About this trial
This is a single-center, prospective observational study in patients undergoing cesarean delivery under spinal or combined spinal-epidural anesthesia. It compares whether continuous noninvasive hemodynamic measurements from the lower extremity (toe) better predict neonatal outcomes than upper extremity (arm/finger) measurements during spinal-induced hypotension.
Participants receive standard spinal anesthesia and routine blood pressure management, with additional monitoring using the ClearSight™ system at both upper and lower extremities from before spinal anesthesia through delivery.
The primary outcome is a composite of neonatal outcomes (APGAR scores, need for respiratory support, cord gases, and NICU admission). Secondary outcomes include maternal side effects and comfort.
Overall, the study evaluates whether lower-extremity hemodynamic monitoring improves detection of clinically relevant hypotension and prediction of neonatal outcomes compared to traditional arm measurements.
Eligibility criteria
Qualifiers
Age ≥ 18 years old
Singleton pregnancy
Gestational age ≥ 37 weeks
Women undergoing CD under SAB or Combined Spinal-Epidural (CSE) electively.
Disqualifiers
CD under or converted to general anesthesia
CD under epidural anesthesia or converted to epidural anesthesia
Diabetes Mellitus (DM)/Gestational Diabetes Mellitus (GDM)
Evidence of unstable cardiac disease other than HDP (including chronic hypertension, gestational hypertension, preeclampsia-eclampsia, and chronic hypertension with superimposed preeclampsia) judged by the investigator to have any impact on BP will make the subject unsuitable for participation in the study
Trial design
Treatments tested in this trial
- ClearSight