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Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System

RecruitingNAAges 18 Years - 45 YearsFemaleUniversity Hospital, Lille
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Pregnant woman scheduled for elective cesarean delivery * Age: over 18 and under 45 years * Gestational age โ‰ฅ 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
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What it tests

  • Recording of fetal and maternal heart rate
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Where

1 site
CHU de Lille
Lille, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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