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NCT Number: NCT07409545

Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes

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.

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Key information

Conditions

Obstetrics

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The aim of the project is to include a cohort of pregnant women from the onset of labor until delivery. The database will include multiple physiological signals provided by TOCONAUTE (fetal electrocardiogram (ECG), maternal ECG, uterine contractions, FHR, maternal heart rate signal, etc.), blood sample analyses (pH, lactate, base excess, pO2, pCO2, etc.), and maternal and neonatal outcomes. The objective is to confirm the FSI's ability to predict neonatal acidosis in human fetuses and to determine the optimal FSI threshold for predicting neonatal acidosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

    Time frame: At delivery/birth

    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.

Secondary outcomes

  1. 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.

    Time frame: At delivery/birth

    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).

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

    Time frame: At delivery/birth

    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.

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

    Time frame: At delivery/birth

    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.

  4. 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).

    Time frame: At delivery/birth

    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.

  5. 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.

    Time frame: At delivery/birth

    Area under the ROC curve of the maximum FSI value during the different stages of labor (latent phase, second stage, and active phase). To differentiate between newborns with and without neonatal acidosis defined by an umbilical arterial pH < 7.10.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Garabédian, PH

CONTACT

[email protected]

03 20 44 59 62 ext. +33

Mathilde Herbet

CONTACT

[email protected]

03.62.94.38.19 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

Registry information

Acronym: ANSINAO

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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