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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201306000554197 Date of Approval: 18/05/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intrathecal dexamethasone for preventing post dural puncture headache after spinal anesthesia for cesarean section, a double blinded randomized clinic
Official scientific title Intrathecal dexamethasone for preventing post dural puncture headache after spinal anesthesia for cesarean section, a double blinded randomized clinical trial.
Brief summary describing the background and objectives of the trial The usual practice of anesthesia today all over the world for cesarean section is spinal anesthesia which is associated with PDPH as a common complication that cause mother discomfort and prolonged length of stay, the intrathecal dexamethasone was examined to reduce the incidence of PDPH
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied post dural puncture headache,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/06/2013
Actual trial start date 20/06/2013
Anticipated date of last follow up 18/08/2013
Actual Last follow-up date 31/08/2013
Anticipated target sample size (number of participants) 99
Actual target sample size (number of participants) 99
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
7/2013 anesthesia REC
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
Parallel: different groups receive different interventions at same time during study Randomised coin tossing another provider not involved in that day Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intrathecal dexamethasone 8mg 45min Intrathecal dexamethasone during spinal naesthesia 120 Placebo
Experimental Group Intrathecal dexamethasone 4mg 45min Intrathecal dexamethasone during spinal naesthesia 120 Placebo
Control Group Intrathecal saline 2cc 45min placebo instead of dexamethasone 120 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
full term pregnant patient singleton indicated for elective section under spinal anesthesia with no history of medical importance was included pregnant patient indicated for emergency section or elective with positive history of medical importance was excluded 18 Year(s) 45 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 07/01/2013 anesthesia department
Ethics Committee Address
Street address City Postal code Country
kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt CAIRO Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post dural puncture headache day one ,three and seven
Secondary Outcome vital signs disruption every 5 minutes for 45 mintes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hassan Mohamed Ali kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt Cairo Egypt University
Primary Sponsor Cairo university kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mourad Hashim kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt Cairo Egypt
Ahmed Abdel Kader Fahmy Demerdash Street-Ain shams University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt. Cairo Egypt
Maher Fawzy Mahmoud kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo¿Egypt Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Mohamed Ali hassan364@hotmail.com +201001733687 kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt.
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia and pain management, Anesthesia department, Cairo University
Role Name Email Phone Street address
Public Enquiries Hassan Ali hassan364@hotmail.com +201001733687 kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt.
City Postal code Country Position/Affiliation
Cairo 1234 Egypt lecturer of anesthesia-Cairo university
Role Name Email Phone Street address
Scientific Enquiries Hassan Ali hassan364@hotmail.com +201001733687 kasr Elaine Street-Cairo University ¿faculty of medicine-anesthesia department--Cairo ¿Egypt.
City Postal code Country Position/Affiliation
Cairo 1234 Egypt lecturer of anesthesia-Cairo university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information