Postpartum haemorrhage Pregnancy and Childbirth Postpartum haemorrhage
Conditions
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
Sponsors
London School of Hygiene and Tropical Medicine (LSHTM) (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Death (cause of death will be described) 2. Peripartum hysterectomy The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first. Added 08/01/2015: WOMAN-ETAC (sub-study) primary outcome: The primary outcome is to evaluate the effect of tranexamic acid on fibrinolysis 30 minutes after the first dose is given. Fibrinolysis will be measured with D-dimer, fibrinogen level and using ROTEM parameters previously reported to be associated with fibrinolysis (i.e., MCF, CA10, CA15, CLI30, and CLI60). Levels of all parameters will be assessed on venous blood samples. WOMAN-ETAPlaT (sub-study) primary outcome: The primary outcome is the effect of tranexamic acid on thrombin generation at 30-60 minutes after the first dose is given. Thrombin Generation Assay [Lag Time (LT, min), peak height or time to peak (nMol) and area under the curve or endogenous thrombin potential (ETP, measured in nmol/L per min)] Levels of all parameters will be assessed on venous blood samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Mortality (outcome added 08/01/2015) 3. Transfusion requirements (blood/components) 4. Thromboembolic events: 4.1. Deep venous thrombosis 4.2. Pulmonary thromboembolism 4.3. Stroke 4.4. Myocardial infarction 5. Length of stay in hospital 6. If an Intensive Care Unit is available, time spent in the ICU 7. Suspected Unexpected Serious Adverse Reactions (SUSAR) 8. Status of baby up to 6 weeks of delivery The outcome is collected at death, discharge or 6 weeks after randomisation, whichever occurs first. Added 08/01/2015: WOMAN-ETAC (sub-study) secondary outcome: As a secondary outcome we will evaluate the relationship between coagulation parameters and mortality. WOMAN-ETAPlaT (sub-study) secondary outcome: Secondary outcomes will include effect of tranexamic acid on platelet function, fibrinogen, D-Dimer and coagulation factor V, VIII and vWF levels. | — |
Countries
Albania, Bangladesh, Burkina Faso, Cameroon, Colombia, Egypt, Ethiopia, Ghana, Jamaica, Kenya, Nepal, Nigeria, Pakistan, Sudan, Tanzania, Uganda, United Kingdom, Zambia
Outcome results
None listed