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.: PACTR201007000192283 Date of Approval: 09/02/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title WORLD MATERNAL ANTIFIBRINOLYTIC TRIAL
Official scientific title Tranexamic acid for the treatment of postpartum haemorrhage: An international, randomised, double blind, placebo controlled trial
Brief summary describing the background and objectives of the trial Each year, about 14 million mothers develop postpartum haemorrhage (PPH) and around 2 percent of them will die. The WOMAN trial is a large pragmatic randomised placebo controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid (TXA) on death, hysterectomy and other clinical outcomes in women with PPH. Thromboembolic effects on breastfed babies will also be assessed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) THE WOMAN TRIAL
Disease(s) or condition(s) being studied Circulatory System,Postpartum haemorrhage,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2009
Actual trial start date 22/03/2010
Anticipated date of last follow up 12/05/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 20060
Recruitment status Completed
Publication URL http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30638-4/fulltext
Secondary Ids Issuing authority/Trial register
2008-008441-38 EUDRACT NUMBER
NCT00872469 ClinicalTrials.gov
ISRCTN76912190 PROTOCOL NUMBER
ISRCTN76912190 PROTOCOL NUMBER
2008-008441-38 EUDRACT NUMBER
NCT00872469 ClinicalTrials.gov
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 Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK). Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK). Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK). Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK). Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK). Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation. Treatment packs containing TXA and placebo will be packed in balanced blocks of 8 (4 TXA: 4 Placebo) into a box in random order Randomisation codes will be generated and secured by an independent statistical consultant from Sealed Envelope Ltd (UK). Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Sodium chloride 0.9% fixed dose of 10 mL initially, followed by 10 mL if after 30 minutes bleeding continues, or if it stops and restarts within 24 hours after the first dose To be administered by intravenous injection at an approximate rate of 1 mL/minute 10 mL sodium chloride 0.9% given as a slow intravenous injection 7500 Placebo
Experimental Group Tranexamic acid fixed dose of 1 gram initially, followed by 1 gram if after 30 minutes bleeding continues, or if it stops and restarts within 24 hours after the first dose To be administered by intravenous injection at an approximate rate of 1 mL/minute 1 gram tranexamic acid given as a slow intravenous injection 7500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Immediately after delivery, all usual care should be given for the prevention of PPH. If bleeding continues and a clinician diagnosis of PPH is made, all usual treatments should be given and at the same time assessment for inclusion in the WOMAN Trial should be done. As most women die within 2 - 4 hours of delivery, it is important to consider inclusion as early as possible. Clinician diagnosis of PPH may be based on any of the following: 1. Blood loss after vaginal delivery greater than 500 ml, or 2. Greater than 1000 ml after caesarian section, or 3. Blood loss enough to compromise the haemodynamic status of the woman Other inclusion criteria: 4. All women who are clinician-diagnosed with postpartum haemorrhage following vaginal delivery or caesarean section 5. Consent has been obtained in line with local procedures 1. Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomised. 2. Women for whom the responsible clinician considers there is a clear contraindication for TXA should not be randomised. There are no other pre-specified exclusion criteria. Where the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage, the woman should be randomised. 16 Year(s) 150 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 28/07/2009 London School of Hygiene and Tropical Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Composite of Death, and Peripartum hysterectomy The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 1. Surgical interventions used to treat obstetric haemorrhage: 1.1. Hysterectomy 1.2. Any brace suture 1.3. Arterial ligation 1.4. Artery selective embolisation The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 2. Transfusion requirements (blood/components) The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 3. Thromboembolic events: 3.1. Deep venous thrombosis 3.2. Pulmonary thromboembolism 3.3. Stroke 3.4. Myocardial infarction The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 4. Length of stay in hospital The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 5. If an Intensive Care Unit is available, time spent in the ICU The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 6. Suspected Unexpected Serious Adverse Reactions (SUSAR) The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 7. Death The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 8. Health Related Quality of life (HRQoL) At discharge from the randomising hospital or in hospital at 42 days after randomisation
Secondary Outcome 9. Receipt of mechanical ventilation The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 10. Status of baby/ies up to 6 weeks of delivery The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first.
Secondary Outcome 11. Cost-effectiveness analysis An economic analysis will be relevant if TXA clearly demonstrates efficacy in achieving its clinical aims.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Coordinator: Kenyatta National Hospital Nairobi Kenya
Worldwide please see: http://www.womantrial.lshtm.ac.uk/
National Coordinator: Regional Hospital Limbe Cameroon
National Coordinator: University College Hospital Ibadan Ibadan Nigeria
National Co-ordinator: Soba University Hospital Khartoum Sudan
National Co-ordinator: University Teaching Hospital Lusaka Zambia
National Co-ordinator: Ashanti Mampong Municipal Hospital Mampong Municipality, Ghana Ghana
National Coordinator: Hope Hospital, Goma Goma Democratic Republic of the Congo
National Coordinator: Centre MURAZ Burkina Faso
National Coordinator: St Paul's Millenium Hospital Addis Ababa Ethiopia
National Coordinator: Mulago Hospital Mulago Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
Department of Health and Wellcome Trust (UK) Ukraine
Bill and Melinda Gates Foundation United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
Primary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Worldwide See website: http://www.womantrial.lshtm.ac.uk
Dr Zahida Qureshi Kenyatta National Hospital, University of Nairobi Kenya
Dr Robert Tchounzou Regional Hospital, Limbe Cameroon
Dr Anthony Kwame Da Ashanti Mampong Municipal Hospital Ghana
Dr Bellington Vwalika University Teaching Hospital Lusaka Zambia
Worldwide See website: http://www.womantrial.lshtm.ac.uk
Dr Zahida Qureshi Kenyatta National Hospital, University of Nairobi Kenya
Dr Robert Tchounzou Regional Hospital, Limbe Cameroon
Dr Anthony Kwame Da Ashanti Mampong Municipal Hospital Ghana
Dr Bellington Vwalika University Teaching Hospital Lusaka Zambia
Dr Mohamed Awad Ahme Soba University Hospital Sudan
Dr Mohamed Awad Ahmed Soba University Hospital Sudan
Dr Mateus Sahani Hope Hospital Goma Democratic Republic of the Congo
Dr Abdulkadir Abdulfetah St Paul's Millenium Hospital Addis Ababa Ethiopia
Dr Christine Biryabarema Mulago Hospital Mulago Uganda
Prof Nicola Meda Centre MURAZ Burkina Faso
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ian Roberts thewomantrial@lshtm.ac.uk +44 (0)20 7299 4684 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor of Epidemiology
Role Name Email Phone Street address
Public Enquiries Haleema Shakur thewomantrial@lshtm.ac.uk +44 (0)20 7299 4684 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Haleema Shakur thewomantrial@lshtm.ac.uk +44 (0)20 7299 4684 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Trial Manager
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