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.: PACTR202312820804233 Date of Approval: 14/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study of efficacy and safety of tranexamic acid versus ethamsylate on Caesarean section blood loss at Federal Medical Centre, Owo: randomized controlled trial
Official scientific title Comparative study of efficacy and safety of tranexamic acid versus ethamsylate on Caesarean section blood loss at Federal Medical Centre, Owo: randomized controlled trial
Brief summary describing the background and objectives of the trial Caesarean section is becoming more popular and acceptable in developing countries. Postpartum haemorrhage is one of the commonest complications of Caesarean section despite the use of oxytocics. The use of haemostatic agents may be of benefit in further reducing this risk. The objectives are; To determine the efficacy and safety of Tranexamic acid versus Ethamsylate on blood loss in women undergoing Caesarean section at Federal Medical Centre, Owo. To determine and compare the effect of tranexamic acid versus ethamsylate on the amount of blood loss during Caesarean section. To determine and compare the change in haemoglobin level after Caesarean section following administration of tranexamic acid versus ethamsylate.
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 01/12/2023
Actual trial start date
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study 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
Experimental Group Tranexamic acid 1 gram 30 minutes before Caesarean section Administration of 1gram Tranexamic acid by intravenous push 30 minutes before skin incision 32
Control Group Ethamsylate 1 gram 30 minutes before Caesarean section Administration of 1 gram Ethamsylate 30 minutes before skin incision 32 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Women within the ages of 18 to 35year ii. No contraindication for spinal anaesthesia iii. American Society of Anesthesiologists’ physical status 1 and 11 iv. Women who give written informed consent History of bleeding disorder, arterial or venous thrombosis ii. Co-existing medical conditions e.g. renal, liver disease iii. Multiple gestation iv. Polyhydramnios v. Co-existing uterine fibroid vi. Abnormal placentation vii. History of allergy to tranexamic acid or ethamsylate viii. Use of low dose aspirin or any anticoagulant ix. Body mass index at booking < 18kg/m2 or >30kg/m2 Adult: 19 Year-44 Year 18 Year(s) 35 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 05/12/2023 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre Owo Ondo state Owo 341101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Intraoperative and postoperative blood loss using visual and gravimetric assessment. 2. Preoperative and postoperative haemoglobin level using Brecher et al method. 3. Proportion of postpartum haemorrhage 4. Need for blood transfusion During and within 24 hours after Caesarean section
Secondary Outcome 1. Patients with any untoward side effect especially unilateral leg swelling, difficulty in breathing. 2. Patient’s satisfaction with intervention using Likert’s scale Before discharge after Caesarean section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Adekunle Ajasin road Owo Ondo state 341101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adebayo Saheed Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo, Ondo state Owo 341101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adebayo Saheed Y. Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo Owo 341101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Okeyemi Ajibade Department of Anaesthesia, Federal Medical Centre, Owo Owo 341101 Nigeria
Adeshina Adedotun Department of Community Medicine, Federal Medical Centre, Yenagoa Yenagoa Nigeria
Aiyeyemi Joseph Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo Owo Nigeria
Paul Odo Department of Haematology, Federal Medical Centre, Owo Owo Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Saheed Adebayo sirhid1005@gmail.com +2347067959789 Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo
City Postal code Country Position/Affiliation
Owo 341101 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Saheed Adebayo sirhid1005@gmail.com +2347067959789 Department of Obstetrics and Gynaecology, Federal Medical Centre, Owo
City Postal code Country Position/Affiliation
Owo 341101 Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Okeyemi Ajibade talktorhymes@yahoo.com +2348060418129 Department of Anaesthesia, Federal Medical Centre, Owo
City Postal code Country Position/Affiliation
Owo 341101 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data (IPD) summary results. All of the individual participant data collected during the trial after deidentification. Informed Consent Form,Statistical Analysis Plan,Study Protocol October 2024 to April 2025 Open
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