Evaluation of the Impact of Spinal Anesthesia on the Fetal Autonomic Nervous System During an Elective Caesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TOCONAUTE + ANI RELECTURE
干预措施: Recording of fetal and maternal heart rate (Device)
结局指标
主要结局
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery.
时间窗: 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.
次要结局
- 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 compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.(At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes)
- 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,)
- 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)
- To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.(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.(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.(At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +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)