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.: PACTR202310814099421 Date of Approval: 10/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of two varying doses of intravenous tranexamic acid on blood loss after vaginal delivery at term in University of Benin Teaching Hospital
Official scientific title The effect of two varying doses of intravenous tranexamic acid on blood loss after vaginal delivery at term in University of Benin Teaching Hospital: a double-blinded randomized placebo controlled trial
Brief summary describing the background and objectives of the trial Primary postpartum haemorrhage is a common cause of maternal mortality especially in third world countries where there is relative lack of blood transfusion services, coupled with the high prevalence of anaemia in pregnancy which makes women in these settings more prone to adverse outcome from PPH. this underscores the need to explore other innovative strategies for the prevention of PPH in addition to the active management of third stage labour recommended by the World Health Organization. Tranexamic acid is currently recommended in the management of PPH. however, its role in the prevention of PPH is still being studied. this study seeks to explore the effect of tranexamic acid on reducing blood loss following vaginal delivery as a surrogate for the prevention of PPH.
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 primary postpartum haemorrhage
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2024
Actual trial start date
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 135
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
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
Control Group sterile water 10ml stat the patients in this group will receive 10ml of sterile water intravenously over 2minutes 45 Placebo
Experimental Group tranexamic acid 1g in 10ml stat patients in this group will receive 1g of tranexamic acid intravenously over 2minutes 45
Experimental Group tranexamic acid 500mg 500mg in 10ml patients in this group will receive 500mg of tranexamic acid intravenously over 2minutes 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women with gestation age between 37 completed weeks to 41weeks and 6days and Parity 0-4 admitted in labour (spontaneous labour or induction of labour) Gave consent for the study Had vaginal delivery Any woman with gestation age between 37 completed weeks to 41weeks and 6days admitted in labour (spontaneous labour or induction of labour) who did not give consent for the study Any woman who has history of thrombosis or epilepsy, history of medical/surgical conditions involving the heart, liver, kidney and brain, have known allergy to tranexamic acid, and bleeding disorders and abnormalities before pregnancy. Eventually delivered by Caesarean section after meeting inclusion criteria Adult: 19 Year-44 Year 15 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 04/10/2023 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
ugbowo-lagos road Benin City PMB1111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean blood loss 2 hours after vaginal delivery
Secondary Outcome change in haematocrit and haemoglobin concentration from before and after delivery on admission and 24hours after delivery
Secondary Outcome need for additional uterotonic 2hours after delivery
Secondary Outcome need for blood transfusion 24hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNIVERSITY OF BENIN TEACHING HOSPITAL Ugbowo-Lagos road Benin City PMB1111 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Michael Osahumen Orhue Ugbowo-Lagos road Benin City PMB1111 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Centre for excellence in reproductive health initiative Ugbowo-Lagos road Benin City Nigeria Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Orhue mykelorhue@gmail.com +2348039473079 Ugbowo-Lagos road
City Postal code Country Position/Affiliation
Benin City Nigeria Specialist Registrar
Role Name Email Phone Street address
Public Enquiries Michael Orhue mykelorhue@gmail.com +2348039473079 Ugbowo-Lagos Road
City Postal code Country Position/Affiliation
Benin City Nigeria Specialist Registrar
Role Name Email Phone Street address
Scientific Enquiries Michael Orhue mykelorhue@gmail.com +2348039473079 Ugbowo-Lagos Road
City Postal code Country Position/Affiliation
Benin City Nigeria Specialist Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in postpartum haemorrhage. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party Informed Consent Form,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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