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.: PACTR201804002955302 Date of Approval: 09/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title USEFULNESS OF TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING CAESAREAN DELIVERY IN IBADAN
Official scientific title EFFECT OF INTRAVENOUS TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING CAESAREAN DELIVERY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Background: The rate of caesarean delivery has increase to about 25-30% in many areas of the world and one of its major complications is haemorrhage which remains the leading cause of admission in intensive care unit and the most preventable cause of maternal mortality. American College of Obstetricians and Gynaecologists (ACOG) evaluation of caesarean deliveries found that overall mortality rate from caesarean delivery is 6/100,000 which is 3-7 times greater than that of vaginal delivery. Recent studies have also shown that primary caesarean delivery increases the risk of blood transfusion to about 4.2 times higher than vaginal delivery. Objective: To evaluate the efficacy of tranexamic acid in reducing blood loss in patients undergoing caesarean delivery.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,HAEMORRHAGE,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 11/11/2015
Actual trial start date 28/01/2016
Anticipated date of last follow up 10/11/2016
Actual Last follow-up date 20/05/2016
Anticipated target sample size (number of participants) 71
Actual target sample size (number of participants) 154
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 The study employed block randomization in groups of 4. The sequence of randomization was generated by a statistician using a computer programme. sequentially numbered envelopes in groups of 4 at a time Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal Saline 10mls statum dose intravenous administration of 10mls of normal saline 77 Placebo
Experimental Group Traxenamic acid 1g (10 mls) statum dose intravenous administration of 10mls of tranexamic acid just before skin incision 77
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women scheduled for primary elective or emergency caesarean delivery 1. Severe medical and surgical complications involving the heart, liver or kidney, and blood disorder. 2. Allergy to tranexamic acid. 3. Known risk factors for postpartum haemorrhage such as previous caesarean delivery, multiple pregnancy, placenta praevia, morbidly adherent placenta, previous myomectomy, co-existing uterine fibroid in pregnancy. 4. History of thrombo-embolic disorder or risk factors for thromboembolic disorder such as Sickle Cell disease. 5. Refusal to consent. 18 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 11/11/2015 UI/UCH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
IAMRAT, College of Medicine Ibadan Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Amount of blood loss during caesarean delivery Total blood loss immediately after surgery was determined. Blood loss 2 hours after surgery was determined Maternal packed cell volume was determined on admission to labour ward and repeated 48 hours after delivery and the difference calculated
Secondary Outcome Need for additional uterotonics Intraoperative Up to 2 hours after surgery
Secondary Outcome Need for other surgical measures to stop bleeding Intra-operative Up to 2 hours post operative
Secondary Outcome Maternal and neonatal side effects of medications given Intraoperative Up to 2 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital, Ibadan Queen Elizabeth road, Mokola, Ibadan Ibadan PMB 5116 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim S. Halifa University College Hospital Ibadan PMB 5116 Nigeria
Timothy A. O. Oluwasola University College Hospital Ibadan PMB 5116 Nigeria
Adeniran O FAwole University College Hospital Ibadan PMB 5116 Nigeria
Adesina Oladokun University College Hospital Ibadan PMB 5116 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University College Hospital Queen Elizabeth road, Mokola, Ibadan Ibadan PMB 5116 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Pharmacy department University College Hospital Ibadan PMB 5116 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Salihu Halifa halifa.is@gmail.com +2348035973159 Queen Elizabeth Street, Mokola
City Postal code Country Position/Affiliation
Ibadan PMB 5116 Nigeria Resident Doctor
Role Name Email Phone Street address
Public Enquiries Timothy Abiola O. Oluwasola sesanoluwasola@yahoo.com +2348033384064 Queen Elizabeth Street, Mokola
City Postal code Country Position/Affiliation
Ibadan PMB 5116 Nigeria Consultant Obstetrician/Univerrsity College Hospital, Ibadan
Role Name Email Phone Street address
Scientific Enquiries Adeniran Olubukola Fawole fawoleo@yahoo.co.uk +2348033182802 Queen Elizabeth Street, Mokola
City Postal code Country Position/Affiliation
Ibadan PMB 5116 Nigeria Professor/University of Ibadan
Role Name Email Phone Street address
Scientific Enquiries Adesina Oladokun sinaoladokun@yahoo.com +2348033285279 Queen Elizabeth Street, Mokola
City Postal code Country Position/Affiliation
Ibadan PMB 5116 Nigeria Professor/University of Ibadan
REPORTING
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