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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Ohio
The Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Ling-Qun Hu, MD
LingQun.Hu@osumc.edu
6142936302
Backup
Alberto Uribe, MD
Alberto.uribe@osumc.edu
6142933559
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2029-08-06
Participants
Target number of participants: 327
Treatments
Pregnant Women undergoing Cesarean Delivery
Related Therapeutic Areas
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov