Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

NCT07685730 | Recruiting FDA Device

• 1 other identifier: 2024H0319
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Pregnancy Related; Blockades Neuromuscular

Outcome Measures

Primary Outcomes (1)

• Incidences of FAAAN composite poor neonatal outcomes

  FAAAN is a composite neonatal outcome measure used in this study to capture clinically relevant indicators of neonatal well-being and immediate post-delivery support needs. It includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), and NICU admission. The primary outcome is the incidence of a composite of poor neonatal outcomes, referred to as FAAAN. This composite includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), NICU admission, cord blood gas abnormalities, and delayed cord clamping.

  24 Hours after delivery

Secondary Outcomes (1)

• Maternal nausea/vomiting, arm, finger, and toe comfort, and shivering

  24 Hours after delivery

Study Arms (1)

Pregnant Women undergoing Cesarean Delivery

Device: ClearSight

Interventions

ClearSight DEVICE

The ClearSight system provides continuous blood pressure and advanced hemodynamic parameters from a noninvasive finger cuff sensor. Therefore, placing both cuff sensors in different arms will ensure no interference with the ClearSight readings due to the conventional blood pressure cuff inflation.

Pregnant Women undergoing Cesarean Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study includes adults, children, English- or Spanish-speaking individuals, and pregnant women (and their fetuses). It excludes adults with impaired decision-making capacity, nonviable neonates, neonates of uncertain viability, and prisoners. Eligible participants must be ≥18 years old, able to provide consent in English or Spanish, and have a singleton pregnancy at ≥37 weeks gestation. Exclusion criteria include documented fetal anomalies, congenital malformations, or genetic conditions; unstable cardiac disease (other than hypertensive disorders of pregnancy) that may affect blood pressure; and intrauterine growth restriction. Prisoners and other vulnerable populations are excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Central Study Contacts

Ling-Qun Hu, MD

CONTACT

6142936302; LingQun.Hu@osumc.edu

Alberto Uribe, MD

CONTACT

6142933559; Alberto.uribe@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: February 6, 2025
• Primary Completion (Estimated): February 6, 2029
• Study Completion (Estimated): August 6, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)