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Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

Comparative Analysis of the Predictive Performance of Noninvasive Beat-by-Beat Blood Pressure and Flow Measurements at the Lower Extremity Versus the Upper Extremity for Neonatal Outcomes Under Spinal Anesthesia for Elective Cesarean Delivery

Who can join

Ages 18 and older · Women · Healthy volunteers welcome

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• ClearSight (device)

Sponsor: Ohio State University · Participants: 327 · Started: Feb 6, 2025

Contact the study team

• Ling-Qun Hu, MD · Phone: 6142936302
• Alberto Uribe, MD · Phone: 6142933559

Official record on ClinicalTrials.gov — NCT07685730

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.