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.: PACTR202208847435444 Date of Approval: 16/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFICACY OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING CAESAREAN SECTION: A RANDOMIZED DOUBLE BLIND CONTROLLED MULTICENTRE STUDY
Official scientific title EFFICACY OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING CAESAREAN SECTION: A RANDOMIZED DOUBLE BLIND CONTROLLED MULTICENTRE STUDY
Brief summary describing the background and objectives of the trial BACKGROUND: Primary postpartum haemorrhage (PPH) is a leading obstetric cause of death in Nigeria. Maternal mortality is an indicator of the health status of women of reproductive age and reflects the health system of a country. Caesarean section (CS) though a life-saving alternative to vaginal delivery in several maternity units globally, is a risk factor for PPH. Its rate has increased globally with wide variability amongst and within various countries. Tranexamic acid (TXA) is an affordable, readily available medication that has been investigated as a potentially useful complement to uterotonics which has been shown to reduce blood loss and incidence of blood transfusion in various surgeries. Routine administration of low dose TXA might be effective for reduction of blood loss during and after elective and emergency caesarean deliveries. AIM AND OBJECTIVES: The main purpose of this study is to determine the efficacy of routine administration of Tranexamic Acid (TXA) in reducing blood loss during lower segment caesarean section. METHODOLOGY: A randomized, double-blinded multicenter study in which sixty-five consenting pregnant women that were scheduled for either elective or emergency LSCS at Institute of Maternal and Child Health, Lagos State University Teaching Hospital (LASUTH) and Federal Medical Center, Ebute-Metta (FMCEB) Lagos, were randomized to get 1 g of TXA and other sixty-five were to receive Sterile water within a minutes of delivery of the fetus following routine administration of an oxytocic. Estimated blood loss from placenta delivery to two hours postpartum was based on the difference between the preoperative and postoperative hematocrit. Data was imported into Stata version 17 (StataCorp, USA) software for analysis. Descriptive statistics was done. Categorical variables were described using frequency and percentages while continuous variables were described as mean and standard deviation or median and interquartile range (IQR) if skewed.
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 REDUCING BLEEDING AT LOWER SEGMENT CESAREAN SECTION
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2021
Actual trial start date 08/02/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 142
Actual target sample size (number of participants) 130
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TRANEXAMIC ACID GROUP A SINGLE DOSE OF 1g INTRAVENOUS TRANEXAMIC ACID DURATION OF STUDY IS FOR NINE MONTH A SINGLE DOSE OF 1g INTRAVENOUS TRANEXAMIC ACID IS GIVEN OVER TWO TO THREE MINUTES WITHIN ONE MINUTE OF DELIVERY OF THE FETUS. 65
Control Group CONTROL GROUP SINGLE DOSE NINE MONTHS INTRAVENOUS INJECTION OF 10ml STERILE WATER FOR INJECTION 65 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age ≥ 18 years Patients admitted for primary or secondary caesarean section (Elective or Emergency) Gestational age of 36 to 42 weeks of gestation Singleton pregnancy Informed consent form signed History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial thrombosis (angina pectoris, myocardial infarction, stroke) Any known cardiovascular, renal, or liver disorders Autoimmune disease Sickle cell disease Severe hemorrhagic disease Planned general anesthesia Placenta previa Abruptio placentae Eclampsia, HELLP syndrome Multiple pregnancy In utero fetal death Administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery Consent not obtained Adult: 19 Year-44 Year 18 Year(s) 50 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 17/12/2020 HEALTH RESEARCH ETHICS COMMITTEE LASUTH
Ethics Committee Address
Street address City Postal code Country
1-5 OBA-AKINJOBI WAY LAGOS Lagos 21005 Nigeria
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 28/04/2021 ETHICAL COMMITTEE RESEARCH EDUCATION AND TRAINING FEDERAL MEDICAL CENTRE EBUTEMETTA
Ethics Committee Address
Street address City Postal code Country
NIGERIA RAILWAY COMPOUND PMB 1097 EBUTE METTA LAGOS Lagos 101245 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the effect of TXA (1g) on post-operative blood loss. POSTPARTUM
Primary Outcome To compare the percentage fall in post-operative haemoglobin between drug and placebo group. POSTPARTUM
Primary Outcome To assess the need for additional uterotonic agents. POSTPARTUM
Primary Outcome To assess for presence of adverse effect of intravenous TXA POSTPARTUM
Primary Outcome There was a statistically significant difference in the calculated estimated blood loss among the intervention and the placebo arm of the study (P-value < 0.0001) POSTPARTUM
Secondary Outcome The prevalence of PPH among the placebo group was four times that of the Tranexamic acid group. (P-value < 0.0001) POSTPARTUM
Secondary Outcome There was no statistically significant difference in the use of additional uterotonic, blood transfusion and adverse effect profile between the two groups. POSTPARTUM
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTRE EBUTEMETTA NIGERIA RAILWAY COMPOUND, OYINGBO LAGOS 101211 Nigeria
AYINKE HOUSE LAGOS STATE UNIVERSITY TEACHING HOSPITAL LASUTH 1-5 OBA-AKINJOBI WAY IKEJA LAGOS LAGOS 101233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ODUOLAOWOO BADMUS BABATUNDE 78 OGUNLANA STREET EGBEDA AKOWANJO LAGOS LAGOS 100276 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ODUOLAOWOO BAMUS BABTUNDE 78 OGUNLANA STREE EGBEDA LAGOS LAGOS 100276 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator BADMUS BABATUNDE ODUOLAOWOO oduolowo@gmail.com +2348060114545 78 OGUNLANA STREET EGBEDA LAGOS
City Postal code Country Position/Affiliation
LAGOS 100276 Nigeria PRINCIPAL INVESTIGATION
Role Name Email Phone Street address
Scientific Enquiries OLORUNFEMI GBENGA drgbengafemi@yahoo.co.uk +2348037835018 LAGOS UNIVERSITY TEACHING HOSPITAL LUTH IDIARABA LAGOS
City Postal code Country Position/Affiliation
LAGOS 100254 Nigeria OUTCOME ASSESSOR STATISTECIAN
Role Name Email Phone Street address
Public Enquiries MAYOWA ADEFUYE mayowaadefuye18@gmail.com +2348135886723 SAGAMU OGUN STATE
City Postal code Country Position/Affiliation
LAGOS 121102 Nigeria RESEARCH ASSISTANT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes RESULT: The mean age of participant 30.8 ± 4.76 with 84% had one or more parus experience. There was a statistically significant difference in the calculated estimated blood loss among the intervention and the placebo arm of the study (P-value < 0.0001) and the prevalence of PPH among the placebo group was four times that of the Tranexamic acid group. (P-value < 0.0001) There was no statistically significant difference in the use of additional uterotonic, blood transfusion and adverse effect profile between the two groups. CONCLUSION: Prophylactic use of intravenous Tranexamic acid as an adjunct to uterotonic at caesarean section is efficacious in reducing blood loss and preventing post-partum haemorrhage. Informed Consent Form,Statistical Analysis Plan 8 MONTHS Every proforma was given a unique number and data were collated daily and checked for completeness. Data was unblinded by connecting the code with the correct intervention arm for the purpose of analysis. Data was imported into Stata version 17 (StataCorp, USA) software for analysis. Intention to treat analysis was utilized for this analysis. Descriptive statistics was done. Categorical variables were described using frequency and percentages while continuous variables were described as mean and standard deviation or median and interquartile range (IQR) if skewed. The categorical variables were compared between the tranexamic acid and the placebo group using the Peason’s Chi-square (Fischer’s exact). Student’s ttest or Mann Whitney U were utilized to compare continuous variables among the tranexamic and placebo groups. Univariable and multivariable logistic regression was conducted with Primary post-partum haemorrhage as the outcome while the intervention group was the primary explanatory variable. Variable with P-value < 0.2 or some variables chosen a priori were included in the multivariable model. The cluster option in stata was utilized to correct for intra-class/intra-center variation. Statistically significant level was set at P-value < 0.05. Two- tailed test of hypothesis was assumed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/08/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/08/2022 Result - 15/08/2022 Result - 15/08/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information