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.: PACTR201802002761404 Date of Approval: 13/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pre-operative tranexemic acid versus eethamsylate in reducing blood loss during cesarean section
Official scientific title Pre-operative tranexemic acid versus ethamsylate in reducing blood loss during cesarean section
Brief summary describing the background and objectives of the trial 2 groups one given tranexemic acid and the other given ethamsylate 20 minutes before elective cesarean section. Blood Loss is measured by the difference between pre-operative hemoglobin level and post-operative hemoglobin level
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Decreasing blood loss,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2017
Actual trial start date 01/12/2017
Anticipated date of last follow up 15/01/2018
Actual Last follow-up date 15/01/2018
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 180
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tranexemic acid group 2 ampoules of tranexemic acid Once Injection given 20 minutes before cesarean section 60
Experimental Group Ethamsylate group 2 ampoules of ethamsylate Once 20 minutes before cesarean section 60
Control Group Placebo group 2 ampoules of distilled water Once 20 minutes before cesarean section 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women undergoing elective cesarean section except those with placenta Previa Emergency cesarean section Placenta previa Any contraindications or hypersensitivity to any of the treatments 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 01/11/2017 Airforce specialized Hospital
Ethics Committee Address
Street address City Postal code Country
Elteseen (ninety) street Cairo Not available Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of blood loss Measuring preoperative and postoperative hemoglobin 24 hours after cesarean section
Secondary Outcome Need for blood transfusion By estimation of blood loss
Secondary Outcome Percentage of postpartum hemorrhage By estimation of blood loss
Secondary Outcome Need for further interventions to combat postpartum hemorrhage Estimation of cases that needed further interventions to combat postpartum hemorrhage in first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
October 6th University Central axis Giza Not available Egypt
Al-Galaa teaching Hospital Downtown Cairo Not available Egypt
Airforce specialized Hospital Elteseen (ninety) street Cairo Not available Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Airforce specialized Hospital Elteseen (ninety) street Cairo Not available Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Airforce specialized Hospital Elteseen (ninety) street Cairo Not available Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
October 6th University Central axis Giza Not available Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Torky haithamtorky@yahoo.com +201001230161 Central Axis
City Postal code Country Position/Affiliation
Giza Egypt Ocotber 6th University
Role Name Email Phone Street address
Public Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
Giza Not available Egypt October 6th University
Role Name Email Phone Street address
Scientific Enquiries Haitham Torky haithamtorky@yahoo.com +201001230161 Central axis
City Postal code Country Position/Affiliation
Giza Not available Egypt October 6th University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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