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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Lille
RECRUITING
Lille
Contact Information
Primary
Charles Garabédian, PH
charles.garabedian@chu-lille.fr
03 20 44 59 62
Backup
Mathilde Herbet
mathilde.herbet@chu-lille.fr
03.62.94.38.19
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2026-12-17
Participants
Target number of participants: 50
Treatments
Experimental: TOCONAUTE + ANI RELECTURE
Related Therapeutic Areas
Sponsors
Collaborators: Clinical Investigation Centre for Innovative Technology Network
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov