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