Recruiting NCT07333729

Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System

No phase Interventional Obstetrics: Elective Caesarean Delivery

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Recording of fetal and maternal heart rate.
Who it may be relevant to: Registry conditions: Obstetrics: Elective Caesarean Delivery. Basic parameters: 18 years — 45 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
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Official title

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

Overview

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.

Interventions

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 collec

Primary outcome measures

To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery. [Time frame: At 12 minutes after intrathecal injection]

Secondary outcome measures (9)

To assess the impact of spinal anesthesia on fetal autonomic nervous system activity at intermediate time points during elective cesarean delivery. [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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. [Time frame: At placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes]
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status. [Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes]
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status. [Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes]
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status. [Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes]
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status. [Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Diagnostic

Study locations

France · 1 center

CHU de Lille — Lille

Identifiers

NCT: NCT07333729 · 2024_0479

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗