PregnancyNCT07706751
Prediction of Postdural Puncture Headache
An observational study of Pregnancy and Headache After Spinal Puncture, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The primary objective of this study is to evaluate the effectiveness of inflammation index (pan-immune inflammation value, systemic immune inflammation index, and systemic inflammatory response index) values, calculated from routine pre- and post-operative blood test (hemogram) results of pregnant women undergoing… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Headache After Spinal Puncture
- How many people
- 260 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Dec 2026
- How long will I take part?
- 5 Days
- 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 cesarean section under spinal anesthesia
Who may be able to join
- . Pregnant women who are of a cognitive level capable of giving informed consent
- Pregnant women aged 18-45 who have undergone elective cesarean section
- Term (37 weeks and above) pregnant women
- Patients with an American Society of Anesthesiologists (ASA) physical status score of 2 (ASA II)
Who cannot join
- History of active infection or chronic inflammatory disease
- History of steroid or immunomodulatory drug use
- Presence of coagulopathy or hematological disorder
- Presence of preeclampsia/HELLP syndrome
- Those who received blood transfusions during and after surgery
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
Amasya University Training and Research Hospital
Amasya, 05100
About this study
Official title: The Effectiveness of Inflammatory Indices in Predicting Postdural Puncture Headache
The primary objective of this study is to evaluate the effectiveness of inflammation index (pan-immune inflammation value, systemic immune inflammation index, and systemic inflammatory response index) values, calculated from routine pre- and post-operative blood test (hemogram) results of pregnant women undergoing cesarean section under spinal anesthesia, in predicting postdural puncture headache. Significant results will allow for the early identification of the population at risk of developing PPH and the implementation of preventive measures. The secondary objectives of the study are to evaluate the effects of factors such as demographic data (age, height, weight, and body mass index) obtained from patient records and the hospital information system, number of births, blood group, infant birth weight, smoking, previous history of postdural puncture headache (PPH), or headache in general, on the development of postdural puncture headache (PPH), to determine the frequency of PPH, and to identify the symptoms accompanying PPH.
Read the detailed description
This study is a prospective observational clinical research aiming to evaluate the effectiveness of inflammation index values, calculated from routine blood tests (hemogram) performed before and after surgery in pregnant women undergoing cesarean section under spinal anesthesia, in predicting postdural puncture headache. Spinal anesthesia (SA) is the most commonly preferred regional anesthesia method in cesarean sections due to its rapid onset and effective sensory-motor blockade, but it can lead to complications that restrict maternal comfort in the postoperative period. The most frequently observed of these complications is postdural puncture headache (PPH), which is characteristically worsened in the upright position, relieved in the supine position, and develops within 5 days. PPH, usually located in the frontal or occipital region, is a clinical condition that may be accompanied by symptoms such as nausea, vomiting, weakness, tinnitus, photophobia, and neck pain. Incidence; The type of needle used varies depending on age, gender, and technical factors . The fundamental mechanism in the pathophysiology of PPH is intracranial hypotension resulting from cerebrospinal fluid (CSF) leakage and the subsequent traction in the brain tissue. Cerebral vasodilation and systemic neuroinflammatory response are also thought to contribute to this process . The physiological systemic inflammatory response observed during pregnancy plays a critical role in the maternal immune system's development of immune tolerance against the fetus and the sustainability of the pregnancy. During this process, neutrophilia, relative lymphopenia, and increased monocyte activation are particularly observed, and these immunological changes are characterized by pro-inflammatory and anti-inflammatory phases that differ according to the trimesters of pregnancy .Systemic inflammatory response has been shown to have significant effects not only on infectious processes but also on nociceptive mechanisms and tissue healing. Immune system components such as macrophages, T-lymphocytes, and mast cells, along with pro-inflammatory mediators like tumor necrosis factor (TNF), interleukin-1 (IL-1), IL-6, and IL-8, are reported to directly contribute to pain pathogenesis . In recent years, pan-immune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index have emerged as cost-effective and easily accessible next-generation biomarkers enabling holistic assessment of inflammation. These indices, calculated from complete blood count (hemogram) parameters using the formulas (neutrophil count x monocyte count x platelet count / lymphocyte count), (platelet count x neutrophil count / lymphocyte count), and (neutrophil count x monocyte count / lymphocyte count), respectively, have been proven to have high prognostic value in predicting various pathophysiological processes in extensive cohort studies . The main objective of this study, planned with the prediction that the physiological inflammatory shift during pregnancy may increase susceptibility to PPH by raising the pan-immune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values above basal levels, is; The aim of this study is to investigate the predictive value of the aforementioned inflammatory index levels in predicting PPH in pregnant women undergoing cesarean section under spinal anesthesia. Finding significant results will allow for the identification of pregnant women at high risk and the development of early treatment strategies for those predicted to be at high risk.
- Conditions
- Pregnancy, Headache After Spinal Puncture
- Keywords
- pregnancy, headache after spinal puncture, pan-immune inflammation value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with postdural puncture headache | Patients with postdural puncture headache after cesarean section | |
| Patients without postdural puncture headache | Patients without postdural puncture headache after cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive role of inflammation indices for postdural puncture headache.
- The correlation between the preoperative basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values and the development of PPH will be statistically evaluated.
- Sensitivity and specificity evaluation will be performed for basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values in those who develop PPH.
Measured: 5 days
Secondary outcomes (1)
PPH incidence
The incidence of PPH developing after postdural puncture will be investigated.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706751
- Sponsor's protocol ID
- mmk05
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical reasons within the scope of patient privacy
Publications
Bayram E, Dolgun I. Association of Preoperative Neutrophil-to-Lymphocyte Ratio With Post-Dural Puncture Headache After Cesarean Delivery. Med Sci Monit. 2026 Feb 6;32:e952396. doi: 10.12659/MSM.952396.
PubMed 41645494
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Inflammatory Indices in Predicting Postdural Puncture Headache
- ClinicalTrials.gov ID
- NCT07706751
- Acronym / sponsor ID
- mmk05
- Conditions
- Pregnancy, Headache After Spinal Puncture
- Keywords
- pregnancy, headache after spinal puncture, pan-immune inflammation value
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 16 Jul 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.
The primary objective of this study is to evaluate the effectiveness of inflammation index (pan-immune inflammation value, systemic immune inflammation index, and systemic inflammatory response index) values, calculated from routine pre- and post-operative blood test (hemogram) results of pregnant women undergoing cesarean section under spinal anesthesia, in predicting postdural puncture headache. Significant results will allow for the early identification of the population at risk of developing PPH and the implementation of preventive measures. The secondary objectives of the study are to evaluate the effects of factors such as demographic data (age, height, weight, and body mass index) obtained from patient records and the hospital information system, number of births, blood group, infant birth weight, smoking, previous history of postdural puncture headache (PPH), or headache in general, on the development of postdural puncture headache (PPH), to determine the frequency of PPH, and to identify the symptoms accompanying PPH.
Detailed description
This study is a prospective observational clinical research aiming to evaluate the effectiveness of inflammation index values, calculated from routine blood tests (hemogram) performed before and after surgery in pregnant women undergoing cesarean section under spinal anesthesia, in predicting postdural puncture headache. Spinal anesthesia (SA) is the most commonly preferred regional anesthesia method in cesarean sections due to its rapid onset and effective sensory-motor blockade, but it can lead to complications that restrict maternal comfort in the postoperative period. The most frequently observed of these complications is postdural puncture headache (PPH), which is characteristically worsened in the upright position, relieved in the supine position, and develops within 5 days. PPH, usually located in the frontal or occipital region, is a clinical condition that may be accompanied by symptoms such as nausea, vomiting, weakness, tinnitus, photophobia, and neck pain. Incidence; The type of needle used varies depending on age, gender, and technical factors . The fundamental mechanism in the pathophysiology of PPH is intracranial hypotension resulting from cerebrospinal fluid (CSF) leakage and the subsequent traction in the brain tissue. Cerebral vasodilation and systemic neuroinflammatory response are also thought to contribute to this process . The physiological systemic inflammatory response observed during pregnancy plays a critical role in the maternal immune system's development of immune tolerance against the fetus and the sustainability of the pregnancy. During this process, neutrophilia, relative lymphopenia, and increased monocyte activation are particularly observed, and these immunological changes are characterized by pro-inflammatory and anti-inflammatory phases that differ according to the trimesters of pregnancy .Systemic inflammatory response has been shown to have significant effects not only on infectious processes but also on nociceptive mechanisms and tissue healing. Immune system components such as macrophages, T-lymphocytes, and mast cells, along with pro-inflammatory mediators like tumor necrosis factor (TNF), interleukin-1 (IL-1), IL-6, and IL-8, are reported to directly contribute to pain pathogenesis . In recent years, pan-immune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index have emerged as cost-effective and easily accessible next-generation biomarkers enabling holistic assessment of inflammation. These indices, calculated from complete blood count (hemogram) parameters using the formulas (neutrophil count x monocyte count x platelet count / lymphocyte count), (platelet count x neutrophil count / lymphocyte count), and (neutrophil count x monocyte count / lymphocyte count), respectively, have been proven to have high prognostic value in predicting various pathophysiological processes in extensive cohort studies . The main objective of this study, planned with the prediction that the physiological inflammatory shift during pregnancy may increase susceptibility to PPH by raising the pan-immune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values above basal levels, is; The aim of this study is to investigate the predictive value of the aforementioned inflammatory index levels in predicting PPH in pregnant women undergoing cesarean section under spinal anesthesia. Finding significant results will allow for the identification of pregnant women at high risk and the development of early treatment strategies for those predicted to be at high risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with postdural puncture headache | – | –Patients with postdural puncture headache after cesarean section |
| Patients without postdural puncture headache | – | –Patients without postdural puncture headache after cesarean section |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing cesarean section under spinal anesthesia
Key inclusion criteria (4 listed)
- . Pregnant women who are of a cognitive level capable of giving informed consent
- Pregnant women aged 18-45 who have undergone elective cesarean section
- Term (37 weeks and above) pregnant women
- Patients with an American Society of Anesthesiologists (ASA) physical status score of 2 (ASA II)
Key exclusion criteria (5 listed)
- History of active infection or chronic inflammatory disease
- History of steroid or immunomodulatory drug use
- Presence of coagulopathy or hematological disorder
- Presence of preeclampsia/HELLP syndrome
- Those who received blood transfusions during and after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The predictive role of inflammation indices for postdural puncture headache.
Time frame: 5 days
* The correlation between the preoperative basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values and the development of PPH will be statistically evaluated. * Sensitivity and specificity evaluation will be performed for basal panimmune inflammation value, systemic immune-inflammation index, and systemic inflammatory response index values in those who develop PPH.
1 secondary outcome
PPH incidence
Time frame: 5 days
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 16 Jul 2026.
- Results publication: PubMed 41645494Bayram E, Dolgun I. Association of Preoperative Neutrophil-to-Lymphocyte Ratio With Post-Dural Puncture Headache After Cesarean Delivery. Med Sci Monit. 2026 Feb 6;32:e952396. doi: 10.12659/MSM.952396.
- Individual participant dataSharing planned: No. Ethical reasons within the scope of patient privacy
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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 Pregnancy and Headache After Spinal Puncture, run by Amasya 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 4 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 16 Jul 2026. 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 Osman O Kılınç, ass prof (+905067352859, zxgr03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive role of inflammation indices for postdural puncture headache. (time frame: 5 days). 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 NCT07706751, which also lists 1 linked publication.
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 16 Jul 2026.