Computer-assisted Fetal Monitoring - Obstetrics

NCT ID: NCT03857126

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-02
• Study Completion Date: 2021-05-31

Brief 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)) 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.

Conditions

ECG-PCG-CTG Acquisition on Pregnant Voluntary Subjects

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Signal acquisition

Intervention Type: OTHER

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).

Interventions

Signal acquisition

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).

Intervention Type: OTHER

Other Intervention Names

Non invasive ECG-PCG-CTG sensors

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TIMC-IMAG

OTHER

Sponsor Role: collaborator

University Grenoble Alps

OTHER

Sponsor Role: collaborator

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Véronique Equy

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

University Hospital Grenoble

Grenoble, , France

Countries

France

References

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

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 30144558 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26736322 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25570347 (View on PubMed)

Noorzadeh 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

Reference Type: RESULT

Other Identifiers

38RC18.172

Identifier Type: -

Identifier Source: org_study_id