NCT07500519

Brief Summary

This prospective observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Post-spinal hypotension is a common complication that can affect maternal and fetal outcomes, and early identification of at-risk patients is essential for effective perioperative management.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress76%
Oct 2025Aug 2026

Study Start

First participant enrolled

October 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 18, 2026

Last Update Submit

March 25, 2026

Conditions

Spinal AnesthesiaPregnancyHypotension Postprocedural

Keywords

HypotensionCesarean SectionSpinal AnesthesiaShock Index

Outcome Measures

Primary Outcomes (1)

  • Predictive performances of preoperative shock indexes for intraoperative hypotension

    The ability of preoperative SI and MSI to predict intraoperative hypotension will be evaluated using receiver operating characteristic (ROC) analysis; area under the curve (AUC), sensitivity, specificity, and optimal cutoff values will be reported. SI is calculated as heart rate ÷ systolic blood pressure (HR/SBP); MSI is calculated as heart rate ÷ mean arterial pressure (HR/MAP). Hypotension is defined as a decrease of SBP to \<80% of baseline or SBP \<100 mmHg, or MAP \<80% of baseline or MAP \<65 mmHg.

    From induction of spinal anesthesia until end of surgery

Secondary Outcomes (3)

  • Incidence of intraoperative hypotension

    From induction of spinal anesthesia until end of surgery (intraoperative period)

  • Requirement for vasopressor treatment (ephedrine)

    From induction of spinal anesthesia until end of surgery

  • Classification into hypotension vs. no-hypotension groups for comparison analyses

    Intraoperative period

Study Arms (2)

Postspinal hypotension

All patients undergoing elective cesarean surgery under spinal anesthesia will be included in this study. Preoperative Shock Index (SI) and Modified Shock Index (MSI) will be calculated prior to anesthesia. Patients will be monitored during the surgery for hypotension. The patients who experience hypotension will be recorded as the post spinal hypotension group. The predictive performance of SI and MSI for post-spinal hypotension will be analyzed.

Post spinal non-hypotension

All patients undergoing elective cesarean surgery under spinal anesthesia will be included in this study. Preoperative Shock Index (SI) and Modified Shock Index (MSI) will be calculated prior to anesthesia. Patients will be monitored during the surgery for hypotension. The patients who do not experience hypotension will be recorded as the post spinal non-hypotension group. The predictive performance of SI and MSI for post-spinal hypotension will be analyzed

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants only (pregnant women undergoing elective cesarean surgery)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of pregnant women undergoing elective cesarean surgery under spinal anesthesia at Marmara University School of Medicine, Department of Anesthesiology.

You may qualify if:

  • Patients over 18 years old
  • ASA II-III patients undergoing elective cesarean section

You may not qualify if:

  • ASA IV patients
  • Patients with known neurologic or psychiatric disorders
  • Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
  • Patients with alcohol or drug addiction
  • Mentally disabled patients
  • Patients with BMI\>30
  • Patients who develop massive bleeding or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Beliz Bilgili

CONTACT

+905362187927belizbilgili@gmail.com

Beyza Betül Özkurt

CONTACT

+905302992210beyzaozkurt@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 30, 2026

Study Start

October 15, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

TU(1)