Perinatal asphyxia affects 3 to 8 newborns per 1,000 births, with moderate or severe anoxic-ischemic encephalopathy occurring in 0.5 to 1 per 1,000 births. Approximately 15 to 20% of affected newborns will die during the postnatal period, and 25 to 50% of those who survive will develop severe disabilities (epilepsy, cerebral palsy, sensory, behavioral, and psychiatric disorders).
In situations where there is a risk of perinatal asphyxia, the challenge for obstetricians is to choose between vaginal delivery or cesarean section and to determine the optimal time to induce labor in order to prevent brain damage.
Visual analysis of fetal heart rate (FHR) and uterine contraction signals by cardiotocography (CTG) is the gold standard method for monitoring fetal status and is one of the most common obstetric procedures. Numerous classifications have been proposed to classify FHR and predict neonatal outcomes. Unfortunately, they have a high rate of interobserver variability and low specificity for predicting neonatal complications.
The INSERM CIC-IT 1403 unit at Lille University Hospital has previously developed an innovative heart rate variability (HRV) analysis method for assessing autonomic nervous system activity. This technology has been adapted for assessing pain and well-being in adults and newborns (ANI and NIPE® monitors) and is now distributed in more than 70 countries worldwide. Numerous studies have demonstrated the ability of this HRV analysis to study the autonomic response to painful stimuli in adults, children, and newborns. More recently, we have studied the ability of our HRV analysis method to predict acidosis and have adapted it to obtain a fetal stress index (FSI).
As proof of concept for the effectiveness of FSI in treating acidosis and adverse neonatal outcomes (i.e., brain damage) has been established in an animal model as part of the PrevAP project, we hypothesize that FSI analysis could provide an effective means of assessing acidosis in human fetuses. Such real-time analysis of fetal HRV is now possible thanks to the TOCONAUTE system, whose safety and performance have been demonstrated in a previous study.
Pregnant woman admitted to the delivery room for childbirth
Fetus in cephalic presentation
Aged 18 to 45 years old
Gestational age greater than 37 weeks
Hospitalization for medical termination of pregnancy
Death in utero
Heart transplant
Twin pregnancy
Single group
Recording of fetal and maternal heart rate
DeviceThis study will be conducted in the maternity ward of the Lille's Jeanne de Flandre Hospital, Poissy's Hospital and Nantes University Hospital and during delivery, specifically in the operating room for delivery. The TOCONAUTE device will be placed on the mother's abdomen to record fetal heart rate. Recordings will be analyzed retrospectively using the ANI RELECTURE software to calculate the Fetal Stress Index (FSI). For each participant, the TOCONAUTE will remain in place on the abdomen. These procedures will not interfere with the standard clinical care provided to the pregnant woman.
Demonstrate the ability of the maximum FSI value taken one hour before birth to predict neonatal acidosis and determine its optimal prediction threshold.
Area under the Receiver Operating Characteristic (ROC) curve of the maximum FSI value taken one hour before birth to differentiate between newborns with and without neonatal acidosis defined by an umbilical arterial pH \< 7.10.
To evaluate whether the maximum FSI value taken in the 30 minutes prior to the onset of expulsive labor (or prior to the decision to perform a cesarean section) can predict neonatal acidosis.
Area under the ROC curve of the maximum FSI value taken in the 30 minutes preceding the onset of expulsive efforts (or before the decision to initiate a cesarean section) to differentiate between newborns with and without neonatal acidosis defined by an umbilical arterial pH \< 7.10).
To evaluate whether the maximum FSI value recorded during the entire recording period can predict neonatal acidosis.
Area under the ROC curve of the maximum FSI value taken throughout the recording period to differentiate between newborns with and without neonatal acidosis defined by an umbilical arterial pH \< 7.10.
To evaluate whether the maximum FSI value taken between the epidural and 30 minutes after the epidural can predict neonatal acidosis.
Area under the ROC curve of the maximum FSI value taken between the epidural and 30 minutes after the epidural to differentiate between newborns with and without neonatal acidosis defined by an umbilical arterial pH \< 7.10.
To evaluate whether the maximum FSI value taken in the 30 minutes preceding the scalp pH can predict intrapartum acidosis (defined as a scalp pH < 7.20).
Area under the ROC curve of the maximum FSI value in the 30 minutes preceding scalp pH to differentiate between newborns with and without intrapartum acidosis defined by a scalp pH \< 7.20.
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University Hospital, Lille
Lead sponsor
Clinical Investigation Centre for Innovative Technology Network
Collaborator
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