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Clinical Trials in France / NCT07333729
Recruiting Not applicable

Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System

NCT07333729 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Lille
Phase
Not applicable
Started
2025-12-17
Last updated
2026-01-23

Condition(s) studied

Obstetrics: Elective Caesarean Delivery

Investigational drug(s) / intervention(s)

Recording of fetal and maternal heart rate

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.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery. — At 12 minutes after intrathecal injection
    Rate of Fetal Stress Index (FSI) compared with the pre-anesthesia baseline, computed from continuous fetal heart-rate recordings acquired with the TOCONAUTE device.

Trial sites (1)

FacilityCityRegionStatus
CHU de Lille Lille France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07333729 on ClinicalTrials.gov ↗ ← All trials in France