Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607789796937 Date of Registration: 23/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Post-Dural Puncture Headache After Spinal Anesthesia for Cesarean Delivery
Official scientific title Incidence of Post-Dural Puncture Headache After Spinal Anesthesia for Cesarean Delivery: A Prospective Study in Port Said, Egypt
Brief summary describing the background and objectives of the trial Background: Spinal anesthesia is a common and effective method used for various surgical procedures. This study aims to evaluate the incidence and clinical characteristics of Post-Dural Puncture Headache (PDPH) among women undergoing Cesarean section under spinal anesthesia at healthcare facilities in Port Said, Egypt. Method: A descriptive prospective study design had conducted at Al-Salam Hospital and Al-Yahat Hospital, affiliated with the Egypt Healthcare Authority, in Port Said city, involving 200 women who underwent spinal anesthesia for cesarean sections. Data had collected using a structured questionnaire and patients' medical records.
Type of trial Observational
Acronym (If the trial has an acronym then please provide) PDPH
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Post-Dural Puncture Headache
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 06/04/2026
Actual trial start date 06/04/2026
Anticipated date of last follow up 06/06/2026
Actual Last follow-up date 06/06/2026
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Spinal Anesthesia for Cesarean Delivery Spinal Anesthesia as per hospital protocol two-month period, starting from April Standard spinal anesthesia administered for patients undergoing elective or emergency Cesarean delivery, followed by prospective monitoring for the incidence of post-dural puncture headache. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study included women aged between 19 and 40 years with a gestational age of ≥ 37 weeks (full-term pregnancy), who were classified as physical status ASA I or II according to the American Society of Anesthesiologists. Additionally, participants had a height range between 130 cm and 180 cm to ensure anatomical consistency for spinal landmarks. Women were excluded if they had pre-existing neurological disorders or chronic migraines, as well as any contraindications to spinal anesthesia such as coagulation disorders or localized infection at the puncture site. Furthermore, patients diagnosed with pregnancy-induced hypertension or eclampsia were excluded to avoid potential confounding effects on headache-related outcomes. Adult: 18 Year(s)-44 Year(s) 19 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/04/2026 Port Said University Research Ethics Committee of the Faculty of Nursing
Ethics Committee Address
Street address City Postal code Country
Orabi and El Etihad Street Port Said 42515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary aim of this study is to evaluate the incidence of post-dural puncture headache after spinal anesthesia for cesarean delivery in Port Said, Egypt. Within the first seven postoperative days after spinal anesthesia, with daily assessment during hospitalization and telephone follow-up for participants discharged before postoperative day 7.
Secondary Outcome • Determine the incidence rate of Post-Dural Puncture Headache among the study cohort following spinal anesthesia for Cesarean delivery. • Assess the onset and duration of headache symptoms to understand the typical clinical progression within this specific population. • Identify potential risk factors associated with the occurrence of PDPH, such as needle gauge, number of puncture attempts, or maternal characteristics. • Evaluate the severity of pain using a validated scale (such as the Visual Analog Scale) and its impact on the mother's ability to care for her newborn. • Document current management strategies used for PDPH relief and their perceived effectiveness in the clinical setting. Within the first seven postoperative days after spinal anesthesia, with daily assessment during hospitalization and telephone follow-up for participants discharged before postoperative day 7.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Port Said University Al-Salam Hospital, Egypt Healthcare Authority in El-Nahda Street, Al-Sharq District. Al-Hayah Hospital Port Fuad, Egypt Healthcare Authority in Midan El-Gamea, Port Fuad. Port Said 42511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Esraa Mostafa Port Said Port Said 42515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Port Said University Port Said Port Said 42515 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Esraa Mostafa esraamostafa@nur.psu.edu.eg +2001222304435 Orabi and El Etihad
City Postal code Country Position/Affiliation
Port Said 42515 Egypt Assistant Professor of Maternity Gynecology and Obstetrics Nursing Faculty of Nursing Port Said University
Role Name Email Phone Street address
Public Enquiries Esraa Mostafa esraamostafa@nur.psu.edu.eg +2001222304435 Orabi and El Etihad Street
City Postal code Country Position/Affiliation
Port Said 42515 Egypt Assistant Professor of Maternity Gynecology and Obstetrics Nursing Faculty of Nursing Port Said University
Role Name Email Phone Street address
Scientific Enquiries Esraa Mostafa esraamostafa@nur.psu.edu.eg +2001222304435 Orabi and El Etihad Street
City Postal code Country Position/Affiliation
Port Said 42515 Egypt Assistant Professor of Maternity Gynecology and Obstetrics Nursing Faculty of Nursing Port Said University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be available Informed Consent Form Not applicaple Data sharing is not applicable for this study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.psu.edu.eg No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 To clarify the outcome measures and their assessment time points based on the reviewer’s comments. Primary Outcome, The primary aim of this study is to evaluate the incidence of post-dural puncture headache after spinal anesthesia for cesarean delivery in Port Said, Egypt. , After obtaining informed consent, participants were monitored from the point of entry into the operating theater through their first week of recovery. Data collection was conducted over a two-month pe Primary Outcome, The primary aim of this study is to evaluate the incidence of post-dural puncture headache after spinal anesthesia for cesarean delivery in Port Said, Egypt. , Within the first seven postoperative days after spinal anesthesia.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 To clarify the outcome measures and their assessment time points based on the reviewer’s comments. Primary Outcome, The primary aim of this study is to evaluate the incidence of post-dural puncture headache after spinal anesthesia for cesarean delivery in Port Said, Egypt. , Within the first seven postoperative days after spinal anesthesia. Primary Outcome, The primary aim of this study is to evaluate the incidence of post-dural puncture headache after spinal anesthesia for cesarean delivery in Port Said, Egypt. , Within the first seven postoperative days after spinal anesthesia, with daily assessment during hospitalization and telephone follow-up for participants discharged before postoperative day 7.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 To clarify the outcome measures and their assessment time points based on the reviewer’s comments. Secondary Outcome, • Determine the incidence rate of Post-Dural Puncture Headache among the study cohort following spinal anesthesia for Cesarean delivery. • Assess the onset and duration of headache symptoms to understand the typical clinical progression within this specific population. • Identify potential risk factors associated with the occurrence of PDPH, such as needle gauge, number of puncture attempts, or maternal characteristics. • Evaluate the severity of pain using a validated scale (such as the Visual Analog Scale) and its impact on the mother's ability to care for her newborn. • Document current management strategies used for PDPH relief and their perceived effectiveness in the clinical setting. , Data collection was conducted over a two-month period, starting from April. During the procedure, the anesthesia team recorded technical variables using a structured data collection sheet. Following t Secondary Outcome, • Determine the incidence rate of Post-Dural Puncture Headache among the study cohort following spinal anesthesia for Cesarean delivery. • Assess the onset and duration of headache symptoms to understand the typical clinical progression within this specific population. • Identify potential risk factors associated with the occurrence of PDPH, such as needle gauge, number of puncture attempts, or maternal characteristics. • Evaluate the severity of pain using a validated scale (such as the Visual Analog Scale) and its impact on the mother's ability to care for her newborn. • Document current management strategies used for PDPH relief and their perceived effectiveness in the clinical setting. , Within the first seven postoperative days after spinal anesthesia.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 To clarify the outcome measures and their assessment time points based on the reviewer’s comments. Secondary Outcome, • Determine the incidence rate of Post-Dural Puncture Headache among the study cohort following spinal anesthesia for Cesarean delivery. • Assess the onset and duration of headache symptoms to understand the typical clinical progression within this specific population. • Identify potential risk factors associated with the occurrence of PDPH, such as needle gauge, number of puncture attempts, or maternal characteristics. • Evaluate the severity of pain using a validated scale (such as the Visual Analog Scale) and its impact on the mother's ability to care for her newborn. • Document current management strategies used for PDPH relief and their perceived effectiveness in the clinical setting. , Within the first seven postoperative days after spinal anesthesia. Secondary Outcome, • Determine the incidence rate of Post-Dural Puncture Headache among the study cohort following spinal anesthesia for Cesarean delivery. • Assess the onset and duration of headache symptoms to understand the typical clinical progression within this specific population. • Identify potential risk factors associated with the occurrence of PDPH, such as needle gauge, number of puncture attempts, or maternal characteristics. • Evaluate the severity of pain using a validated scale (such as the Visual Analog Scale) and its impact on the mother's ability to care for her newborn. • Document current management strategies used for PDPH relief and their perceived effectiveness in the clinical setting. , Within the first seven postoperative days after spinal anesthesia, with daily assessment during hospitalization and telephone follow-up for participants discharged before postoperative day 7.
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 16/07/2026 Updated the funding source name to specify the actual funding provider as requested by the reviewer. Self Funded, Port Said, Port Said, 42515, Egypt, Self Funded, Esraa Mostafa, Port Said, Port Said, 42515, Egypt, Self Funded,