Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
NCT ID: NCT07333729
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-12-17
2026-12-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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TOCONAUTE + ANI RELECTURE
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Clinical Investigation Centre for Innovative Technology Network
NETWORK
University Hospital, Lille
OTHER
Responsible Party
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Locations
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CHU de Lille
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024_0479
Identifier Type: -
Identifier Source: org_study_id
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