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Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

Recruitingn/aAges 18 Years - anyFemaleOhio State University
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In plain words

What the trial is, and whether it could suit you

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 ClearSightโ„ข 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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years old * Singleton pregnancy * Gestational age โ‰ฅ 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
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What it tests

  • ClearSight
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Where

1 site
The Ohio State University
Columbus, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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