Regulatory update on a not yet recruiting intrapartum autonomic heart rate monitoring device trial aimed at reducing neonatal risk and improving obstetric decision making.
As of February 15, 2026, a not yet recruiting trial evaluates an autonomic nervous system based intrapartum monitoring device designed to record fetal and maternal heart rates during labor. The study is sponsored by University Hospital Lille and the Clinical Investigation Centre for Innovative Technology Network and is listed on ClinicalTrials.gov under NCT07409545. The purpose is to gather objective data to support obstetric care decisions and to inform future regulatory evaluation of the device.
What is this intrapartum autonomic monitoring study about?
The source describes a device that records fetal and maternal heart rate during labor. The trial is categorized under obstetrics and is not yet recruiting. Sponsorship comes from University Hospital Lille and the Clinical Investigation Centre for Innovative Technology Network. The ClinicalTrials.gov listing confirms the identifier NCT07409545.
How does the device function in clinical practice?
The primary function documented is recording fetal and maternal heart rates during labor. This information is intended to support obstetric decision making and clinical care. The description does not provide additional specifications in the source text.
What is the regulatory context for such monitoring devices?
The project aligns with regulatory expectations for medical devices that monitor physiological signals in obstetrics. The text notes an intended use and the need for safety and performance evaluation as part of the regulatory process. The sponsor organizations are University Hospital Lille and the Clinical Investigation Centre for Innovative Technology Network.
What safety and performance considerations are described?
In the provided source there are no safety outcomes or performance data. The description focuses on the device role and the status not yet recruiting. Any regulatory decision will rely on defined intended use and appropriate safety monitoring as is standard for medical devices.
What is the status and timeline?
The listing states not yet recruiting. The sponsors include a university hospital in Lille and a network for innovation. The ClinicalTrials.gov record carries the identifier NCT07409545 and a direct link to the posted information.
FAQ
- 1. What is the device used for? It records fetal and maternal heart rate during labor to support monitoring and data collection for regulatory evaluation.
- 2. Who is conducting the study? University Hospital Lille and the Clinical Investigation Centre for Innovative Technology Network.
- 3. Where can I find the trial record? The ClinicalTrials.gov listing for NCT07409545.
Conclusion
The project describes a straightforward approach to intrapartum monitoring using a device that records heart rates. The documentation signals that regulatory evaluation will cover intended use, performance and safety. Stakeholders in obstetrics and device regulation should monitor updates as recruitment status or study findings become available.
Disclaimer
This content is intended for professionals. It is not legal advice. For regulatory guidance consult applicable authorities and MDR Annex XIV guidance.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07409545?term=medical+device