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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| WOrld Maternal ANtifibrinolytic Trial |
| ISRCTN | ISRCTN76912190 |
| ClinicalTrials.gov identifier | NCT00872469 |
| Public title | WOrld Maternal ANtifibrinolytic Trial |
| Scientific title | Tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind, placebo controlled trial |
| Acronym | The WOMAN Trial |
| Serial number at source | N/A |
| Study hypothesis |
The WOMAN trial will provide reliable evidence as to whether the antifibrinolytic agent tranexamic acid can reduce mortality, hysterectomy and other morbidities in women with clinician-diagnosed postpartum haemorrhage (PPH).
As of 08/07/2010, the following countries of recruitment were added to this record: Albania, Cameroon. |
| Lay summary | |
| Ethics approval | LSHTM Ethics Committee (ref: 5536). All other centres will seek ethics approval before recruiting participants. |
| Study design | Large pragmatic randomised double blind placebo-controlled trial |
| Countries of recruitment | Albania, Cameroon, Nigeria |
| Disease/condition/study domain | Postpartum haemorrhage |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
1. The responsible clinician is uncertain as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage
2. The responsible doctor considers there to be a clear indication for antifibrinolytic therapy 3. Women for whom there is considered to be a clear contraindication to antifibrinolytic therapy When the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic, all these women are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria. |
| Anticipated start date | 01/03/2009 |
| Anticipated end date | 12/12/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 15,000 |
| Interventions | Women eligible for inclusion should be randomised, and the trial treatment started, as soon as possible. Randomisation to either active or placebo is done by telephoning a 24-hour freecall service. If telephone randomisation is not feasible a local pack system will be used where the next consecutively numbered treatment pack is taken from a box of eight packs. A loading dose of the trial treatment of tranexamic acid 1 g or placebo will be administered as soon possible, followed by a maintenance dose of tranexamic acid 1 g or placebo over eight hours. Outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first. |
| Primary outcome measure(s) |
1. Death
2. Peripartum hysterectomy The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first. |
| Secondary outcome measure(s) |
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 2. Transfusion requirements (blood/components) 3. Thromboembolic events: 3.1. Deep venous thrombosis 3.2. Pulmonary thromboembolism 3.3. Stroke 3.4. Myocardial infarction 4. Length of stay in hospital 5. If an Intensive Care Unit is available, time spent in the ICU 6. Suspected Unexpected Serious Adverse Reactions (SUSAR) 7. Status of baby up to 6 weeks of delivery The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first. |
| Sources of funding | London School of Hygiene and Tropical Medicine (LSHTM) (UK) |
| Trial website | http://www.womantrial.lshtm.ac.uk/ |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20398351 |
| Contact name | Ms Haleema Shakur |
| Address |
Department of Epidemiology and Population Health
London School of Hygiene and Tropical Medicine Keppel Street |
| City/town | London |
| Zip/Postcode | WC1E 7HT |
| Country | United Kingdom |
| Tel | +44 (0)20 7299 4684 |
| Fax | +44 (0)20 7299 4663 |
| thewomantrial@lshtm.ac.uk | |
| Sponsor | London School of Hygiene and Tropical Medicine (LSHTM) (UK) |
| Address | Keppel Street |
| City/town | London |
| Zip/Postcode | WC1E 7HT |
| Country | United Kingdom |
| Tel | +44 (0)20 7299 4684 |
| Fax | +44 (0)20 7299 4663 |
| thewomantrial@lshtm.ac.uk | |
| Sponsor website: | http://www.lshtm.ac.uk/ |
| Date applied | 08/12/2008 |
| Last edited | 08/07/2010 |
| Date ISRCTN assigned | 10/12/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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