Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System (RACHISNA)

University Hospital, Lille

Status

Enrolling

Conditions

Obstetrics: Elective Caesarean Delivery

Treatments

Device: Recording of fetal and maternal heart rate

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT07333729

2024_0479

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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