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Recruiting NCT07685730

Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

Conditions: Anesthesia, Pregnancy Related, Blockades Neuromuscular

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 327
Sponsor: Ohio State University

Location: The Ohio State University Columbus Ohio

Summary

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07685730). StuddyBuddy aggregates publicly available trial information.