An observational study in Post Dural Puncture Headache, sponsored by Kocaeli University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Kocaeli University · Observational
Some patients develop headache after spinal anesthesia used during cesarean section. This condition is called post-dural puncture headache (PDPH). Early identification of patients at risk may improve patient care.
This study evaluates whether optic nerve sheath diameter (ONSD), measured using a non-invasive bedside ocular ultrasound technique, can help predict the development of PDPH.
Participants undergoing cesarean section with spinal anesthesia will undergo ONSD measurements at predefined perioperative time points. Participants will be followed postoperatively for the occurrence of headache.
The findings may help improve early recognition and management of PDPH.
Post-dural puncture headache (PDPH) is a common complication after spinal anesthesia, particularly in patients undergoing cesarean section. It is thought to occur due to cerebrospinal fluid leakage and decreased intracranial pressure.
Optic nerve sheath diameter (ONSD) measured by ocular ultrasound reflects changes in intracranial pressure and may help identify patients at risk for PDPH. This prospective observational study aims to evaluate the predictive value of serial ONSD measurements for the development of PDPH in patients undergoing cesarean section under spinal anesthesia.
Non-invasive bedside ultrasound measurements of ONSD will be performed at predefined perioperative time points. Participants will be followed postoperatively to assess the occurrence of headache.
The results of this study may help improve early identification of patients at risk for PDPH and enhance postoperative management.
122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.
This study's planned enrollment of 220 is above the median of 150 across 35 observational studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Kocaeli University is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of pregnant women aged 18-45 years undergoing cesarean section under spinal anesthesia at Kocaeli University Hospital. Participants who meet the eligibility criteria and provide informed consent will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo non-invasive ocular ultrasound measurement of optic nerve sheath diameter at five predefined time points: preoperatively, 10 minutes after spinal anesthesia, at the end of surgery, at postoperative 24 hours, and at postoperative 48 hours.
Association Between Optic Nerve Sheath Diameter Measurements and Post-Dural Puncture Headache
Assessment of the association between optic nerve sheath diameter measurements and the development of post-dural puncture headache.
Time frame: Within 48 hours after spinal anesthesia
Plan to share: No — Individual participant data will not be shared in order to protect participant privacy and confidentiality. Only aggregated study results will be reported in scientific publications.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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