Actively Recruiting
Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
Led by University Hospital, Lille · Updated on 2026-01-23
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
C
Clinical Investigation Centre for Innovative Technology Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant woman scheduled for elective cesarean delivery
- Age over 18 and under 45 years
- Gestational age at least 37 weeks of amenorrhea
- Singleton pregnancy
- Proficient in the French language
- Provided written informed consent to participate
- Affiliated with a national health insurance scheme
You will not qualify if you...
- Need for general anesthesia or combined epidural-spinal analgesia
- Presence of fetal malformation
- Intrauterine fetal demise
- Maternal or fetal cardiac rhythm disorders
- History of heart transplantation
- Open wound in area covered by study devices
- Risk of viral or infectious contamination of device components
- Hospitalization for medical termination of pregnancy
- Sensory disorders causing lack of skin pain perception
- Ongoing treatment affecting autonomic nervous system (e.g., beta-blockers, anticholinergics, atropine)
- Presence of implanted medical device (e.g., pacemaker)
- Known allergy to components of devices (polyamide, polyester, elastane, silver, or other synthetics)
- Insufficient anatomical area for ClearSight sensor placement
- Participation in another interventional research study
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Lille
Lille, France, 59037
Actively Recruiting
Research Team
C
Charles Garabédian, PH
CONTACT
M
Mathilde Herbet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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