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.: PACTR202102576748863 Date of Approval: 15/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title “Assessment the Role of Tranexamic Acid in Prevention of Postpartum Hemorrhage”
Official scientific title “Assessment the Role of Tranexamic Acid in Prevention of Postpartum Hemorrhage”
Brief summary describing the background and objectives of the trial Background: Postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity worldwide. It is believed that hemostatic imbalance secondary to release of tissue plasminogen activator (tPA) and subsequent hyperfibrinolysis plays a major role in PPH pathogenesis. Antifibrinolytic drugs such as tranexamic acid (TXA) are widely used in hemorrhagic conditions associated with hyperfibrinolysis. TXA reduced maternal death due to PPH and its use as a part of PPH treatment is recommended, and in recent years, a number of trials have investigated the efficacy of prophylactic use of TXA in reducing the incidence and the severity of PPH. Objective: To study the efficacy of Tranexamic acid in reducing blood loss during and after the lower segment cesarean section and reducing the risk of postpartum hemorrhage.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Haematological Disorders,Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied postpartum hemorrhage
Purpose of the trial Prevention
Anticipated trial start date 01/03/2018
Actual trial start date 01/03/2018
Anticipated date of last follow up 01/03/2019
Actual Last follow-up date 01/03/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo group placebo in the form of 20 ml of saline solution diluted in 50 ml saline solution and 10 I.U. oxytocin after delivery of placenta placebo in the form of 20 ml of saline solution diluted in 50 ml saline solution given slowly and 10 I.U. oxytocin after delivery of placenta placebo in the form of 20 ml of saline solution diluted in 50 ml saline solution given slowly with the induction of spinal anesthesia and 10 I.U. oxytocin after delivery of placenta 50 Placebo
Experimental Group study group 2 gm. of tranexamic acid (TXA) diluted in 50 ml saline solution given slowly with the induction of spinal anesthesia plus 10 I.U. oxytocin with the delivery of the baby 2 gm. of tranexamic acid (TXA) diluted in 50 ml saline solution given slowly with the induction of spinal anesthesia plus 10 I.U. oxytocin with the delivery of the baby 2 gm. of tranexamic acid (TXA) diluted in 50 ml saline solution given slowly with the induction of spinal anesthesia plus 10 I.U. oxytocin with the delivery of the baby 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Singleton pregnancy, P1-CS (previous one section after failed consent for trial of labor after CS), Term ≥ 37 weeks of gestation , Elective cesarean section, spinal anesthesia and written Informed consent. Failed spinal anesthesia (more than 2 attempts), Multiple pregnancy, Grand multipara, Placenta previa, Abruptio placentae, Polyhydraminos, Fever, Rupture of membranes, Patients on anticoagulants or antiplatelets, History of eclampsia or pre-eclampsia in current pregnancy, History of cardiovascular complications as Coronary artery disease or myocardial infarction, Repaired or unrepaired congenital heart disease, unstable arrhythmia or Congestive heart failure, or the patient had a contraindication to TXA administration as history of venous thromboembolism, active thromboembolic disease, high risk of thrombosis (e.g. factor V Leiden or protein C deficiency), allergy to TXA, Pre-existing hematuria or history of renal insufficiency Adult: 19 Year-44 Year 18 Year(s) 39 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 02/04/2018 Ain Shams University Faculty of medicine Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome of our study is the amount of blood loss during and after CS; which was estimated by calculating the blood loss using standard equations by using preoperative and 24 hours postoperative hematocrit value as follows: 1. Estimate blood volume for women 65 ml/kg. 2. Estimate the red blood cell volume (RBCV) at the preoperative hematocrit (RBCVpreop). 3. Estimate RBCV at the postoperative hematocrit (RBCVpostop), assuming normal blood volume is maintained. 4. Calculate the RBCV lost: RBCVlost = RBCVpreop – RBCVpostop 5. Blood loss = RBCV lost × 3. after placental separation till 24 hours postoperative
Secondary Outcome The secondary outcome measures were Vital signs (pulse, blood pressure, respiratory rate) during first 6 hours postoperatively and 24 hours post-operative hemoglobin and hematocrit values. Any complication that could be reported such as the need for blood transfusion or the need for any surgical measures to stop bleeding was recorded. after placental separation till 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University abbassia Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Ibrahim Sobhy Abbassia Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams University Abbassia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fahmy saad eskander Abbassia Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Sobhy mohammedsobhy16@gmail.com 00201008440715 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Walid Basuony walidbasuony@gmail.com 00201001763042 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Fahmy Saad fslatif@yahoo.com 00201001577921 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Principal Investigator Nevein Gerges nivengerges@hotmail.com 00201005282785 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
Role Name Email Phone Street address
Principal Investigator Amin Alansary aminalansary@yahoo.com 00201007962192 abbassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 12/02/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 12/02/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information