Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:53 AM
Study NCT ID:
NCT07360756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2025-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic ONSD as a Predictor of PDPH in Spinal Anesthesia for Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015331', 'term': 'Cohort Studies'}], 'ancestors': [{'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-17', 'studyFirstSubmitDate': '2025-12-26', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal Delta ONSD cut-off value for predicting PDPH', 'timeFrame': '72 hours post-spinal.', 'description': 'To determine the numerical value of the change in Optic Nerve Sheath Diameter (Delta ONSD = ONSD\\<sub\\>pre\\</sub\\> - ONSD\\<sub\\>post\\</sub\\>) that best predicts the development of PDPH.'}], 'secondaryOutcomes': [{'measure': 'Post-Dural Puncture Headache (PDPH)', 'timeFrame': '72h.', 'description': 'To assess the intensity of headache pain. By Numeric Rating Scale (NRS):\n\n0 (no pain) to 10 (worst imaginable pain).'}, {'measure': 'The Need for Epidural Blood Patch (EBP)', 'timeFrame': '72 hour', 'description': 'The % of patients requiring an Epidural Blood Patch will de determined'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-Dural Puncture Headache', 'Optic Nerve Sheath Diameter'], 'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'The Optic Nerve Sheath Diameter (ONSD), measured non-invasively by bedside ultrasound, is a well-established surrogate for intracranial pressure (ICP), as the optic nerve sheath is continuous with the intracranial dura mater and its subarachnoid space is filled with cerebrospinal fluid (CSF). While ONSD is typically used to detect elevated ICP (with a cut-off often \\> 5.0-5.7 mm for ICP \\> 20 mmHg), studies investigating PDPH have paradoxically shown a reduction in ONSD post-spinal anesthesia, correlating with the state of intracranial hypotension.\n\nPrevious research has demonstrated that a lower ONSD or a significant decrease in ONSD values 24 hours post-puncture is associated with PDPH development. A study determined that an ONSD at 24 hours of less than 0.40 cm was the best predictor for PDPH. Our study aims to specifically investigate the utility of the immediate change in ONSD to offer a bedside, real-time assessment of risk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Target Population:\n\nThe target population consists of adult female parturients who are medically eligible for spinal anesthesia and are undergoing elective cesarean delivery in a hospital setting.\n\nSource Population:\n\nThe source population is defined as all consecutive adult female patients (aged 18-45 years, ASA II-III) who are admitted to Benha University Hospitals for an elective cesarean section during the study enrollment period (December 2025 - June 2026) and who meet the eligibility criteria.\n\nStudy Sample (Final Cohort):\n\nThe study sample will comprise 150 consenting patients drawn consecutively from the source population, forming a single observational cohort. These participants will undergo standardized spinal anesthesia and serial Optic Nerve Sheath Diameter (ONSD) measurements, with follow-up for Post-Dural Puncture Headache development over 72 hours.', 'genderDescription': 'Cesarean Section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patients, aged 18-45 years\n* ASA(American Society of Anesthesiologists) physical status II or III\n* Scheduled for elective cesarean section\n* Undergoing surgery under standardized spinal anesthesia\n\nExclusion Criteria:\n\n* Pre-existing headache disorders (e.g., migraine, chronic tension-type headache)\n* Known ophthalmic conditions (e.g., optic neuropathy, glaucoma)\n* Inability to cooperate with ONSD(Optic Nerve Sheath Diameter) ultrasound measurements or follow-up\n* Allergy to local anesthetics\n* Emergency cesarean section\n* Contraindications to spinal anesthesia:\n\n * Coagulopathy\n * Infection at the puncture site\n* Preexisting hypertension on medication\n* Pre-eclampsia with severe features (suggested for separate study)\n* Known cardiac disease with hemodynamic instability\n* Allergy to study drugs\n* Fetal distress or non-reassuring cardiotocography (CTG)\n* Body Mass Index (BMI) \\>40 kg/m²\n* Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07360756', 'briefTitle': 'Ultrasonographic ONSD as a Predictor of PDPH in Spinal Anesthesia for Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Early Prediction of Post-Dural Puncture Headache Using Ultrasound-Measured Optic Nerve Sheath Diameter in Cesarean Section Patients: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'RC. 1.12.2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Cohort (Single Cohort)', 'description': 'This study comprises a single, prospectively enrolled cohort of 150 adult female patients (ASA physical status II-III) scheduled for elective cesarean section under standardized spinal anesthesia. All participants receive the same planned intervention (spinal anesthesia for surgery) and undergo the same standardized measurement protocol for Optic Nerve Sheath Diameter (ONSD). Within this cohort, participants are naturally divided by outcome during follow-up into two groups for analytical purposes:\n\nPDPH-Positive Subgroup: Patients who develop Post-Dural Puncture Headache (PDPH) within 72 hours, as diagnosed using the International Classification of Headache Disorders (ICHD-3) criteria.\n\nPDPH-Negative Subgroup: Patients who do not develop PDPH within the follow-up period.', 'interventionNames': ['Procedure: Study Cohort (Single Cohort)']}], 'interventions': [{'name': 'Study Cohort (Single Cohort)', 'type': 'PROCEDURE', 'description': 'This study comprises a single, prospectively enrolled cohort of 150 adult female patients (ASA physical status II-III) scheduled for elective cesarean section under standardized spinal anesthesia. All participants receive the same planned intervention (spinal anesthesia for surgery) and undergo the same standardized measurement protocol for Optic Nerve Sheath Diameter (ONSD). Within this cohort, participants are naturally divided by outcome during follow-up into two groups for analytical purposes:\n\nPDPH-Positive Subgroup: Patients who develop Post-Dural Puncture Headache (PDPH) within 72 hours, as diagnosed using the International Classification of Headache Disorders (ICHD-3) criteria.\n\nPDPH-Negative Subgroup: Patients who do not develop PDPH within the follow-up period.', 'armGroupLabels': ['Study Cohort (Single Cohort)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'state': 'Egypt', 'country': 'Egypt', 'contacts': [{'name': 'Neveen A. Kohaf, PhD', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '01060383012'}, {'name': 'Hany Baumy, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Al-Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Neveen A Kohaf, Ph.D', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '+201060383012'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Data could be shared upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benha University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Neveen Abd El Maksoad Kohaf', 'investigatorAffiliation': 'Al-Azhar University'}}}}