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.: PACTR202208859856197 Date of Approval: 10/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Two Different Doses of Tranexamic Acid for reduction of Perioperative Blood Loss in Cesarean Section: a randomized controlled study
Official scientific title Two Different Doses of Tranexamic Acid for reduction of Perioperative Blood Loss in Cesarean Section: a randomized controlled study
Brief summary describing the background and objectives of the trial Post-partum haemorrhage (PPH) is a major complication after both vaginal and caesarean delivery worldwide which contributes substantially to maternal mortality and near misses. Each year, about 1–2 % of mothers with PPH die, with an average interval of about 2–4 h from onset of PPH to death. There are four causes of PPH: uterine atony, trauma to the birth passage, retained placental tissue or membranes and coagulopathies such as DIC. Use of antifibrinolytic agent such as tranexamic acid (TXA), however, avoids both the hazards of blood transfusion as also the long-term side effects of hysterectomy. In the last decade, there has been an explosion of interest in the utility of tranexamic acid (TA) in reducing bleeding, fuelled, in particular, by the publication of CRASH-2 the largest trauma trial ever conducted. The WOMAN study, is a large, pragmatic, randomly assigned, double-blind, placebo-controlled trial designed to determine the effect of early administration of TXA on mortality, hysterectomy and other morbidities (surgical interventions, blood transfusion, risk of non-fatal vascular events) in women with clinically diagnosed PPH. While the role of tranexamic acid is well established in the management of major bleeding, the exact dose is not accurately determined and usually a dose of 1 gm is used that sometimes may be followed of another doe either one shot or infusion over 8 hrs. The aim of this study is to assess the efficacy of two different doses of tranexamic acid for the reduction of perioperative blood loss in cesarean section.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/08/2022
Actual trial start date
Anticipated date of last follow up 20/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 134
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control group 10 mg/Kg IV of tranexamic acid infusion over 10 min 10 mg/Kg IV of tranexamic acid will be given over 10 min 67 Active-Treatment of Control Group
Experimental Group study group 20 mg/Kg IV of tranexamic acid 10 min infusion 20 mg/Kg IV of tranexamic acid will be given over 10 min 67
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Age from 18- 45 years. 2) Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations). 3) term with singleton uncomplicated pregnancies. 4) Body mass index of at most 40 kg/m2. 1) Parturient with peri-partum disorders as DM, HTN, cardiac diseases, Sickle cell disease or bleeding disorders History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis. 2) Known case of coagulation disorders. 3) Severe anemia. 4) Allergy to TXA. 5) Severe medical and surgical complications involving the heart, liver, kidney, brain, and blood disorder. 6) Abnormal placenta such as placenta previa and placental abruption. 7) Pregnancy related complication like severe preeclampsia, 8) Pregnancy with <37 weeks gestational age. 9) Woman on anticoagulant therapy during the week 10) Refusal to participate in the study Adult: 19 Year-44 Year 18 Year(s) 45 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 19/07/2022 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Amount pf perioperative blood loss as mentioned before 2. Change in hemoglobin level in gm measured after 48 hrs 48 hours after delivery
Secondary Outcome 3. Need for vasopressors to maintain blood pressure within accepted level 4. Incidence of severe PPH, defined by blood loss ≥1000 mL. 5. Incidence of nausea, vomiting and thrombosis during delivery and within 24 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road, kilo 4.5 ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
omima tharwat taha ring road kilo 4.5 ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shymaa Ahmed Dahshan ring road kilo 4.5 ismailia 41522 Egypt
Ahmed Mohammed AbdElrahman Elewa ring road kilo 4.5 ismailia 41522 Egypt
omima tharwat taha ring road kilo 4.5 ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed abdelrahman ahmedabdelrahman@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt assistant professor suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt assistant professor suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing is applicable upon request and after approval of the research ethics committee Study Protocol after completion of the study after approval of the research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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