Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight
Recruiting now
Conditions studied: Anesthesia, Pregnancy Related, Blockades Neuromuscular
In brief
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.
Key facts
- Study ID
- NCT07685730
- Run by
- Ohio State University
- People needed
- 327
- Starts
- 2025-02-06
- Expected to finish
- 2029-08-06
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 18 years old
- Singleton pregnancy
- Gestational age ≥ 37 weeks
- Women undergoing CD under SAB or Combined Spinal-Epidural (CSE) electively.
- Ability to consent in English and in Spanish language
You may not qualify if…
- 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
- Documented fetal anomaly/ congenital malformations and genetic syndromes
- Intrauterine growth retardation
- Unable to consent in English/Spanish.
- Prisoners
Where it is running
- The Ohio State University — Columbus, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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