physiological pregnancy; their child will be not affected by any prenatal pathology. Subjects will be enrolled in a 30 min monitoring phase to collect signals from ECG-PCG-CTG abdominal and thoracic non invasive sensors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (8 listed)
- Pregnant of a single pregnancy,
- Aged over 18,
- During the 9th month of pregnancy (>= 37 weeks),
- With uncomplicated maternal and fetal pregnancy follow-up,
- With a BMI between 18.5 and 30 at the beginning of pregnancy,
Key exclusion criteria (6 listed)
- Subject under guardianship, protected by law or deprived of liberty (Article L1121-8),
- Subject under administrative or judicial supervision,
- Subject in exclusion period of another study,
- With toxic consumption (i.e. tobacco, alcohol, cannabis),
- With inaccurate pregnancy term,
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 |
|---|---|---|
| Signal acquisitionAlso: Non invasive ECG-PCG-CTG sensorsECG-PCG-CTG synchronized signals acquisition over a monitoring phase of 30 minutes. These signals will be acquired with passive non invasive sensors (abdominal and thoracic). | Other | Pregnancy volunteer subjects |
Primary outcome
ECG Signals Database
Time frame: 30 minutes
Synchronized signals from ECG electrodes during a 30-minute monitoring phase. Tracking of the electrical activity in the heart. During the study period we will collect R wave, P wave, QT interval, ST interval, QRS complex, RR interval components of the ECG. Signals were then processed to extract fetal ECG.
PCG Signals Database
Time frame: 30 minutes
Synchronized signals from PCG sensors during a 30-minute monitoring phase. Acquisition of acoustic information reflecting the contraction and relaxation of the heart. During the study period we will collect S1 and S2 sounds components of the PCG. Signals were then processed to extract fetal PCG.
CTG Signals Database
Time frame: 30 minutes
CTG is continuous monitoring of the fetal heart rate (gold standard reference). Physicians evaluate specific clinical CTG parameters by means of visual inspection.
4 secondary outcomes
Subject Acceptability: Score
Time frame: 15 minutes
Subject Acceptability : Descriptive analysis
Time frame: 15 minutes
Use Error evaluation : System Usability Scale (SUS)
Time frame: 15 minutes
Use Error evaluation : Descriptive analysis
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Results publicationEquy V, Buisson S, Heinen M, Schaal J-P, Hoffmann P, Sergent F. Confusion between maternal and fetal heart rate during delivery: risk factors and consequences British Journal of Midwifery, vol.20 (11), 2012
- Results publication: PubMed 30144558Gobillot S, Fontecave-Jallon J, Equy V, Rivet B, Gumery PY, Hoffmann P. Non-invasive fetal monitoring using electrocardiography and phonocardiography: A preliminary study. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):455-459. doi: 10.1016/j.jogoh.2018.08.009. Epub 2018 Aug 23.
- Results publication: 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.
- Results publication: 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.
- Results publicationNoorzadeh S, Rivet B, Guméry PY. A multi-modal approach using a non-parametric model to extract fetal ECG. Proc. IEEE Int. Conf. Acoustics, Speech, and Signal Processing (ICASSP), Brisbane, Australia, 2015, pp. 1856-60
- Individual participant dataSharing planned: No
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.
Véronique Equy principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ECG-PCG-CTG Acquisition on Pregnant Voluntary Subjects, 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 4 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG Signals Database (time frame: 30 minutes). The study lists 3 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 NCT03857126, which also lists 5 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 4 Jun 2021.