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ClearSight Monitoring During Cesarean Delivery

This observational study is looking at whether continuous blood pressure measurements from your toe (lower extremity) are better at predicting how your baby will do after a cesarean delivery than measurements from your arm or finger (upper extremity). This is for women having a cesarean delivery with spinal anesthesia. You will receive standard spinal anesthesia and routine blood pressure care. The ClearSight™ system, which measures blood pressure non-invasively, will be used on both your upper and lower body. The main goal is to see if these measurements can predict a combination of poor neonatal (newborn) outcomes, like Apgar scores and need for breathing support, within 24 hours after delivery. This study is currently unclear on its recruitment status and plans to enroll 327 participants.

Study design
This is an observational study, meaning researchers will watch and record information without giving new treatments. It plans to include 327 participants.
What's involved
You will have the ClearSight™ system applied to both your upper and lower extremities from 3 minutes before spinal anesthesia until 3 minutes after your baby is delivered. Routine blood pressure measurements will also be taken.
Compensation
Not stated in the trial record.
Follow-up
Neonatal outcomes will be measured at 24 hours after delivery.

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NCT07685730

Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

Recruiting
Not specifiedAges 18+Observational
Ohio State University
~327 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:ClearSight

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidences of FAAAN composite poor neonatal outcomes
Measured over 24 Hours after delivery

Conditions

Anesthesia
Pregnancy Related
Blockades Neuromuscular

Explore related trials

Cesarean SectionPregnancy

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Ling-Qun Hu, MD
[email protected]
6142936302
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidences of FAAAN composite poor neonatal outcomes24 Hours after delivery

    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.