RecruitingNot Applicable

Predictive Value of ONSD and NIRS for PDPH

Turkey (Türkiye)44 participantsStarted 2026-06-19

Plain-language summary

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.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perioperative Optic Nerve Sheath Diameter (ONSD) Changes

Timeframe: Baseline (before spinal anesthesia), 10 minutes after spinal anesthesia, end of surgery, and 24 hours postoperatively

Trial details

NCT IDNCT07729449

SponsorOrdu University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-14

View on ClinicalTrials.gov More Post-Dural Puncture Headache trials