NCT07496788

Brief Summary

This prospective, single-center observational study aims to evaluate the predictive value of the internal jugular vein collapsibility index (IJVCI) for spinal anesthesia-associated hypotension in preeclamptic parturients (gestational age ≥28 weeks) undergoing cesarean delivery classified as Lucas category 3-4. Preoperative IJVCI will be measured using ultrasonography before spinal anesthesia during spontaneous and deep respiration. The incidence of hypotension within the first 20 minutes after spinal anesthesia will be recorded. The diagnostic performance of IJVCI in predicting hypotension will be analyzed.

Trial Health

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Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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 Progress53%
May 2026Jul 2026

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

PreeclampsiaSpinal AnesthesiaHypotensionInternal Jugular VeinCollapsibility IndexCesarean SectionUltrasonographyHemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

  • Predictive Value of Internal Jugular Vein Collapsibility Index for Spinal Anesthesia-Induced Hypotension

    Diagnostic performance of the preoperative internal jugular vein collapsibility index (IJVCI) for predicting spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia, assessed by receiver operating characteristic (ROC) curve analysis. Hypotension will be defined as a ≥30% decrease in mean arterial pressure from baseline or systolic blood pressure \<100 mmHg.

    From spinal anesthesia administration to 20 minutes post-spinal anesthesia

Study Arms (1)

Preeclamptic Parturients Undergoing Cesarean Section

Preeclamptic pregnant women aged 18-45 years with ASA physical status II-III and gestational age ≥28 weeks who are scheduled for cesarean delivery under spinal anesthesia, with cesarean urgency classified as Lucas category 3-4. Preoperative internal jugular vein collapsibility index (IJVCI) will be measured using ultrasonography before spinal anesthesia, and participants will be followed for the development of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia.

Other: Internal Jugular Vein Collapsibility Index Measurement

Interventions

Preoperative ultrasonographic measurement of the internal jugular vein collapsibility index (IJVCI) performed before spinal anesthesia in preeclamptic parturients (gestational age ≥28 weeks) undergoing cesarean delivery classified as Lucas category 3-4.

Preeclamptic Parturients Undergoing Cesarean Section

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes only female participants because it investigates preeclamptic pregnant women undergoing cesarean delivery under spinal anesthesia, with cesarean urgency classified as Lucas category 3-4. Preeclampsia is a pregnancy-specific condition and therefore occurs only in pregnant women.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women diagnosed with preeclampsia who are scheduled for cesarean delivery under spinal anesthesia at Ankara Bilkent City Hospital, with cesarean urgency classified as Lucas category 3-4. Eligible participants are aged 18-45 years, have ASA physical status II-III, and have a gestational age ≥28 weeks. Participants will be evaluated for the development of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia..

You may qualify if:

  • Age between 18 and 45 years
  • ASA physical status II-III
  • Diagnosed with preeclampsia
  • Scheduled for cesarean delivery under spinal anesthesia with cesarean urgency classified as Lucas category 3-4
  • Gestational age ≥28 weeks
  • Provided written informed consent

You may not qualify if:

  • Cesarean urgency classified as Lucas category 1-2
  • Gestational age \<28 weeks
  • ASA physical status ≥ IV
  • Known renal disease
  • Cardiac instability or known arrhythmia
  • Requirement of general anesthesia or sedation
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pre-EclampsiaHypotension

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nihan Aydin Guzey, MD, PhD

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nihan Aydin Guzey, MD, PhD

CONTACT

Basak Mizrak Demirbuken, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Nihan Aydin Guzey

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

July 25, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations