Cesarean Section ComplicationsNCT07360756
Ultrasonographic ONSD as a Predictor of PDPH in Spinal Anesthesia for Cesarean Delivery
An observational study of Cesarean Section Complications, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Study Cohort (Single Cohort)
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Target Population: The target population consists of adult female parturients who are medically eligible for spinal anesthesia and are undergoing elective cesarean delivery in a hospital setting. Source Population: The 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. Study Sample (Final Cohort): The 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.
Who may be able to join
- Adult female patients, aged 18-45 years
- ASA(American Society of Anesthesiologists) physical status II or III
- Scheduled for elective cesarean section
- Undergoing surgery under standardized spinal anesthesia
Who cannot join
- Pre-existing headache disorders (e.g., migraine, chronic tension-type headache)
- Known ophthalmic conditions (e.g., optic neuropathy, glaucoma)
- Inability to cooperate with ONSD(Optic Nerve Sheath Diameter) ultrasound measurements or follow-up
- Allergy to local anesthetics
- Emergency cesarean section
- Contraindications to spinal anesthesia:
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- Coagulopathy
- Infection at the puncture site
- Preexisting hypertension on medication
- Pre-eclampsia with severe features (suggested for separate study)
- Known cardiac disease with hemodynamic instability
- Allergy to study drugs
- Fetal distress or non-reassuring cardiotocography (CTG)
- Body Mass Index (BMI) >40 kg/m²
- Refusal to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Azhar University
Cairo, Egypt, 11865
Neveen A. Kohaf, PhD, 01060383012, nevenabdo@azhar.edu.eg
Hany Baumy, M.D
About this study
Official title: Early Prediction of Post-Dural Puncture Headache Using Ultrasound-Measured Optic Nerve Sheath Diameter in Cesarean Section Patients: A Prospective Observational Study
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.
Previous 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.
- Conditions
- Cesarean Section Complications
- Being tested
- Study Cohort (Single Cohort)
- Keywords
- Post-Dural Puncture Headache, Optic Nerve Sheath Diameter
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Cohort (Single Cohort)Procedure or surgery
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:
PDPH-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.
PDPH-Negative Subgroup: Patients who do not develop PDPH within the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort (Single Cohort) | 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:
PDPH-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.
PDPH-Negative Subgroup: Patients who do not develop PDPH within the follow-up period. Receives: Procedure: Study Cohort (Single Cohort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Delta ONSD cut-off value for predicting PDPH
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.
Measured: 72 hours post-spinal.
Secondary outcomes (2)
Post-Dural Puncture Headache (PDPH)
To assess the intensity of headache pain. By Numeric Rating Scale (NRS):
0 (no pain) to 10 (worst imaginable pain).
Measured: 72h.
The Need for Epidural Blood Patch (EBP)
The % of patients requiring an Epidural Blood Patch will de determined
Measured: 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360756
- Sponsor's protocol ID
- RC. 1.12.2025
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data could be shared upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Post-Dural Puncture Headache Using Ultrasound-Measured Optic Nerve Sheath Diameter in Cesarean Section Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07360756
- Acronym / sponsor ID
- RC. 1.12.2025
- Conditions
- Cesarean Section Complications
- Keywords
- Post-Dural Puncture Headache, Optic Nerve Sheath Diameter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Previous 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort (Single Cohort) | – | Procedure: Study Cohort (Single Cohort)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: PDPH-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. PDPH-Negative Subgroup: Patients who do not develop PDPH within the follow-up period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Target Population: The target population consists of adult female parturients who are medically eligible for spinal anesthesia and are undergoing elective cesarean delivery in a hospital setting. Source Population: The 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. Study Sample (Final Cohort): The 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.
Key inclusion criteria (4 listed)
- Adult female patients, aged 18-45 years
- ASA(American Society of Anesthesiologists) physical status II or III
- Scheduled for elective cesarean section
- Undergoing surgery under standardized spinal anesthesia
Key exclusion criteria (15 listed)
- Pre-existing headache disorders (e.g., migraine, chronic tension-type headache)
- Known ophthalmic conditions (e.g., optic neuropathy, glaucoma)
- Inability to cooperate with ONSD(Optic Nerve Sheath Diameter) ultrasound measurements or follow-up
- Allergy to local anesthetics
- Emergency cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Cohort (Single Cohort)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: PDPH-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. PDPH-Negative Subgroup: Patients who do not develop PDPH within the follow-up period. | Procedure or surgery | Study Cohort (Single Cohort) |
Primary outcome
Optimal Delta ONSD cut-off value for predicting PDPH
Time frame: 72 hours post-spinal.
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.
2 secondary outcomes
Post-Dural Puncture Headache (PDPH)
Time frame: 72h.
The Need for Epidural Blood Patch (EBP)
Time frame: 72 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes. Data could be shared upon a reasonable request from the corresponding author
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neveen A Kohaf, Ph.D (+201060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Delta ONSD cut-off value for predicting PDPH (time frame: 72 hours post-spinal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.