Prevention of Perinatal Asphyxia – PrevAP

Form a technical point of view, the objectives of the project are:
• The adaptation of the heart rate variability method for apshyxia prediction in human fetuses.
• Conception of a medical device for efficient and non invasive fetal heart rate monitoring
• Clinical validation of the medical device.

2 precilinical studies were performed ;
The first one aimed to record different physiological transabdominal signals in order to obtain a signal database to develop the heart beat detection signal processing algorithm. This records were performed using a device developped by the CIC-IT. We included 50 pregnant patients. The signal database allowed to develop an efficient algorithme for heart beat detection and uterine contraction monitoring.
The second study aimed to analyse the link between our biomarker and asphyxia and brain damage. We performed 14 experimentations in a fetal sheep model. We demonstarted as strong link between our biomarker, perinatal asphyxia and brain damage.

We developped a first operational prototype. A final ore-industrial version of the device will be develop in 2020 in order to perform a multicentric clinical study to validate the biomarker in a huge population.

1. SMFM conference , Las Vegas, Nevada, US, 2019
2. SMFM onférence, Grapevine, Texas, US, 2020
3. IEEE EMBC 2019, Berlin, Germany, 2019

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.