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.: PACTR202010828881019 Date of Approval: 12/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tranexamic acid for reducing blood loss following vaginal delivery
Official scientific title Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized placebo controlled trial.
Brief summary describing the background and objectives of the trial Background: Post partum haemorrhage (PPH) is a major cause of maternal morbidity and mortality worldwide with the highest incidence in the developing countries.1 Risk factors for PPH abound, however most women who experience PPH have low risk pregnancies or no risk at all. It therefore becomes imperative to prevent PPH in all pregnant women.13 The administration of uterotonics and in particular oxytocin, after birth is an effective component of active management of third stage of labour used in preventing PPH.19,20,21 Tranexamic acid (TXA), an anti-fibrinolytic agent, has recently been investigated as a potentially useful drug for prevention of PPH following vaginal delivery and merits evaluation in our environment. Objective: This study is designed to evaluate the efficacy of tranexamic acid at reducing blood loss following vaginal delivery. Methodology: This will be a double blind randomized placebo controlled study on the efficacy and safety of intravenous tranexamic acid at reducing blood loss in women undergoing vaginal delivery at the Federal Teaching Hospital Abakaliki (FETHA). Data (from the outcome measures) would be analyzed using Statistical Package for Social Sciences (IBM SPSS) software (version 20, Chicago II, USA). Continuous variables would be presented as means and standard deviations (Mean ± 2SD), while categorical variables would be presented as numbers and percentages. A difference with a p-value <0.05 would be considered statistically significant. The primary outcome would be the mean blood loss following vaginal delivery of the drug group versus that of patients treated with placebo. Other outcome measures like additional uterotonics used, blood transfusion and maternal side effects would be compared between both groups. The efficacy and safety of intravenous tranexamic acid at reducing the quantity of blood loss would be determined from the above comparison. Key words: Tranexamic acid, blood loss, vaginal delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TXA
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 Prevention
Anticipated trial start date 01/06/2017
Actual trial start date 03/06/2017
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 31/12/2017
Anticipated target sample size (number of participants) 176
Actual target sample size (number of participants) 162
Recruitment status Completed
Publication URL Not yet published
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tranexamic acid administered to the consenting patients who meet the inclusion criteria 1g (10ml) Within 30 to 60 seconds of delivery of the baby and after oxytocin administration Group A received 1g tranexamic acid (Exacyl®; Sanofi Aventis Paris France) slowly (over 30-60 seconds) intravenously, within 2 minutes after birth and prophylactic oxytocin administration once the cord had been clamped. 88
Control Group Sterile water 10ml 30-60 seconds within 2 minutes of delivery of the baby Control 88 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Spontaneous labour in booked patients 2. Planned vaginal delivery 3. Term pregnancy 4. Singleton pregnancy and cephalic presentation 5. Parturient who has no contraindication to the use of tranexamic acid 6. Informed consent form signed 1. Women with prior history of thromboembolism/autoimmune/ sickle cell disease 2. Women with bleeding disorders 3. Patients with renal disease, liver pathology, known cardiovascular disease 4. Multiple pregnancy/intra-utero fetal death/previous uterine surgeries 5. Patients with chronic hypertension 6. Patients with preeclampsia/eclampsia/HELLP syndrome 7. Women with antepartum haemorrhage/ruptured uterus 8. Patients with varicose veins at increased risk of deep vein thrombosis 9. History of epilepsy/seizure 10. Episiotomy Adult: 19 Year-44 Year 19 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 09/06/2017 Research and Ethics Committee Federal Teaching Hospital Abakaliki
Ethics Committee Address
Street address City Postal code Country
No. 1, Chidume Street, Behind State Prison Headquarters, Abakaliki, Ebonyi State, Nigeria Abakaliki 480221 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Estimated blood loss following vaginal delivery (total blood loss following vaginal delivery= estimated blood from cylinder+ difference in the weight of pad) Following delivery of the placenta
Secondary Outcome 1. Primary PPH following vaginal delivery defined as blood loss > 500ml 2. The need for additional uterotonics to control bleeding 3. The need for blood transfusion (volume and amount) after vaginal delivery 4. Mild maternal side effects (nausea, vomiting, headache, skin rash) 5. Major maternal side effects (thromboembolism, maternal death) 2hours after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alex Ekwueme Federal University Teaching Hospital Abakaliki No. 1, Chidume Street, Behind State Prison Headquarters, Abakaliki, Ebonyi State, Nigeria. Abakaliki 480221 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Igboke Francis N Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki Abakaliki 480221 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francis Igboke igbokefrancisn@gmail.com +2348037811200 Department of Obstetrics and Gynaecology, Alex-Ekwueme Federal University Teaching Hospital
City Postal code Country Position/Affiliation
Abakaliki 480211 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Osaheni Lucky Lawani lawkins2020@gmail.com +2348036691209 Department of Obstetrics and Gynaecology, Alex-Ekwueme Federal Teaching Hospital, Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480221 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Francis Igboke igbokefrancisn@gmail.com +2348037811200 Department of Obstetrics and Gynaecology, Alex-Ekwueme Federal Teaching Hospital Abakaliki
City Postal code Country Position/Affiliation
Abakaliki 480221 Nigeria Senior Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The results from this proposed study will be submitted to the Human Research and Ethics Committee (HREC) - FETHA. A dissertation would be made out from the findings of this study and submitted to the National Postgraduate Medical College of Nigeria, Faculty of Obstetrics & Gynaecology. It will also be presented at the departmental clinical conference as well as at the Society of Obstetricians and Gynaecologists of Nigeria (SOGON) conference. Finally it will be published in a reputable journal such as the Tropical Journal of Obstetrics and Gynaecology. Informed Consent Form,Statistical Analysis Plan,Study Protocol Following defense in the National Postgraduate Medical College of Nigeria in November 2020 Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized controlled trial.
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