An interventional study of Recording of fetal and maternal heart rate in Obstetrics: Elective Caesarean Delivery, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
Device: Recording of fetal and maternal heart rate
This study will be conducted in the maternity ward of the Jeanne de Flandre Maternity, Lille University Hospital, specifically in the operating room for cesarean delivery. The TOCONAUTE device will be placed on the mother's abdomen to record fetal heart rate. Recordings will be analyzed retrospectively using the ANI RELECTURE software to calculate the Fetal Stress Index (FSI). Participants will also be connected to the Analgesia Nociception Index (ANI) monitor and the ClearSight system to collect maternal cardiac output, heart-rate variability (HRV) indices, and continuous blood-pressure data. For each participant, the TOCONAUTE will remain in place on the abdomen for 12 minutes after intrathecal injection. These procedures will not interfere with the standard clinical care provided to the pregnant woman.
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity during elective cesarean delivery.
Rate of Fetal Stress Index (FSI) compared with the pre-anesthesia baseline, computed from continuous fetal heart-rate recordings acquired with the TOCONAUTE device.
Time frame: At 12 minutes after intrathecal injection
To assess the impact of spinal anesthesia on fetal autonomic nervous system activity at intermediate time points during elective cesarean delivery.
Rate of Fetal Stress Index (FSI) at multiple intermediate time points after intrathecal injection (at placement, at injection (T0) and at T+1, T+3, T+6, and T+9 minutes) compared with the pre-anesthesia baseline, computed from continuous fetal heart-rate recordings acquired with the TOCONAUTE device.
Time frame: At placement, at injection, 1 min, 3 min, 6 min and 9 min during elective cesarean delivery.
To evaluate the evolution of maternal blood pressure following spinal anesthesia placement, up to 12 minutes after injection.
Change from baseline in ClearSight® (Edwards Lifesciences®) monitoring parameters (systolic arterial pressure (SAP), mean arterial pressure (MAP) measured at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes, relative to the pre-spinal anesthesia baseline.
Time frame: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes,
To evaluate the evolution of cardiac output following spinal anesthesia
Change from baseline in ClearSight® (Edwards Lifesciences®) monitoring parameter: cardiac index (CI) measured relative to the pre-spinal anesthesia baseline.
Time frame: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
To evaluate the evolution of cardiac output following spinal anesthesia
Change from baseline in ClearSight® (Edwards Lifesciences®) monitoring parameter: Hypotension Prediction Index (HPI) measured relative to the pre-spinal anesthesia baseline.
Time frame: At intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
Change in ANI measurements measured at placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes, relative to the pre-spinal anesthesia baseline, measured by ANI monitor medical device.
Change in ANI measurements measured relative to the pre-spinal anesthesia baseline.
Time frame: At placement, at intrathecal injection (T0) and at T+1, T+3, T+6, T+9, and T+12 minutes
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.
Rate of FSI (Fetal Stress Index) and HPI (Hypotension Prediction Index) measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes.
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the maternal hypotension status.
Rate of FSI and ANI measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes.
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal heart rate variability markers measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status.
Rate of FSI and HPI measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes, with analyses stratified by the presence or absence of neonatal acidosis (defined as umbilical arterial pH \< 7.20 at birth).
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
To compare fetal and maternal cardiac output values measured during the 12 minutes following spinal anesthesia placement, according to the neonatal acidosis status.
Rate of FSI and ANI measured at placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes, with analyses stratified by the presence or absence of neonatal acidosis (defined as umbilical arterial pH \< 7.20 at birth).
Time frame: At placement, at intrathecal injection (T0) and at T+1, +3, +6, +9, and +12 minutes
Plan to share: No
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University Hospital, Lille