ObstetricsANSINAONCT07409545
Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes
A study testing Recording of fetal and maternal heart rate in people with Obstetrics, run by University Hospital, Lille.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetrics
- What is being tested?
- Recording of fetal and maternal heart rate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Obstetrics
- Being tested
- Recording of fetal and maternal heart rate
- Keywords
- Electrocardiogram, fECG, patch, heart rate, contractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of fetal and maternal heart rateDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Recording of fetal and maternal heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: At delivery/birth
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.
Measured: At delivery/birth
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.
Measured: 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).
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.
Measured: 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.
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.
Measured: At delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObstetricsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignement
- Masking
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Charles Garabédian, PH, Principal investigator, CHU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409545
- Sponsor's protocol ID
- 2025_0150
- Acronym
- ANSINAO
- Status last verified
- May 2026
- First submitted
- 4 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes
- ClinicalTrials.gov ID
- NCT07409545
- Acronym / sponsor ID
- ANSINAO / 2025_0150
- Conditions
- Obstetrics
- Keywords
- Electrocardiogram, fECG, patch, heart rate, contractions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignement
| Arm | Type | Receives |
|---|---|---|
| TOCONAUTE + ANI RELECTURE | Experimental | Device: Recording of fetal and maternal heart rateThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of fetal and maternal heart rateThis 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 | TOCONAUTE + ANI RELECTURE |
Primary outcome
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.
5 secondary outcomes
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
To evaluate whether the maximum FSI value recorded during the entire recording period can predict neonatal acidosis.
Time frame: At delivery/birth
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Garabédian, PH principal investigator
CHU de Lille
Questions about this trial
What is this clinical trial studying?
A study testing Recording of fetal and maternal heart rate in people with Obstetrics, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Garabédian, PH (03 20 44 59 62 ext. +33, charles.garabedian@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.