CE19 - Technologies pour la santé

Prevention of Perinatal Asphyxia – PrevAP

Submission summary

Perinatal asphyxia can occur during pregnancy, labor and delivery and presents some risks of Hypoxic-Ischemic Encephalopathy or long term neurologic morbidity. Low umbilical pH (acidosis) at birth is used worldwide as a biomarker of the severity of perinatal asphyxia.
In at-risk cases of perinatal asphyxia, the challenge for obstetricians is to determine the best timing to induce birth and guide the decision between a vaginal delivery or a Caesarean section in order to prevent brain damage.
In current practice, the analysis of fetal heart rate measured by cardiotocography represents the first line monitoring tool during labor and delivery. Second line monitoring systems are based on more invasive tools, such as fetal scalp blood sampling or the analysis of the ST-segment of the fetal electrocardiogram. Despite extensive use of these current monitoring methods, no significant reduction in the incidence of hypoxic ischemic encephalopathy (HEI) and related long-term neurologic morbidity has been reported. Furthermore, their use has been associated with an increase in Caesarean sections.
Because of the well-known limits of the technologies cited above and the invasiveness of the second line tools, a more sensitive continuous and non-invasive method of fetal monitoring is needed.
The INSERM CIC-IT 1403 team has designed a cutting edge technology for fetal heart rate variability analysis. Our preliminary experimental studies provide evidences that this method overcomes the main limitations of the current methods of fetal heart rate analysis and meets the specifications for a reliable biomarker for early identification of fetal hypoxia.
Following this proof of concept, the objectives of the project are:
• The improvement of fetal heart rate recording quality to be able to extract continuously assess fetal heart rate variability with efficiency required to obtain a non invasive reliable biomarker predictive of perinatal asphyxia;
• The development, validation and certification of a new medical device which will provide clinicians with the new biomarker and all the current variables of fetal monitoring (FHR, uterine contractions, maternal heart rate) with a higher accuracy.
In this project, the technological development and experimental/clinical studies will be conducted jointly to overcome the technical, scientific, medical and ergonomic barriers required to implement our fetal heart rate variability analysis as a new biomarker of fetal hypoxia.

Project coordinator

Monsieur Julien De Jonckheere (CIC-IT 1403 - Biocapteurs et e-santé)

The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.

Partner

EA4489 EA 4489 - Environement périntatal et santé
CIC-IT CIC-IT 1403 - Biocapteurs et e-santé
Bioserenity BIOSERENITY

Help of the ANR 435,706 euros
Beginning and duration of the scientific project: - 36 Months

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