Cesarean Section ComplicationsNCT05953129
Novel Predictors of Post Spinal Hypotension in Cesarean Sections: Evaluating Jugular Vein Collapsibility Index and Shock Indices
An observational study of Cesarean Section Complications and Regional Anesthesia Morbidity, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Regional Anesthesia Morbidity, Hemodynamic Instability
- What is being tested?
- Right Jugular Vein Collapsibility Index
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between the ages of 18-45 who were scheduled for cesarean section and who gave consent to participate in the study and to apply spinal anesthesia will be included in this study.
Who may be able to join
- Pregnant women between the ages of 18-45 who had a planned cesarean section and approved to participate in the study and to apply spinal anesthesia
Who cannot join
- Patients with Preeclampsia, Eclampsia, HELLP syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training Research Hospital
Istanbul, 34255
About this study
Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.
- Conditions
- Cesarean Section Complications, Regional Anesthesia Morbidity, Hemodynamic Instability, Shock
- Being tested
- Right Jugular Vein Collapsibility Index
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Jugular Vein Collapsibility IndexDiagnostic test
Ultrasonography will be used to evaluate the diameter of the jugular vein (minimum and maximum values) and carotid diameter. The jugular vein collapsibility index will be measured by the anesthesiologist using non-invasive ultrasonography. Jugular vein collapsibility index will be calculated using the measured diameters.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of hypotension
To evaluate the ability of the jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) to predict post spinal hypotension in cesarean section surgeries.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start15 Jun 2023
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oguz Özakın, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953129
- Sponsor's protocol ID
- 126
- Status last verified
- Nov 2025
- First submitted
- 12 Jul 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Predictors of Post Spinal Hypotension in Cesarean Sections: Evaluating Jugular Vein Collapsibility Index and Shock Indices
- ClinicalTrials.gov ID
- NCT05953129
- Acronym / sponsor ID
- 126
- Conditions
- Cesarean Section Complications, Regional Anesthesia Morbidity, Hemodynamic Instability, Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 19 Jul 2023 (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.
Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between the ages of 18-45 who were scheduled for cesarean section and who gave consent to participate in the study and to apply spinal anesthesia will be included in this study.
Key inclusion criteria (1 listed)
- Pregnant women between the ages of 18-45 who had a planned cesarean section and approved to participate in the study and to apply spinal anesthesia
Key exclusion criteria (1 listed)
- Patients with Preeclampsia, Eclampsia, HELLP syndrome
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 |
|---|---|---|
| Right Jugular Vein Collapsibility IndexUltrasonography will be used to evaluate the diameter of the jugular vein (minimum and maximum values) and carotid diameter. The jugular vein collapsibility index will be measured by the anesthesiologist using non-invasive ultrasonography. Jugular vein collapsibility index will be calculated using the measured diameters. | Diagnostic test | – |
Primary outcome
Prediction of hypotension
Time frame: 15 min
To evaluate the ability of the jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) to predict post spinal hypotension in cesarean section surgeries.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications and Regional Anesthesia Morbidity, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of hypotension (time frame: 15 min). 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 3 Dec 2025.