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.: PACTR202004798040817 Date of Approval: 24/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of the Effect of Prophylactic Intravenous Tranexamic Acid to Infusion Oxytocin as Adjuncts to Bolus Oxytocin on Blood Loss at Caesarean Section. A Randomised Study
Official scientific title Comparison of the Effect of Prophylactic Intravenous Tranexamic Acid to Infusion Oxytocin as Adjuncts to Bolus Oxytocin on Blood Loss at Caesarean Section. A Randomised Study
Brief summary describing the background and objectives of the trial Background: Postpartum haemorrhage and its attendant morbidity and mortality remains a challenge in our settings in Nigeria and it is a major complication during caesarean section. Tranexamic acid is an anti-fibrinolytic agent whose role in the prevention of excessive blood loss at caesarean section is of interest. Current international guidelines recommend the use of oxytocin for PPH prevention during caesarean section, however there is insufficient evidence regarding the effectiveness of continuous infusion in addition to bolus injection. The study aimed to compare the effectiveness of prophylactic intravenous tranexamic acid given before caesarean section versus oxytocin infusion commenced after neonatal delivery, both as adjunct to bolus oxytocin.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TROXY STUDY
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Prevention
Anticipated trial start date 01/01/2019
Actual trial start date 31/01/2019
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date 31/07/2019
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants) 144
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous Tranexamic Acid 1g before skin incision 5-20mls 1g tranexamic acid diluted up to 50ml with sterile water was administered atleast 30 minutes before surgery 72
Control Group Oxytoxin infusion 20IU in 500ml of normal saline 4 hours 50ml sterile water as placebo before skin incision + 500ml of Normal saline containing 20IU of oxytocin after delivery of neonate 72 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with singleton pregnancy at gestational age >37 weeks Non consenting women Multiple gestation Pregnancy with co-existing uterine fibroid Hypertensive disorders Anaemia (Hb<10g/dl) Heart disease Renal disease Liver disease Placenta praevia Abruption placenta Previous history of thromboembolism. Allergy to oxytocin or tranexamic acid. Adult: 19 Year-44 Year 19 Year(s) 44 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 27/07/2018 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 Difference in mean blood loss between both arms of the study Blood Lost up to 24 hours
Secondary Outcome - Incidence of postpartum haemorrhage in both arms of the study. - Incidences of greater than 10% fall in haemoglobin concentration in both arms of the study. - Proportion of women in both arms who require medical and surgical interventions. - Proportion of women who need blood transfusion in both arms of the study. - The proportion of women with haemodynamic instability and adverse drug effects. up to 48 hours
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 810211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Dogbanya Gabriel Sharia Court Street Palladan Zaria 810211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof MS Zayyan Department of Obgyn ABUTH Shika Zaria 810211 Nigeria
Prof Oguntayo AO Department of Obgyn Zaria 810211 Nigeria
Prof Kolawole AOD Department of Obgyn ABUTH Shika Zaria 810211 Nigeria
Dr Yakubu S.Y Department of Obgyn ABUTH Shika Zaria 810211 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dogbanya Gabriel angelgabosti@yahoo.com +2348030790966 Sharia Court Street Palladan
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Primary Researcher
Role Name Email Phone Street address
Public Enquiries Oguntayo AO fayokunmi@yahoo.co.uk +2348033109752 Department of Obsgyn ABUTH Shika
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Secondary Researcher
Role Name Email Phone Street address
Scientific Enquiries Zayyan MS marzayyan@gmail.com +2347039758776 Department of Obsgyn ABUTH Shika
City Postal code Country Position/Affiliation
Zaria 810211 Nigeria Secondary Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All colleceted IPD the underlie result in publication Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of sharing Result will be available are the PAN Clinical Registry and any other related publication site
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