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.: PACTR201706002304422 Date of Approval: 20/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tranexamic acid for prevention of bleeding at caesarean section
Official scientific title Efficacy of tranexamic acid at reducing blood loss during elective caesarean section in Abakaliki: a randomized double blind placebo controlled trial
Brief summary describing the background and objectives of the trial The rate of caesarean section is rapidly increasing globally. Its commonest and most dreaded complication is increased risk of bleeding which occasionally may be life threatening. Until recently, uterotonics especially oxytocin have been the only drug used to reduces blood loss. Tranexamic acid (TXA), an anti-fibrinolytic agent, has recently been investigated as a potentially useful drug for both prevention and treatment of excessive blood loss at caesarean section and merits evaluation in our environment. This study was designed to evaluate the efficacy of tranexamic acid at reducing the quantity of blood loss at elective caesarean section in Abakaliki south east Nigeria. Availability of such drug would lead to a reduction in the need for blood transfusion and its attendant consequences as well as reduction in maternal morbidity and mortality. This will a double blind randomized placebo controlled trial on the efficacy and safety of intravenous tranexamic acid at reducing blood loss in women undergoing elective caesarean section at the Federal Teaching Hospital Abakaliki (FETHA) and Mile 4 Hospital Abakaliki. The aim of the study would be to determine the effect of tranexamic acid on reducing the quantity of blood loss during and after elective caesarean section. The specific objectives would be 1. To determine the effects of tranexamic acid at reducing change in haematocrit after elective caesarean section. 2. To determine if addition of tranexamic acid reduces the need for additional uterotonics at elective caesarean section. 3. To determine if addition of tranexamic acid reduces the need for blood transfusing following elective caesarean section 4. To determine effects of tranexamic acid on maternal vital signs and neonatal outcome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied bleeding at caesarean section,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 01/12/2017
Actual Last follow-up date 31/12/2017
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 computer generated random numbers 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 group 1g intravenous tranexamic acid at 1mL per minute over 10minutes single dose give at preloading 1g (10mL) of intravenous tranexamic acid given over 10minutes starting about 20minutes before the surgery 60
Control Group Control group 10mL of water for injection Single dose given 20minutes before the surgery 20mL of sterile water would be given at preloadind starting about 20minutes before the surgery 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Parturients with singleton pregnancy at 37-42 weeks¿ gestational age 2. Patient on admission for elective caesarean section 3. patients without contraindication to tranexamic acid 4. patient who have signed the informed consent 1. Women who have known allergy to tranexamic acid 2. Women with prior history of thromboembolism 3. Women with bleeding disorders 4. Patients with renal disease 5. Patients with liver pathology 6. Patients with chronic hypertension 7. Patients with preeclampsia/eclampsia 8. Women with antepartum haemorrhage 9. Patients with varicose veins at increased risk of deep vein thrombosis 10. Patients who do not consent to the study. 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 02/11/2016 fedral teaching hospital human research and ethics committee
Ethics Committee Address
Street address City Postal code Country
PMB 102 abakaliki ebonyi state 84001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Estimated blood loss at elective Caesarean section each patient would have a preoperative packed cell volume done on admission and at day 2 following the surgery. their weight would also be ascertained the difference in the haematocrit would be used to determine the estimated blood loss.
Secondary Outcome Excessive blood at Caesarean section loss defined as blood loss > 1000ml estimated blood loss greater than or equal to 1000mL
Secondary Outcome Change in haematocrit after Caesarean section difference in the preoperative packed cell volume and the post operative packed cell volume done at day 2 post surgery
Secondary Outcome The need for additional uterotonics to control bleeding any additional uterotonics used during the surgery to control bleeding
Secondary Outcome The need for blood transfusion during or after the surgery at the surgery any other day before discharge from the hospital
Secondary Outcome any maternal side effects 1. during the surgery 2. any time from end of surgery to 6 weeks post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mile 4 hospital abakaliki abakaliki ebonyi state 84001 Nigeria
Federal teaching hospital abakaliki Abakaliki Ebonyi state 84001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
federal teaching hospital abakaliki abakaliki ebonyi state 84001 Nigeria
Dr obi vitus o 16 benigwenyi street abakaliki ebonyi state 84001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor federal teaching hospital abakaliki abakaliki ebonyi state 84001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
obi vitus o 16 benigwenyi street abakaliki ebonyi state 84001 Nigeria
prof Umeora OUJ federal teaching hospital abakaliki ebonyi state 84001 Nigeria
dr Dimejesi IBO federal teaching hospital abakaliki ebonyi state 84001 Nigeria
dr Asiegbu o federal teaching hospital abakaliki ebonyi state 84001 Nigeria
dr mgbafulu cc federal teaching hospital ebonyi state 84001 Nigeria
dr adebayo a federal teaching hospital abakaliki ebonyi state 84001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator vitus obi obivitus04@gmail.com +2348038884406 16 benigwenyi street abakaliki
City Postal code Country Position/Affiliation
ebonyi 84001 Nigeria none
Role Name Email Phone Street address
Public Enquiries christian mgbafulu khris201@yahoo.com +2348035394438 federal teaching hospital abakaliki
City Postal code Country Position/Affiliation
ebonyi 84001 Nigeria none
Role Name Email Phone Street address
Scientific Enquiries vitus obi obivitus04@gmail.com +2348038884406 16 benigwenyi street abakaliki
City Postal code Country Position/Affiliation
ebonyi 84001 Nigeria none
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information