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.: PACTR202101794541918 Date of Approval: 21/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Oxytocin versus Tranexamic acid and Ethamsylate
Official scientific title Comparative Study Between Oxytocin Versus Tranexamic Acid &Ethamsylate to Reduce Blood Loss Intraoperative and Postoperative During Elective Cesarean Delivery
Brief summary describing the background and objectives of the trial To compare the effect of Oxytocin alone Versus Tranexamic acid and Ethamsylate in reduction of blood loss during elective cesarean section
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied blood loss
Purpose of the trial Prevention
Anticipated trial start date 01/04/2020
Actual trial start date 11/04/2020
Anticipated date of last follow up 01/10/2020
Actual Last follow-up date 30/11/2020
Anticipated target sample size (number of participants) 230
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oxytocin Group 5 IU 5 - 10 min Infusion Injection of the Oxytocin before the elective C-Delivery and before the skin incision 100
Experimental Group Tranexamic Acid and Ethamsylate Group 1 g of Tranexamic Acid and 250 Mg of Ethamsylate 5 - 10 min pre-operation intravenous giving of the experimental drugs and before the skin incision during C-Delivery 100
Control Group NA NA NA NA 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Pregnant females admitted for elective Cesarean Section 2-Gestational age (38 to 41 weeks) 3- Age of the participants: 20y to 40 years 4- Body Mass Index (18.5 - 29.9) 5-Singleton living fetus. 6-No medical disorders. 1 - Medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid-stimulating hormone(TSH), all of them should be within normal limits). 2 -Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal). 3 -Acute and chronic liver or kidney diseases; blood disorders, such as anemia. 4 -Allergy to Tranexamic acid or any drug used. 5 -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage. 6 - Abnormal placentae such as placenta previa and placental abruption. 7 -Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion. 8 - Patients who refused spinal anesthesia. Adult: 19 Year-44 Year 20 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 08/06/2020 Quality Education Assurance Unit. Al Azhar Faculty Of Medicine
Ethics Committee Address
Street address City Postal code Country
Nasr City Nasr City. Cairo 13111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively. 2 hours , after Cesarean Section
Secondary Outcome Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively. 24 Hours , after Cesarean Section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AL Azhar Faculty Of Medicine for Boys Elgeish Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. AbdelAzim Mohamed bab El Shaaria Street Cairo 13111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sayed Galal bab elshaarya cairo Egypt Hospital
Secondary Sponsor Shoubra General Hospital ElMostashafa street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Sayed Galal Hospitals Elgeish street cairo Egypt
Shoubra General Hospital El Mostashfa Hospital Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AbdelAzim Mohamed abdopasha@gmail.com +201003474843 Mohamed Naguib
City Postal code Country Position/Affiliation
Cairo 13111 Egypt Assistant Specialist
Role Name Email Phone Street address
Scientific Enquiries AbdelSattar Farhan drabdsattar@gmail.com +201000500747 Elgeish street
City Postal code Country Position/Affiliation
cairo 13111 Egypt Alazhar faculty of medicine
Role Name Email Phone Street address
Public Enquiries Elsayed ElDesouky elsayedeldesouky@yahoo.com +201092934978 Elgeish street
City Postal code Country Position/Affiliation
cairo 13111 Egypt AlAzhar Faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No IPD sharing according to participants request Statistical Analysis Plan,Study Protocol 6 months Patients of the study: This was a Double-blinded prospective observational controlled study. Which was done blindly for professional evaluation, started from April 2020 to October 2020, comparing the effect of pre-operative giving of Oxytocin OR tranexamic acid Ethamsylate in decreasing blood loss through and after Elective Cesarean Delivery. Methods of study:230 child bearings came to participate in the trial. And aged from 20 to 40 years. delivered by Cesarean Delivery, Gestational age of pregnancy was 38 to 41 weeks. and had a suitable history, with suitable general and local exams and accepted pregnant Doppler ultrasound and accepted laboratory results to choose whom fulfilled the inclusion criteria, whom delivered by cesarean delivery. except for the ones who had side effects to any of the drugs used in the study, Or those who had the bleeding tendency or coagulation problems. and cases of abnormal placentae. 200 childbearing women accepted to join the study, while the other 30 refused. The chosen pregnant women were randomly selected by using a simple randomization table created by a computer software program, And the selected candidates were spread out in closed opaque envelopes by the coordinator in each unit, With no contact with any of the researchers. Each group included 100 pregnant women, the first group injected with 5 IU of oxytocin IV infusion slowly 5- 10 minutes before skin incision, and the second group injected with 1 g of tranexamic acid and 250 mg of etamsylate IV slowly 5-10 minutes before skin incision. All candidates were delivered by lower segment elective cesarean section under spinal anesthesia through Pfannenstiel skin incision using a standard operative technique.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 13/12/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/12/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://clinicaltrials.gov/ct2/show/NCT04656067
Changes to trial information