Obstetrics: Elective Caesarean DeliveryRACHISNANCT07333729
Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
A study testing Recording of fetal and maternal heart rate in people with Obstetrics: Elective Caesarean Delivery, run by University Hospital, Lille at 1 site in France.
Trial summary
Elective cesarean deliveries account for over 10% of births in France and are often scheduled around 39 weeks of gestation. When feasible, spinal anesthesia is considered the gold standard in such a clinical situation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetrics: Elective Caesarean Delivery
- What is being tested?
- Recording of fetal and maternal heart rate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2025to 17 Dec 2026
- 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 scheduled for elective cesarean delivery
- Age: over 18 and under 45 years
- Gestational age ≥ 37 weeks of amenorrhea
- Singleton pregnancy
- Proficient in the French language
- Participant has provided written informed consent to take part in the study
- Affiliated with a national health insurance scheme
Who cannot join
- Requirement for general anesthesia or combined epidural-spinal analgesia
- Fetal malformation
- Intrauterine fetal demise
- Maternal and/or fetal cardiac rhythm disorders
- History of heart transplantation
- Open wound in an area covered or enclosed by one of the study devices
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- Risk of viral or infectious contamination of any component of the device
- Hospitalization for medical termination of pregnancy
- Sensory disorders resulting in lack of pain perception on the skin
- Ongoing treatment that may alter autonomic nervous system activity (e.g., beta-blockers, anticholinergics, atropine)
- Participant with an implanted medical device (e.g., pacemaker)
- Known allergy to any component of the devices: polyamide, polyester, elastane, silver, or other synthetic materials
- Participant whose anatomical area intended for ClearSight sensor placement is insufficient to allow proper application
- Concurrent participation in another interventional research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille, 59037
Charles Garabédian, PH, charles.garabedian@chu-lille.fr
Mathilde Herbet, 03.62.94.38.19, mathilde.herbet@chu-lille.fr
About this study
Official title: Evaluation of the Impact of Spinal Anesthesia on the Fetal Autonomic Nervous System During an Elective Caesarean Delivery
Elective cesarean deliveries account for over 10% of births in France and are often scheduled around 39 weeks of gestation. When feasible, spinal anesthesia is considered the gold standard in such a clinical situation. However, a well-known complication is maternal hypotension, which may lead to placental hypoperfusion and fetal acidosis. Heart rate variability (HRV) markers reflect autonomic nervous system (ANS) activity, which plays a key role in maintaining fetal homeostasis.
The Lille University Hospital has developed a technology to assess parasympathetic activity through HRV analysis. This technology has been adapted to obtain an HRV markers specific of the fetal autonomic nervous system assessment: the Fetal Stress Index (FSI). Preclinical studies have shown that FSI correlates with parasympathetic fluctuations and fetal acidosis.
This pilot study aims to evaluate the impact of spinal anesthesia on fetal ANS activity during elective cesarean delivery using a continuous beat-to-beat fetal heart rate recording device: the TOCONAUTE device. FSI will be retrospectively computed to assess fetal autonomic response. Maternal ANS activity will also be monitored using the Analgesia Nociception Index (ANI). A secondary objective is to explore the predictive value of ANI and FSI for maternal hypotension or fetal hypoxia.
- Conditions
- Obstetrics: Elective Caesarean Delivery
- Being tested
- Recording of fetal and maternal heart rate
- Keywords
- Autonomic nervous system, Spinal anesthesia, Hypotension, Fetal heart rate, TOCONAUTE
- Medical subject headings
- Hypotension
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 Jeanne de Flandre Maternity, Lille University Hospital, specifically in the operating room for cesarean 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). Participants will also be connected to the Analgesia Nociception Index (ANI) monitor and the ClearSight system to collect maternal cardiac output, heart-rate variability (HRV) indices, and continuous blood-pressure data. For each participant, the TOCONAUTE will remain in place on the abdomen for 12 minutes after intrathecal injection. 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 | Not described 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.
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery.
Rate of Fetal Stress Index (FSI) compared with the pre-anesthesia baseline, computed from continuous fetal heart-rate recordings acquired with the TOCONAUTE device.
Measured: At 12 minutes after intrathecal injection
Secondary outcomes (9)
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity at intermediate time points during elective cesarean delivery.
Rate of Fetal Stress Index (FSI) at multiple intermediate time points after intrathecal injection (at placement, at injection (T0) and at T+1, T+3, T+6, and T+9 minutes) compared with the pre-anesthesia baseline, computed from continuous fetal heart-rate recordings acquired with the TOCONAUTE device.
Measured: At placement, at injection, 1 min, 3 min, 6 min and 9 min during elective cesarean delivery.
To evaluate the evolution of maternal blood pressure following spinal anesthesia placement, up to 12 minutes after injection.
Change from baseline in ClearSight® (Edwards Lifesciences®) monitoring parameters (systolic arterial pressure (SAP), mean arterial pressure (MAP) measured at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes, relative to the pre-spinal anesthesia baseline.
Measured: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes,
To evaluate the evolution of cardiac output following spinal anesthesia
Change from baseline in ClearSight® (Edwards Lifesciences®) monitoring parameter: cardiac index (CI) measured relative to the pre-spinal anesthesia baseline.
Measured: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
To evaluate the evolution of cardiac output following spinal anesthesia
Change from baseline in ClearSight® (Edwards Lifesciences®) monitoring parameter: Hypotension Prediction Index (HPI) measured relative to the pre-spinal anesthesia baseline.
Measured: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
Change in ANI measurements measured at placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes, relative to the pre-spinal anesthesia baseline, measured by ANI monitor medical device.
Change in ANI measurements measured relative to the pre-spinal anesthesia baseline.
Measured: At placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.
Rate of FSI (Fetal Stress Index) and HPI (Hypotension Prediction Index) measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes.
Measured: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.
Rate of FSI and ANI measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes.
Measured: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status.
Rate of FSI and HPI measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes, with analyses stratified by the presence or absence of neonatal acidosis (defined as umbilical arterial pH < 7.20 at birth).
Measured: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status.
Rate of FSI and ANI measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes, with analyses stratified by the presence or absence of neonatal acidosis (defined as umbilical arterial pH < 7.20 at birth).
Measured: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start17 Dec 2025
- Primary completion17 Dec 2025
- Study completion17 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetrics: Elective Caesarean DeliveryStudies 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
- Masking
- None (open label)
- Enrolment
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333729
- Sponsor's protocol ID
- 2024_0479
- Acronym
- RACHISNA
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 23 Jan 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Spinal Anesthesia on the Fetal Autonomic Nervous System During an Elective Caesarean Delivery
- ClinicalTrials.gov ID
- NCT07333729
- Acronym / sponsor ID
- RACHISNA / 2024_0479
- Conditions
- Obstetrics: Elective Caesarean Delivery
- Keywords
- Autonomic nervous system, Spinal anesthesia, Hypotension, Fetal heart rate, TOCONAUTE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2026 (estimated)
- First posted
- 12 Jan 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.
Elective cesarean deliveries account for over 10% of births in France and are often scheduled around 39 weeks of gestation. When feasible, spinal anesthesia is considered the gold standard in such a clinical situation. However, a well-known complication is maternal hypotension, which may lead to placental hypoperfusion and fetal acidosis. Heart rate variability (HRV) markers reflect autonomic nervous system (ANS) activity, which plays a key role in maintaining fetal homeostasis.
The Lille University Hospital has developed a technology to assess parasympathetic activity through HRV analysis. This technology has been adapted to obtain an HRV markers specific of the fetal autonomic nervous system assessment: the Fetal Stress Index (FSI). Preclinical studies have shown that FSI correlates with parasympathetic fluctuations and fetal acidosis.
This pilot study aims to evaluate the impact of spinal anesthesia on fetal ANS activity during elective cesarean delivery using a continuous beat-to-beat fetal heart rate recording device: the TOCONAUTE device. FSI will be retrospectively computed to assess fetal autonomic response. Maternal ANS activity will also be monitored using the Analgesia Nociception Index (ANI). A secondary objective is to explore the predictive value of ANI and FSI for maternal hypotension or fetal hypoxia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOCONAUTE + ANI RELECTURE | Experimental | Device: Recording of fetal and maternal heart rate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant woman scheduled for elective cesarean delivery
- Age: over 18 and under 45 years
- Gestational age ≥ 37 weeks of amenorrhea
- Singleton pregnancy
- Proficient in the French language
Key exclusion criteria (14 listed)
- Requirement for general anesthesia or combined epidural-spinal analgesia
- Fetal malformation
- Intrauterine fetal demise
- Maternal and/or fetal cardiac rhythm disorders
- History of heart transplantation
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 Jeanne de Flandre Maternity, Lille University Hospital, specifically in the operating room for cesarean 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). Participants will also be connected to the Analgesia Nociception Index (ANI) monitor and the ClearSight system to collect maternal cardiac output, heart-rate variability (HRV) indices, and continuous blood-pressure data. For each participant, the TOCONAUTE will remain in place on the abdomen for 12 minutes after intrathecal injection. These procedures will not interfere with the standard clinical care provided to the pregnant woman. | Device | TOCONAUTE + ANI RELECTURE |
Primary outcome
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery.
Time frame: At 12 minutes after intrathecal injection
Rate of Fetal Stress Index (FSI) compared with the pre-anesthesia baseline, computed from continuous fetal heart-rate recordings acquired with the TOCONAUTE device.
9 secondary outcomes
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity at intermediate time points during elective cesarean delivery.
Time frame: At placement, at injection, 1 min, 3 min, 6 min and 9 min during elective cesarean delivery.
To evaluate the evolution of maternal blood pressure following spinal anesthesia placement, up to 12 minutes after injection.
Time frame: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes,
To evaluate the evolution of cardiac output following spinal anesthesia
Time frame: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
To evaluate the evolution of cardiac output following spinal anesthesia
Time frame: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
Change in ANI measurements measured at placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes, relative to the pre-spinal anesthesia baseline, measured by ANI monitor medical device.
Time frame: At placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status.
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status.
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
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 23 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recording of fetal and maternal heart rate in people with Obstetrics: Elective Caesarean Delivery, run by University Hospital, Lille at 1 site in France.
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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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, 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?
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery. (time frame: At 12 minutes after intrathecal injection). 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 23 Jan 2026.