Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System (NCT07333729) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
France50 participantsStarted 2025-12-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery.
Timeframe: At 12 minutes after intrathecal injection