Predictive Value of ONSD and NIRS for PDPH
Recruiting now
Conditions studied: Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
In brief
Currently, there is no reliable and effective method available in clinical practice to predict the development of PDPH. Early prediction and prevention of PDPH would reduce the incidence of postoperative complications, thereby enhancing the quality of recovery and care for both the mother and the newborn. In this study, by testing the hypothesis that ONSD changes occurring after spinal anesthesia in pregnant women scheduled for elective cesarean delivery are associated with the development of PDPH, a predictive cutoff value for ONSD will be determined to foresee this complication. As a secondary endpoint, we aimed to evaluate the monitoring of cerebral desaturation secondary to post-spinal hypotension via NIRS and to assess the clinical significance of these data in predicting the development of PDPH.
Key facts
- Study ID
- NCT07729449
- Run by
- Ordu University
- People needed
- 44
- Starts
- 2026-06-19
- Expected to finish
- 2027-06-19
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged 18-40 years,
- American Society of Anesthesiologists (ASA) physical status classification of II or III,
- Beyond 37 weeks of gestation,
- Elective cesarean delivery,
- Provided written informed consent
You may not qualify if…
- Patients undergoing emergency cesarean delivery
- Presence of preoperative anxiety [State-Trait Anxiety Inventory (STAI) - I] score > 30)
- Presence of preoperative anemia (Hemoglobin < 11 g/dL),
- History of hypertension, gestational hypertension, hyperthyroidism, or preeclampsia/eclampsia,
- Presence of fetal and/or placental anomalies,
- Known neurological, psychiatric, cardiovascular, or muscular diseases,
- Chronic headache,
- Active ocular disease or optic nerve damage,
- Allergies to local anesthetics or other medications,
- Requirement for intraoperative general anesthesia,
- Presence of contraindications to neuraxial anesthesia or conversion to intraoperative general anesthesia,
- Multiple puncture attempts during spinal anesthesia administration,
- Development of postpartum hemorrhage.
Where it is running
- Name: Ordu University Training and Research Hospital — Ordu, Altinordu, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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