E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036417 |
E.1.2 | Term | Post-partum haemorrhage |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The WOMAN Trial aims to determine the effect of the early administration of tranexamic acid (TXA) on death and hysterectomy in women with a clinical diagnosis of postpartum haemorrhage. |
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E.2.2 | Secondary objectives of the trial |
The secondary research objectives for the WOMAN Trial is to determine the effect of the early administration of tranexamic acid on:
(a) Surgical Interventions: including hysterectomy, brace suture -Lynch/Cho), selective arterial embolisation, laparotomy for other reasons, manual removal of placenta, intrauterine tamponade (packing or gauzing the uterine cavity, condom-catheter, any other method of intrauterine tamponade), to achieve haemostasis.
(b) Blood transfusion – blood or blood component units transfused.
(c) Health Status measured using the EQ-5D.
(d) Thromboembolic events (myocardial infarction, strokes, pulmonary embolism, DVT). (e) Other relevant medical events.
(f) Length of stay at hospital/time spent at an intensive care unit.
(g) Need for mechanical ventilation.
(h) Status of breastfed baby/ies.
(i) Cost effectiveness analysis: If the results of this trial show tranexamic acid to be effective in the trreatment of postpartum haemorrhage, |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All legally adult (16 years old and above in the UK) women with clinically diagnosed postpartum haemorrhage following vaginal delivery or caesarean section. Clinical diagnosis of postpartum haemorrhage may be based on an estimated blood loss of:
- greater than 500mls blood loss after vaginal delivery OR - greater than 1000mls blood loss after ceasarean section, OR - any amount of blood loss sufficient to compromise the haemodynamic status of the woman. |
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E.4 | Principal exclusion criteria |
The fundamental eligibility criterion is the responsible clinician’s ‘uncertainty’ as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage. Women for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Women for whom there is considered to be a clear contraindication for antifibrinolytic therapy (as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The composite primary outcome measure is death or hysterectomy in hospital within 42 days of delivery. Cause of death will be described. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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After 15,000 patients have been recruited (anticipated to be completed by 31st December, 2015), the trial will end when follow up (max 42 days) of the last patient recruited is completed. The trial may be terminated early by the Trial Steering Committee on the recommendation of the Independent Data Monitoring Committee on their interim reviews of the unblinded data. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 10 |