Preoperative Neutrophil-to-Lymphocyte Ratio (NLR)NCT07075874
Neutrophil to Lymphocyte Ratio and Postdural Headache
An observational study of Preoperative Neutrophil-to-Lymphocyte Ratio (NLR) and Postdural Puncture Headache, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study will aim to investigate whether systemic inflammatory markers-especially the neutrophil-to-lymphocyte ratio (NLR)-obtained from preoperative complete blood counts can predict the development of post-dural puncture headache (PDPH) in obstetric patients undergoing cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preoperative Neutrophil-to-Lymphocyte Ratio (NLR), Postdural Puncture Headache
- What is being tested?
- PDPH
- How many people
- 821 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2025to 17 Jul 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of obstetric patients who underwent cesarean section under spinal anesthesia between January 2020 and December 2024 at a single tertiary center.
Who may be able to join
- Women aged 18 years or older
- Underwent elective or emergency cesarean section under spinal anesthesia
- Had complete preoperative complete blood count (CBC) data available
- No known hematological or inflammatory disease
- No intraoperative complications recorded
- Medical records accessible for postoperative follow-up regarding PDPH symptoms
Who cannot join
- Age under 18
- Absence of preoperative complete blood count data
- Presence of hematologic malignancy, active infection, autoimmune disease, or immunosuppressive therapy
- Platelet count <150,000/mm³ or INR >1.5
- Incomplete or missing medical records
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
ilke dolgun, ilkeser2004@gmail.com
ilke dolgun
About this study
Official title: Preoperative Neutrophil-to-Lymphocyte Ratio as a Predictor of Post-Dural Puncture Headache Following Cesarean Section Under Spinal Anesthesia
This study will aim to investigate whether systemic inflammatory markers-especially the neutrophil-to-lymphocyte ratio (NLR)-obtained from preoperative complete blood counts can predict the development of post-dural puncture headache (PDPH) in obstetric patients undergoing cesarean section under spinal anesthesia.
- Being tested
- PDPH
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDPHOther
Observational analysis of preoperative inflammatory markers (e.g., NLR, PLR, SIRI) in relation to PDPH development following spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| PDPH Group | Patients who developed postdural puncture headache (PDPH) following spinal anesthesia for cesarean section. Receives: Other: PDPH | |
| Non-PDPH Group | Patients who did not develop PDPH after spinal anesthesia for cesarean section Receives: Other: PDPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postdural Puncture Headache (PDPH) incidence
The occurrence of PDPH symptoms within 10 days following spinal anesthesia in obstetric patients, as documented in medical records.
Measured: Within 10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start12 Jul 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion17 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preoperative Neutrophil-to-Lymphocyte Ratio (NLR)Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 821 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075874
- Sponsor's protocol ID
- NLR-PDPH ERKAN
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olawin AM, Das JM. Spinal Anesthesia. 2022 Jun 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537299/
PubMed 30725984Sahin R, Tanacan A, Serbetci H, Agaoglu Z, Haksever M, Kara O, Sahin D. The Association of Systemic Immune-Inflammation Index (SII), Systemic Immune-Response Index (SIRI), and Neutrophil-to-Lymphocyte Ratio (NLR) with Cesarean Scar Pregnancy (CSP). J Reprod Immunol. 2024 Aug;164:104275. doi: 10.1016/j.jri.2024.104275. Epub 2024 Jun 4.
PubMed 38850761Bai YY, Xi Y, Yin BB, Zhang JH, Chen F, Zhu B. Reference intervals of systemic immune-inflammation index, neutrophil-to-lymphocyte ratio, lymphocyte-to-monocyte ratio, and platelet-to-lymphocyte ratio during normal pregnancy in China. Eur Rev Med Pharmacol Sci. 2023 Feb;27(3):1033-1044. doi: 10.26355/eurrev_202302_31199.
PubMed 36808350
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Neutrophil-to-Lymphocyte Ratio as a Predictor of Post-Dural Puncture Headache Following Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07075874
- Acronym / sponsor ID
- NLR-PDPH ERKAN
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 821 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 12 Jul 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 17 Jul 2025 (estimated)
- First posted
- 20 Jul 2025 (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.
This study will aim to investigate whether systemic inflammatory markers-especially the neutrophil-to-lymphocyte ratio (NLR)-obtained from preoperative complete blood counts can predict the development of post-dural puncture headache (PDPH) in obstetric patients undergoing cesarean section under spinal anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDPH Group | – | Other: PDPHPatients who developed postdural puncture headache (PDPH) following spinal anesthesia for cesarean section. |
| Non-PDPH Group | – | Other: PDPHPatients who did not develop PDPH after spinal anesthesia for cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of obstetric patients who underwent cesarean section under spinal anesthesia between January 2020 and December 2024 at a single tertiary center.
Key inclusion criteria (6 listed)
- Women aged 18 years or older
- Underwent elective or emergency cesarean section under spinal anesthesia
- Had complete preoperative complete blood count (CBC) data available
- No known hematological or inflammatory disease
- No intraoperative complications recorded
Key exclusion criteria (5 listed)
- Age under 18
- Absence of preoperative complete blood count data
- Presence of hematologic malignancy, active infection, autoimmune disease, or immunosuppressive therapy
- Platelet count <150,000/mm³ or INR >1.5
- Incomplete or missing medical records
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 |
|---|---|---|
| PDPHObservational analysis of preoperative inflammatory markers (e.g., NLR, PLR, SIRI) in relation to PDPH development following spinal anesthesia. | Other | Non-PDPH Group, PDPH Group |
Primary outcome
Postdural Puncture Headache (PDPH) incidence
Time frame: Within 10 days postoperatively
The occurrence of PDPH symptoms within 10 days following spinal anesthesia in obstetric patients, as documented in medical records.
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 24 Jul 2025.
- Background: PubMed 30725984Olawin AM, Das JM. Spinal Anesthesia. 2022 Jun 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537299/
- Results publication: PubMed 38850761Sahin R, Tanacan A, Serbetci H, Agaoglu Z, Haksever M, Kara O, Sahin D. The Association of Systemic Immune-Inflammation Index (SII), Systemic Immune-Response Index (SIRI), and Neutrophil-to-Lymphocyte Ratio (NLR) with Cesarean Scar Pregnancy (CSP). J Reprod Immunol. 2024 Aug;164:104275. doi: 10.1016/j.jri.2024.104275. Epub 2024 Jun 4.
- Results publication: PubMed 36808350Bai YY, Xi Y, Yin BB, Zhang JH, Chen F, Zhu B. Reference intervals of systemic immune-inflammation index, neutrophil-to-lymphocyte ratio, lymphocyte-to-monocyte ratio, and platelet-to-lymphocyte ratio during normal pregnancy in China. Eur Rev Med Pharmacol Sci. 2023 Feb;27(3):1033-1044. doi: 10.26355/eurrev_202302_31199.
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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.
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 Preoperative Neutrophil-to-Lymphocyte Ratio (NLR) and Postdural Puncture Headache, run by Istinye University 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Jul 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?
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 ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postdural Puncture Headache (PDPH) incidence (time frame: Within 10 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075874, which also lists 3 linked publications.
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 24 Jul 2025.