Recruiting

Hemodynamic Monitoring

Sponsor:

Ohio State University

Code:

NCT07685730

Conditions

Anesthesia

Pregnancy Related

Blockades Neuromuscular

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

ClearSight

Study Details

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

Study ID

NCT07685730

Start date

Feb 6, 2025

Status verified date

Jun, 2026

Completion date

Aug 6, 2029

Anticipated

Primary completion date

Feb 6, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

327 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant Women undergoing Cesarean Delivery

Interventions

ClearSight

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.

Primary outcome measure

  • Incidences of FAAAN composite poor neonatal outcomes [ Time Frame: 24 Hours after delivery ]

Central Contacts and Locations

Central contacts

Ling-Qun Hu, MD

6142936302LingQun.Hu@osumc.edu

Alberto Uribe, MD

6142933559Alberto.uribe@osumc.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Alberto Uribe, MD

6142933559alberto.uribe@osumc.edu

Ling-Qun Hu, MD

6142936302LingQun.Hu@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-06.