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Computer-assisted Fetal Monitoring - Cardiology

NCT04235075 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-23

No results posted yet for this study

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 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.

Conditions

  • Pregnancy

Interventions

DEVICE

ECG/PCG and ultrasound signal acquisition

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.

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

  • Matthias LACHUAD, MD · University Hospital Grenoble Alpes

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2022-01-31
Completion
2022-10-31

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 NCT04235075 on ClinicalTrials.gov