Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
This study is about understanding how spinal anaesthesia, commonly used during planned C-sections, might affect an unborn baby's automatic body functions, like their heart rate. Spinal anaesthesia is generally very safe, but sometimes it can briefly lower the mother's blood pressure, which might affect the baby. Researchers are using a new device to continuously measure the baby's heart rate and calculate a 'Fetal Stress Index' to see how the baby's nervous system responds. They are also monitoring the mother's nervous system. The main goal is to learn more about these effects so that doctors can continue to provide the best care for both mother and baby during C-sections.
At a glance
What is this study about?
When a mum-to-be has a planned C-section, doctors often use a type of pain relief called spinal anaesthesia. This is generally a very safe and common procedure. However, a known side effect can be a temporary drop in the mother's blood pressure. If this happens, it could briefly affect the amount of blood flow to the baby, which might impact the baby's automatic body functions. These functions are controlled by something called the autonomic nervous system, which helps keep things like heart rate and breathing regular.
Researchers at Lille University Hospital have developed a special way to measure these automatic responses in babies using very detailed heart rate monitoring. They use a special calculation called the 'Fetal Stress Index' (FSI) to understand how the baby's nervous system is working. This study will use a device called TOCONAUTE to continuously record the baby’s heart rate during planned C-sections where spinal anaesthesia is used. By looking at the FSI afterwards, the researchers hope to understand if and how the spinal anaesthesia affects the baby's automatic nervous system.
The study will also monitor the mother's automatic nervous system activity. By gathering all this information, the team hopes to learn more about how both mum and baby respond during a C-section with spinal anaesthesia. This knowledge could help doctors better predict and manage any temporary changes, ensuring the safest experience possible for every family.
Key takeaways
- This study helps understand spinal anaesthesia effects during C-sections.
- It uses safe, non-invasive monitoring for both mum and baby.
- The focus is on how a baby's heart rate and nervous system respond.
- It aims to improve future care for planned C-sections.
- Participation is voluntary and will not affect your medical care.
Who may be eligible?
To take part in this study, you need to be a pregnant woman having a planned C-section. You should be between 18 and 45 years old and at least 37 weeks pregnant with one baby. You also need to speak French well and be part of the national health insurance scheme. Importantly, you would need to give your written permission to join the study.
Several things would mean you couldn't join. For example, if you need general anaesthesia for your C-section, or if your baby has a known health issue. You also wouldn't be able to participate if you or your baby have certain heart problems, or if you have an implanted medical device like a pacemaker. People with severe skin conditions, or those taking medicines that affect their nervous system (like some heart medications), would also not be eligible.
Finally, if you're already in another medical study or have certain allergies to materials in the monitoring devices, you wouldn't be able to take part. The research team will carefully check all these points to make sure the study is right and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am pregnant and planning an elective (planned) C-section.
- I am between 18 and 45 years old.
- I am at least 37 weeks pregnant with one baby.
- I speak French.
- I do not have major heart problems for myself or my baby.
- I am not currently taking medications that affect my nervous system.
What does participation involve?
If you decide to take part, your participation would happen during your planned C-section. Researchers would use a special device called TOCONAUTE to continuously record your baby's heart rate from your tummy. Another device, called ANI, would monitor your own nervous system activity, likely through stick-on sensors. These devices are non-invasive, meaning they don't involve needles or surgery. The monitoring would happen during and shortly after your C-section. There are no extra hospital visits required beyond your standard C-section care, and no medication is given specifically for the study. The total duration of your active involvement would be limited to the time of your delivery and immediate recovery.
Potential risks and benefits
Locations (1)
- CHU de LilleVerified postcodeLille, France· Recruiting
Common questions
What is spinal anaesthesia?
It's a common and safe way to numb the lower half of your body for surgery, like a C-section, so you stay awake during the birth without feeling pain.
What is the 'Fetal Stress Index'?
It's a way researchers measure your baby's automatic body responses, like heart rate changes, to understand how their nervous system is working.
Will this study affect my C-section?
No, your C-section will go ahead as planned. The study involves adding monitoring devices during the procedure.
Are the monitoring devices safe for me and my baby?
Yes, these devices are designed to be safe and non-invasive, meaning they don't go inside your body.
Do I have to take part if I'm asked?
No, taking part is completely your choice. Your decision won't affect the care you receive.
How to find out more
Charles Garabédian, PH
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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