Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

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

Вторичные конечные точки (9)

• To assess the impact of spinal anesthesia on fetal autonomic nervous system activity at intermediate time points during elective cesarean delivery. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• CHU de Lille — Lille

Идентификаторы

NCT: NCT07333729 · 2024_0479

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗