NCT07333729

Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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) 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

Interventions

Type	Name	Description
DEVICE	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 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.

Timeline

• Start date: 2025-12-17
• Primary completion: 2025-12-17
• Completion: 2026-12-17
• First posted: 2026-01-12
• Last updated: 2026-01-23

Locations

1 site across 1 country: France