NCT07539896

Brief Summary

Spinal anesthesia is widely preferred for elective cesarean delivery due to its favorable safety profile and superior postoperative analgesia. However, post-spinal hypotension (PSH) remains a common complication, with reported incidence rates ranging from 40% to 70%, potentially compromising maternal hemodynamic stability and uteroplacental perfusion. Early identification of patients at high risk for PSH is therefore of critical clinical importance. This prospective observational study aims to evaluate the predictive performance of preoperative internal jugular vein collapsibility index (IJV-CI), assessed by ultrasonography, and baseline perfusion index (PI), obtained via pulse oximetry, for the development of PSH in patients undergoing elective cesarean section under spinal anesthesia. While IJV-CI reflects intravascular volume status and preload, PI represents peripheral vascular tone; thus, their combined use may improve predictive accuracy. Study Design This is a single-center, prospective observational study conducted in patients scheduled for elective cesarean delivery under spinal anesthesia. No additional intervention will be applied, and all anesthetic management will follow standard clinical practice. Objectives Primary Objective: To assess the ability of preoperative IJV collapsibility index (IJV-CI) and baseline perfusion index (PI) to predict post-spinal hypotension. Secondary Objectives: To evaluate the relationship between IJV-CI and PI with: Duration and number of hypotensive episodes Minimum systolic and mean arterial pressure Total vasopressor requirement Incidence of intraoperative nausea and vomiting Pregnant women aged 18-45 years, ASA II, with singleton pregnancies scheduled for elective cesarean section under spinal anesthesia. Inclusion Criteria Age 18-45 years Elective cesarean section Planned spinal anesthesia ASA physical status II Singleton pregnancy Exclusion Criteria Hypertensive disorders of pregnancy (e.g., preeclampsia, HELLP) Significant cardiac or pulmonary disease Chronic kidney disease Multiple pregnancy Emergency cesarean delivery Conversion to general anesthesia Conditions preventing IJV ultrasonographic assessmentBaseline PI will be recorded preoperatively using standard pulse oximetry. IJV diameters will be measured via ultrasound, and the collapsibility index will be calculated as: IJVI: (Dmax-Dmin/Dmax)X100 Hemodynamic parameters will be recorded at 3-minute intervals from spinal anesthesia administration until delivery. Statistical analysis will include ROC curve analysis, correlation analysis, and logistic regression to evaluate predictive performance.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 25, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post- Spinal Hypotension

    Occurrence of Post-Spinal Hypotension Defined as a ≥20% decrease in mean arterial pressure (MAP) from baseline.

    From spinal anesthesia administration until delivery

Interventions

In predicting hypotension during cesarean delivery with spinal anesthesia, two parameters will be used together

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women undergoing elective cesarean section under spinal anesthesia at a tertiary care hospital.

You may qualify if:

  • Age 18-45 years Singleton pregnancy Scheduled for elective cesarean section Planned spinal anesthesia ASA physical status II

You may not qualify if:

  • Hypertensive disorders of pregnancy (e.g., preeclampsia, HELLP syndrome) Known significant cardiac disease or pulmonary hypertension Chronic kidney disease Hemoglobinopathies Multiple pregnancy Emergency cesarean section Conversion to general anesthesia Anatomical or pathological conditions preventing IJV ultrasound assessment -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 20, 2026

Study Start

April 25, 2026

Primary Completion (Estimated)

June 25, 2026

Study Completion (Estimated)

June 25, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share