Spinal anesthesia effects on the baby's autonomic nervous system during an elective C-section
Evaluation of the Impact of Spinal Anesthesia on the Fetal Autonomic Nervous System During an Elective Caesarean Delivery
We will test whether spinal anesthesia given for an elective C-section changes fetal autonomic activity, measured by a fetal stress index, in full-term pregnant women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT07333729 on ClinicalTrials.gov |
What this trial studies
This pilot study at CHU de Lille records continuous beat-to-beat fetal and maternal heart rates around elective cesarean deliveries to derive heart rate variability markers and a Fetal Stress Index (FSI). The FSI is designed to quantify fetal parasympathetic activity and was developed from prior preclinical correlations with fetal acidosis. Researchers will compare FSI and other HRV markers before and after maternal spinal anesthesia and during any episodes of maternal hypotension. Results will explore whether spinal anesthesia-related changes in maternal blood pressure correspond to measurable fetal autonomic changes.
Who should consider this trial
Good fit: Pregnant women aged 18–44 with a singleton pregnancy at or beyond 37 weeks who are scheduled for an elective cesarean, can consent, speak French, and are covered by national health insurance are ideal candidates.
Not a fit: Patients who need general anesthesia or combined epidural-spinal analgesia, have fetal malformations, fetal demise, cardiac rhythm disorders, implanted cardiac devices, are on medications that alter autonomic activity, or have multiple gestations are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could help detect fetal stress related to maternal hypotension and guide anesthesia or monitoring decisions to reduce the risk of fetal acidosis.
How similar studies have performed: Previous HRV research and preclinical work support using HRV to track autonomic changes and the FSI has shown correlation with parasympathetic fluctuations and fetal acidosis in preclinical studies, but the fetal-specific FSI is not yet widely validated in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille
- CHU de Lille — Lille, France (Recruiting)
Study contacts
- Study coordinator: Charles Garabédian, PH
- Email: charles.garabedian@chu-lille.fr
- Phone: 03 20 44 59 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.