Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes

NCT07409545 | Not Yet Recruiting

• 1 other identifier: 2025_0150
• Study Type: interventional
• Target: 760
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obstetrics

Keywords

Electrocardiogram; fECG; patch; heart rate; contractions

Outcome Measures

Primary Outcomes (1)

• 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.

  At delivery/birth

Secondary Outcomes (5)

• 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.

  At delivery/birth

• To evaluate whether the maximum FSI value recorded during the entire recording period can predict neonatal acidosis.

  At delivery/birth

• To evaluate whether the maximum FSI value taken between the epidural and 30 minutes after the epidural can predict neonatal acidosis.

  At delivery/birth

• 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).

  At delivery/birth

• Assess whether the maximum FSI value taken during the different stages of labor (latent phase, second stage, and active phase) can predict neonatal acidosis, defined as an arterial pH < 7.10.

  At delivery/birth

Study Arms (1)

TOCONAUTE + ANI RELECTURE

EXPERIMENTAL

This 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.

Device: Recording of fetal and maternal heart rate

Interventions

Recording of fetal and maternal heart rate DEVICE

This 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.

TOCONAUTE + ANI RELECTURE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Understanding of the French language
• Participant who has given written consent to participate in the study.

You may not qualify if:

• Hospitalization for medical termination of pregnancy
• Death in utero
• Heart transplant
• Twin pregnancy
• Open wound in an area covered or wrapped by the medical device
• Allergy to a component of the TOCONAUTE device: polyamide, polyester, elastane, silver, other synthetic materials
• Sensory disorders rendering the subject insensitive to pain on the skin
• Risk of contamination (viral/infectious) of one of the materials constituting the device
• Participant wearing an implanted medical device (pacemaker, etc.)
• Simultaneous participation in another research study.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Officials

• Charles Garabédian, PH

  CHU de Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Garabédian, PH

CONTACT

03 20 44 59 62; charles.garabedian@chu-lille.fr

Mathilde Herbet

CONTACT

03.62.94.38.19; mathilde.herbet@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignement

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share