Informations générales (source: ClinicalTrials.gov)
Computer-assisted Fetal Monitoring - Cardiology (SURFAO-CARDIO)
Interventional
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
août 2020
octobre 2022
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| University Hospital Grenoble Alpes - 38043 - Grenoble - France | Matthias LACHAUD, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- single pregnancy
- between 20 and 26 weeks of amenorrhea
- with a BMI between 18.5 and 30 at the beginning of pregnancy
- fetal heart considered normal after expert ultrasound
- examination conditions deemed correct by the expert
- registered in a social security scheme
- having signed the study consent form
- single pregnancy
- between 20 and 26 weeks of amenorrhea
- with a BMI between 18.5 and 30 at the beginning of pregnancy
- fetal heart considered normal after expert ultrasound
- examination conditions deemed correct by the expert
- registered in a social security scheme
- having signed the study consent form
- subject to a legal protection measure or unable to express consent (guardianship,
guardianship) (article L1121-8)
- deprived of liberty by judicial or administrative decision (article L1121-6)
- in a period of exclusion from another study
- with toxic consumption (i.e. tobacco, alcohol, cannabis)
- Intrauterine growth retardation (estimated fetal weight less than the 10th
percentile)
- fetal heart rhythm disorders
- with unclear pregnancy term
- with pregnancy denial