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Clinical Trial NCT07333729 (RACHISNA) for Obstetrics: Elective Caesarean Delivery is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System (RACHISNA) 50

Recruiting
Clinical Trial NCT07333729 (RACHISNA) is an interventional study for Obstetrics: Elective Caesarean Delivery that is recruiting. It started on 17 December 2025 with plans to enroll 50 participants. Led by University Hospital, Lille, it is expected to complete by 17 December 2026. The latest data from ClinicalTrials.gov was last updated on 23 January 2026.
Brief 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. 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) act...Show More
Official Title

Evaluation of the Impact of Spinal Anesthesia on the Fetal Autonomic Nervous System During an Elective Caesarean Delivery

Conditions
Obstetrics: Elective Caesarean Delivery
Other Study IDs
  • RACHISNA
  • 2024_0479
NCT ID Number
NCT07333729
Start Date (Actual)
2025-12-17
Last Update Posted
2026-01-23
Completion Date (Estimated)
2026-12-17
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Autonomic nervous system
Spinal anesthesia
Hypotension
Fetal heart rate
TOCONAUTE
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTOCONAUTE + ANI RELECTURE
Recording of fetal and maternal heart rate
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 t...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
At 12 minutes after intrathecal injection
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
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.
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.
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.
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.
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.
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).
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).
At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • 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
  • 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
University Hospital, Lille logoUniversity Hospital, Lille
Clinical Investigation Centre for Innovative Technology Network logoClinical Investigation Centre for Innovative Technology Network
Study Central Contact
Contact: Charles Garabédian, PH, 03 20 44 59 62, [email protected]
Contact: Mathilde Herbet, 03.62.94.38.19, [email protected]
1 Study Locations in 1 Countries
CHU de Lille, Lille, 59037, France
Charles Garabédian, PH, Contact, [email protected]
Mathilde Herbet, Contact, 03.62.94.38.19, [email protected]
Recruiting