Lower-extremity blood pressure monitoring during cesarean under spinal anesthesia
Official title: 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
Run by Ohio State University · NCT07685730 · Data updated 2026-11-12
This study tests whether noninvasive blood pressure monitoring from the toe is better than the arm at predicting neonatal outcomes during cesarean delivery with spinal anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 327 (estimated) |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | February 6, 2025 |
| Main results expected | February 6, 2029 |
| Study ends | August 6, 2029 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07685730 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18 or older with singleton pregnancies undergoing elective cesarean delivery under spinal or combined spinal-epidural anesthesia, able to consent in English or Spanish.
✕Probably not a fit
Patients with general anesthesia, non-singleton pregnancies, or those unable to consent in English or Spanish may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective single-center observational study enrolling women undergoing elective cesarean delivery under spinal or combined spinal-epidural anesthesia. The study compares continuous hemodynamic data from upper and lower extremities using the ClearSight system to see which location more accurately predicts neonatal outcomes such as APGAR scores, need for respiratory support, cord gases, and NICU admission. Standard perioperative care is provided, with additional simultaneous monitoring at the arm and toe from before spinal anesthesia through delivery. Data will be analyzed to determine whether lower-extremity measurements improve detection of hypotension and prediction of neonatal outcomes beyond traditional arm measurements. No extra interventions beyond routine care are performed.
Why it matters
Potential benefit: If successful, lower-extremity monitoring could improve early detection of clinically relevant hypotension and help predict neonatal outcomes more accurately.
How similar studies have gone: Prior studies have explored upper-extremity monitoring for obstetric anesthesia; this study investigates a novel comparison with lower-extremity monitoring to predict neonatal outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The Ohio State University
Columbus, Ohio, United States Recruiting
Study contacts
- Study coordinator: Ling-Qun Hu, MD
- Email: LingQun.Hu@osumc.edu
- Phone: 6142936302
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.