Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System

NCT07333729 | Recruiting

• 1 other identifier: 2024_0479
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Autonomic nervous system; Spinal anesthesia; Hypotension; Fetal heart rate; TOCONAUTE

Outcome Measures

Primary Outcomes (1)

• To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery.

  Rate of Fetal Stress Index (FSI) compared with the pre-anesthesia baseline, computed from continuous fetal heart-rate recordings acquired with the TOCONAUTE device.

  At 12 minutes after intrathecal injection

Secondary Outcomes (9)

• To assess the impact of spinal anesthesia on fetal autonomic nervous system activity at intermediate time points during elective cesarean delivery.

  At placement, at injection, 1 min, 3 min, 6 min and 9 min during elective cesarean delivery.

• To evaluate the evolution of maternal blood pressure following spinal anesthesia placement, up to 12 minutes after injection.

  At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes,

• To evaluate the evolution of cardiac output following spinal anesthesia

  At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes

• To evaluate the evolution of cardiac output following spinal anesthesia

  At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes

• Change in ANI measurements measured at placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes, relative to the pre-spinal anesthesia baseline, measured by ANI monitor medical device.

  At placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes

Study Arms (1)

TOCONAUTE + ANI RELECTURE

EXPERIMENTAL

Device: Recording of fetal and maternal heart rate

Interventions

Recording of fetal and maternal heart rate DEVICE

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.

TOCONAUTE + ANI RELECTURE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Investigation Centre for Innovative Technology Network: collaborator
• University Hospital, Lille: lead

Study Sites (1)

CHU de Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Charles Garabédian, PH

CONTACT

03 20 44 59 62; charles.garabedian@chu-lille.fr

Mathilde Herbet

CONTACT

03.62.94.38.19; mathilde.herbet@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 12, 2026
• Study Start: December 17, 2025
• Primary Completion: December 17, 2025
• Study Completion (Estimated): December 17, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)