Computer-assisted Fetal Monitoring - Obstetrics

NCT03857126 | Completed

• 1 other identifier: 38RC18.172
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ECG-PCG-CTG Acquisition on Pregnant Voluntary Subjects

Keywords

Signal Database; Pregnancy; Electrocardiogram; Phonocardiogram; Cardiotocography; Usability

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  30 minutes

Secondary Outcomes (4)

• Subject Acceptability: Score

  15 minutes

• Subject Acceptability : Descriptive analysis

  15 minutes

• Use Error evaluation : System Usability Scale (SUS)

  15 minutes

• Use Error evaluation : Descriptive analysis

  15 minutes

Study Arms (1)

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.

Other: Signal acquisition

Interventions

Signal acquisition 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).

Also known as: Non invasive ECG-PCG-CTG sensors

Pregnancy volunteer subjects

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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.

You may not qualify if:

• Subject under guardianship, protected by law or deprived of liberty (Article L1121-8),
• Subject under administrative or judicial supervision,
• With toxic consumption (i.e. tobacco, alcohol, cannabis),
• With inaccurate pregnancy term,
• With denial of pregnancy.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• TIMC-IMAG: collaborator
• University Grenoble Alps: collaborator
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (5)

• 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

  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.

  PMID: 30144558 RESULT

• 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.

  PMID: 26736322 RESULT

• 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.

  PMID: 25570347 RESULT

• 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

  RESULT

Study Officials

• Véronique Equy

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: February 27, 2019
• Study Start: May 2, 2019
• Primary Completion: April 15, 2021
• Study Completion: May 31, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)