The potential effects of spinal anesthesia on the fetal autonomic nervous system during elective caesarean delivery are under investigation in a new clinical trial. This study, sponsored by the University Hospital in Lille and the Clinical Investigation Centre for Innovative Technology Network, has generated interest among clinical, quality, and regulatory teams.
As of the publication date, January 13, 2026, recruitment for the study has yet to begin. The focus is on maternal and fetal heart rate monitoring as part of the trial’s intervention design. This research could provide critical insights into the safety and performance of spinal anesthesia in obstetric care.
- What is the objective of this study?
- How is this trial structured?
- What are the potential implications?
- FAQs
- Conclusion
- Disclaimer
- Announcement
What is the objective of this study?
The trial aims to assess the effects of spinal anesthesia on the fetal autonomic nervous system. The specific area of research focuses on how the method impacts maternal and fetal heart rates during planned caesarean deliveries. Spinal anesthesia is a standard technique in obstetrics, but detailed information on its implications for fetal autonomic control is limited. This clinical trial seeks to fill this gap with real-world data.
How is this trial structured?
This prospective study is categorized as a non-interventional research trial conducted in a controlled obstetric setting. During the procedure, the heart rates of both the mother and fetus will be recorded using a medical device. These recordings will be used to analyze how spinal anesthesia correlates with changes in fetal autonomic nervous system activity.
The involvement of specialized centers like the Clinical Investigation Centre for Innovative Technology Network ensures adherence to regulatory standards in data collection and device performance monitoring. Results from this study aim to support better clinical decision-making in the obstetric care pathway.
What are the potential implications?
This research has the potential to advance the safety profile of spinal anesthesia in pregnant patients, particularly regarding fetal outcomes. It may influence clinical guidelines and inform regulatory submissions involving anesthesia methods in obstetrics. Beyond immediate implications for elective caesarean sections, this data could also shape future innovations in fetal monitoring technology.
Professionals in healthcare, medical device development, and regulatory affairs will find this trial relevant as it exemplifies rigorous safety and performance evaluation. Updates on study progress and outcomes could offer actionable insights into optimizing maternal and neonatal care globally.
FAQs
- 1. Who is sponsoring the study?
The sponsors are the University Hospital, Lille, and the Clinical Investigation Centre for Innovative Technology Network. - 2. What is the intervention used?
The intervention focuses on recording fetal and maternal heart rates using a medical device. - 3. Is this study currently recruiting?
As of January 2026, the trial has not yet begun recruitment.
Conclusion
This clinical trial exploring spinal anesthesia’s effects on fetal autonomic response holds promise for improving obstetric care. By addressing key safety and performance questions, it aligns with the broader goals of medical device regulation and patient outcomes. Stakeholders are encouraged to monitor this trial for updates.
Disclaimer
The information provided in this article is for professional purposes only and does not constitute legal or regulatory advice.
Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07333729?term=medical+device