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.: PACTR202004568331645 Date of Approval: 19/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF TRANEXAMIC ACID ON PRIMARY POSTPARTUM HAEMORRHAGE IN AT – RISK WOMEN AT ABUTH, ZARIA: A RANDOMIZED CONTROLLED STUDY
Official scientific title EFFECT OF TRANEXAMIC ACID ON PRIMARY POSTPARTUM HAEMORRHAGE IN AT – RISK WOMEN AT ABUTH, ZARIA: A RANDOMIZED CONTROLLED STUDY
Brief summary describing the background and objectives of the trial Background: Postpartum haemorrhage is an obstetric nightmare. Although it may occur in women with no risk, certain factors increase its likelihood. Tranexamic acid is a potent anti-fibrinolytic agent, whose role in PPH prevention is of interest. Aim: To compare the effectiveness of intravenous Tranexamic acid to placebo, both as adjuncts to intramuscular oxytocin, to prevent PPH in at-risk women following vaginal delivery. Research Methods: A randomized double blind controlled trial, in which 334 women identified as being at risk for PPH, will be divided into two groups. The Tranexamic acid group will receive intravenous 1g Tranexamic acid diluted in 20ml 0.9% Normal saline at delivery, while the placebo group will receive 20ml 0.9% Normal saline. Both groups will receive 10IU intramuscular oxytocin as part of active management of third stage of labour protocol. Blood loss will be collected objectively in a blood collection drape at delivery. The primary outcome is the proportion of women with blood loss greater than 500ml in both arms, while the secondary outcomes include percentage fall in haemoglobin concentration 24 hours after delivery and proportion of women in both arms that require additional oxytocic or blood transfusion. Planned handling of results: Results would be analysed using SPSS version 21 and presented as frequencies and percentages. Means and standard deviations will be calculated for maternal age, gestational age and amount of blood loss. Unpaired t-test will be used to find significance between the two groups with regards to continuous variables, while chi squared test will be used to find significance in the incidence of PPH and fall in haemoglobin concentration greater than 10% at p-value of < 0.05. Strengths and Limitations: The study offers prevention and prompt diagnosis of PPH. However, liquor may add to blood loss collected by the collection drape and affect the estimated blood loss.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TROPPHAR
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Postpartum Haemorrhage
Purpose of the trial Early detection /Screening
Anticipated trial start date 30/07/2019
Actual trial start date 30/08/2019
Anticipated date of last follow up 30/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 334
Actual target sample size (number of participants)
Recruitment status 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 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 Group A tranexamic acid group 1g tranexamic acid (10ml) is made up to 20ml start 5 minutes Group A will receive 1g TXA diluted up to 20ml (with 0.9% Normal saline), as an intravenous solution slowly over 5 minutes after delivery of neonate 167
Control Group Placebo Group 20ml of saline 5 minutes 20ml of saline administered after delivery of neonate as part of third stage management 167 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with singleton pregnancy at gestational age: 37weeks 1day to 41weeks 6 days with any of the following risk factors: Previous history of PPH Nullipara Grand multipara Induced, augmented or prolonged labour Hypertensive disorders Obesity Anaemia (Hb<10g/dl) Bleeding disorders. Non consenting women Diabetes mellitus in pregnancy Heart disease Renal disease Liver disease Past history of deep venous thrombosis Placenta praevia Severe abruption placentae Allergy to tranexamic acid Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 04/10/2018 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Shika Zaria Zaria 810211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women with blood loss > 500ml in both arms of the study At Delivery
Secondary Outcome 1. Percentage fall in haemoglobin 24 hours after delivery in both arms of the study. 2. Proportion of women in both arms who require additional uterotonics or manouvres. 3. Proportion of women in both arms who need blood transfusion 4. Any adverse effect of drug in the study group. Up to 24 hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Shika Zaria Zaria 810211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Dogbanya Gabriel Sharia Court Street Palladan Zaria Zaria 810211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Dogbanya Gabriel No 11 Sharia Court Street Palladan Zaria Zaria 810211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof M.S Zayyan Ahmadu Bello University Teaching Hospital Zaria 810211 Nigeria
Dr N.H Madugu Ahmadu Bello University Teaching Hospital Zaria 810211 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gabriel Dogbanya angelgabosti@yahoo.com +2348030790966 No 11 Sharia Court Street Palladan
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Marliyya Zayyan marzayyan@gmail.com +2347039758776 Obstetrics and Gynaecology Department ABUTH
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Nana Hauwa Madugu madugu20007@yahoo.com +2348035896570 Obstetrics and Gynaecology Department ABUTH
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlie result in a publication Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within a year of conclusion of study All those registered researchers interested in the study area
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