Postspinal HypotensionNCT07539896
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
An observational study of Postspinal Hypotension and Cesarean Birth, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postspinal Hypotension, Cesarean Birth
- What is being tested?
- Baseline PI will be recorded,IJV diameters will be measured via ultrasound
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2026to 25 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women undergoing elective cesarean section under spinal anesthesia at a tertiary care hospital.
Who may be able to join
- Age 18-45 years Singleton pregnancy Scheduled for elective cesarean section Planned spinal anesthesia ASA physical status II
Who cannot join
- 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 -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Postspinal Hypotension, Cesarean Birth
- Being tested
- Baseline PI will be recorded,IJV diameters will be measured via ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline PI will be recorded,IJV diameters will be measured via ultrasoundOther
In predicting hypotension during cesarean delivery with spinal anesthesia, two parameters will be used together
What is being measured
The primary outcome is the main question the study is designed to answer.
Post- Spinal Hypotension
Occurrence of Post-Spinal Hypotension Defined as a ≥20% decrease in mean arterial pressure (MAP) from baseline.
Measured: From spinal anesthesia administration until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start25 Apr 2026 (estimated)
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postspinal HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sen, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539896
- Sponsor's protocol ID
- Muğla Training and Research Ho
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07539896
- Acronym / sponsor ID
- Muğla Training and Research Ho
- Conditions
- Postspinal Hypotension, Cesarean Birth
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing elective cesarean section under spinal anesthesia at a tertiary care hospital.
Key inclusion criteria (1 listed)
- Age 18-45 years Singleton pregnancy Scheduled for elective cesarean section Planned spinal anesthesia ASA physical status II
Key exclusion criteria (1 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline PI will be recorded,IJV diameters will be measured via ultrasoundIn predicting hypotension during cesarean delivery with spinal anesthesia, two parameters will be used together | Other | – |
Primary outcome
Post- Spinal Hypotension
Time frame: From spinal anesthesia administration until delivery
Occurrence of Post-Spinal Hypotension Defined as a ≥20% decrease in mean arterial pressure (MAP) from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Postspinal Hypotension and Cesarean Birth, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özlem Şen (+90 (506) 359 1751, turanozlem1@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post- Spinal Hypotension (time frame: From spinal anesthesia administration until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.