Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System

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.

NCT Number	NCT07333729
Lead Sponsor	University Hospital, Lille Collaborators: Clinical Investigation Centre for Innovative Technology Network
Conditions	Obstetrics: Elective Caesarean Delivery
Enrollment	50 participants
Start Date	2025-12-17
Primary Completion	2025-12-17 (estimated)
Study Completion	2026-12-17 (estimated)
Updated on ClinicalTrials.gov	2026-01-23