Computer-assisted Fetal Monitoring - Obstetrics

NCT03857126 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-06-04

No results posted yet for this study

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

Interventions

OTHER

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).

Sponsors & Collaborators

  • TIMC-IMAG

    collaborator OTHER
  • University Grenoble Alps

    collaborator OTHER
  • Clinical Investigation Centre for Innovative Technology Network

    collaborator NETWORK
  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Véronique Equy · CHU Grenoble Alpes

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2021-04-15
Completion
2021-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857126 on ClinicalTrials.gov