NCT07075874

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
821

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

July 10, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

July 12, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3 days

First QC Date

July 10, 2025

Last Update Submit

July 19, 2025

Conditions

Preoperative Neutrophil-to-Lymphocyte Ratio (NLR)Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • Postdural Puncture Headache (PDPH) incidence

    The occurrence of PDPH symptoms within 10 days following spinal anesthesia in obstetric patients, as documented in medical records.

    Within 10 days postoperatively

Study Arms (2)

PDPH Group

Patients who developed postdural puncture headache (PDPH) following spinal anesthesia for cesarean section.

Other: PDPH

Non-PDPH Group

Patients who did not develop PDPH after spinal anesthesia for cesarean section

Other: PDPH

Interventions

PDPHOTHER

Observational analysis of preoperative inflammatory markers (e.g., NLR, PLR, SIRI) in relation to PDPH development following spinal anesthesia.

Non-PDPH GroupPDPH Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants were included, as the study population consisted of obstetric patients undergoing cesarean section under spinal anesthesia.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Olawin AM, Das JM. Spinal Anesthesia. 2022 Jun 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK537299/

    PMID: 30725984BACKGROUND

  • Sahin 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.

    PMID: 38850761RESULT

  • Bai 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.

    PMID: 36808350RESULT

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

ilke dolgun

CONTACT

+905555485632ilkeser2004@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. prof

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

July 12, 2025

Primary Completion

July 15, 2025

Study Completion

July 17, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations

TU(1)