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Predictive Value of ONSD and NIRS for PDPH

Recruitingn/aAges 18 Years - 40 YearsFemaleOrdu University
NCT07729449 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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What it tests

  • Not listed
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Where

1 site
Name: Ordu University Training and Research Hospital
Ordu, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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