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Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

Ohio State University · NCT07685730

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
327
US sites recruiting
1
Study start
February 6, 2025
Record last updated
July 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ClearSight

Conditions: Anesthesia; Pregnancy Related; Blockades Neuromuscular

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Alberto Uribe, MD · 6142933559 · alberto.uribe@osumc.edu

Study contacts (from the official record)

  • Ling-Qun Hu, MD · 6142936302 · LingQun.Hu@osumc.edu
  • Alberto Uribe, MD · 6142933559 · Alberto.uribe@osumc.edu
All pregnancy studies in Ohio →
Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight (NCT07685730) | Bored Studies