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.: PACTR202107872851363 Date of Approval: 19/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Tranexamic Acid in Reducing Blood Loss During Caesarean Section
Official scientific title Prophylactic Tranexamic Acid for Reducing Intraoperative Blood Loss During Caesarean Section in Women at High risk of Postpartum Haemorrhage. A Double Blind Placebo Controlled Randomised Study
Brief summary describing the background and objectives of the trial Majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in women who were not at high risk of postpartum hemorrhage(PPH), Recent cochrane systemic review concluded that further research is needed to examine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of PPH The objective therefore is to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to caesarean delivery in women at high risk of PPH
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 Treatment: Drugs
Anticipated trial start date 24/07/2021
Actual trial start date 19/07/2021
Anticipated date of last follow up 08/11/2021
Actual Last follow-up date 28/02/2022
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tranexamic acid 1gm (given once) given over 10 minutes 1gm of tranexamic acid was mixed with 20 mls of normal saline and given over 10 minutes 100
Control Group Normal Saline 20 mls (given once) 20 mls given over 10 minutes 20 mls of normal saline was given over 10mins 10 minutes prior to surgery 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women at risk of PPH and booked for Caesarean section at ESUTH-Parklane. Uterine rupture intra-uterine fetal death history of bleeding disorders history of thrombo-embolism significant antepartum haemorrhage known allergy to tranexamic acid Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 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 21/08/2020 ESUT Teaching Hospital Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Parklane, GRA, Enugu Enugu 400102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean intra-operative blood loss during caesarean delivery and haematocrit change 48 hours postoperatively. 48 hours
Secondary Outcome need for additional uterotonics, need for blood transfusion, need for other surgical intervention for PPH (such as B-lynch procedure, or hysterectomy), incidence of postpartum maternal anaemia and occurrence of adverse effects (nausea, vomiting, thrombo-embolism, coagulopathy, etc) during the surgery. 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Enugu State University Teaching Hospital Parklane, GRA Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Kelvin Ortuanya Emeka 1 Parklane GRA Road Enugu 435001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kelvin Ortuanya Parklane, GRA Enugu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Frank Ezugwu Parklane, GRA Enugu Nigeria
George Uchenna Eleje No 49 Nnewi onitsha road Nnewi Nigeria
Ifeanyichukwu Ofor Parklane, GRA Enugu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kelvin Ortuanya ochiagha10@yahoo.com 08035006365 Parklane, GRA
City Postal code Country Position/Affiliation
Enugu Nigeria Specialist Registrar
Role Name Email Phone Street address
Scientific Enquiries George Eleje georgel21@yahoo.com 08068117444 No 49 Nnewi onitsha road
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior lecturer
Role Name Email Phone Street address
Public Enquiries Frank Ezugwu frankezugwu@yahoo.com 08033979693 Parklane, GRA
City Postal code Country Position/Affiliation
Enugu Nigeria Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, and figures) Clinical Study Report,Study Protocol Within 6 months of completing the study Public
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