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.: PACTR201601001397193 Date of Approval: 21/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ondasterone during spinal anathesia for elective caeserian section
Official scientific title the effect of ondasterone versus placebo in reduction of hypotension during spinal anathesia for elective cesarean section:a prospective rando mixes trial
Brief summary describing the background and objectives of the trial Hypotension is a common side effect of spinal anathesia. The objective of our study is to evaluate the efficacy of ondasterone to reducing hypotension ,bradycardia during spinal anathesia for elective caeserian section as well nausea and vomiting
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology,Surgery
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/12/2015
Actual trial start date 21/12/2015
Anticipated date of last follow up 21/01/2016
Actual Last follow-up date 21/01/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 110
Recruitment status 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 randomization using table crated by computer soft ware programe sealed opaque envelope Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ondasterone 4mg 2 hours Iv saline 10 min prior to spinal anaesthesia ffor elective cs 50 Placebo
Experimental Group ondasterone 4mg iv 5 min before spinal anathesia 2 h ondasterone during spinal anathesia for elective cesarean section 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Elective cs Hypersensitivity to ondasterone Contraindicated spinal anathesia 18 Year(s) 38 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 06/12/2015 our local hospital ethical committee
Ethics Committee Address
Street address City Postal code Country
yassin abd elghafar shibin elkom 32465 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pulse.blood presume. oxygen saturation.nausea and vomiting Base line.5 min.20 min.every 15 min till the end of the opration
Secondary Outcome vasopressin dose nausea and vomiting Base line and every 15 min till the end of the operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of obstetrics and gynecology.faculty of medicinemenoufia university yassin abd elghafar street shibin elkom 32465 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufia university shibin elkom shibin elkom 32465 Egypt University
COLLABORATORS
Name Street address City Postal code Country
nabih elkhouly yassin abd elghafar street shibin elkom 32465 Egypt
ashraf meleegy yassin abd elghafar street shibin elkom 32465 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32465 Egypt lecturer of obstetrics and gynecology.faculty of medicine.menoufia university
Role Name Email Phone Street address
Public Enquiries nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32465 Egypt lecturer of obstetrics and gynecology department.Faculty of medicine.menoufia university
Role Name Email Phone Street address
Scientific Enquiries nabih elkhouly nabih.elkhouly@yahoo.com 01060868443 yassin abd elghafar
City Postal code Country Position/Affiliation
shibin elkom 32645 Egypt lecturer of obstetrics and gynecology department.Faculty of medicine.menoufia university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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