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.: PACTR2010010001783449 Date of Approval: 07/12/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The use of three methods for Cesarean delivery
Official scientific title A Randomized Comparison of Three Neuraxial Anesthetic Techniques for Elective Cesarean Section
Brief summary describing the background and objectives of the trial The comparison of three types of neuroxial anesthesia in cesarean delivery in pregnant women
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Elective Cesarean Section,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2010
Actual trial start date
Anticipated date of last follow up 02/01/2011
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hyperbaric bupivacaine mixed with Fentanyl 2ml .5% hyperbaric bupivacaine mixed with fentanyl 20ug intrathecally once Hyperbaric bupivacaine mixed with Fentanyl 30
Experimental Group Hyperbaric bupivacaine mixed with Fentanyl intrathecally followed by routine sequential epidural inj 1ml .5% hyperbaric bupivacaine mixed with Fentanyl 20 ug intrathecally followed by routine sequential epidural injection of 10ml .5% plain bupivacaine through the epidural catheter once Hyperbaric bupivacaine mixed with Fentanyl intrathecally followed by routine sequential epidural injection of plain bupivacaine through the epidural catheter 30
Control Group Control/Comparison 15ml .5% bupivacaine and fentanly 100ug epidurally 15ml .5% bupivacaine and fentanly 100ug epidurally 15ml .5% bupivacaine and fentanly 100ug epidurally 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant female undergoing elective caesarean section and wishes to be conscious any contraindication to regional anesthesia, sepsis, coagulopathy 18 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 02/11/2009 Ethical Committee of Tanta University
Ethics Committee Address
Street address City Postal code Country
El-guish Street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intra Operative pain intre operative period
Primary Outcome degree of muscle relaxation intra-operative period
Primary Outcome occurence of hypotension, nausea and vomiting intra-operative period
Secondary Outcome post operative pain post-operative period
Secondary Outcome Neonatal score for delivered babies post operative period
Secondary Outcome recovery of motor weakness post operative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gynacology Dept, University Hospital El-guish Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University El-Guish Street Tanta Egypt
Tanta University El-Guish Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University El-guish Street Tanta Egypt Hospital
Primary Sponsor Tanta University El-guish Street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Yasser Mohamed Amr Elmahala Elkobra Elmahala Elkobra Egypt
Yasser Mohamed Amr Elmahala Elkobra Elmahala Elkobra Egypt
Ayman Salah Al-dent Abdelsalam Saeeed Street Tanta Egypt
Ayman Salah Al-dent Abdelsalam Saeeed Street Tanta Egypt
Wail E Messbah Elstaad Street Tanta Egypt
Wail E Messbah Elstaad Street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayman Yousef ayman.yousef@rocketmail.com 0020103497767 17 El-emam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Anesthesiology
Role Name Email Phone Street address
Public Enquiries Ayman Yousef ayman.yousef@rocketmail.com 0020103497767 17 El-emam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Anesthesiology
Role Name Email Phone Street address
Scientific Enquiries Ayman Yousef ayman.yousef@rocketmail.com 0020103497767 17 El-emam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Anesthesiology
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