Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial
Brief Summary: The WOMAN trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 20,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Additionally, TWO nested studies will be conducted in a subset of women trial participants. The first nested study (ETAC) aims to evaluate the effect of tranexamic acid (TXA) on markers of coagulation in 400 women randomised to the WOMAN trial. The second nested study (ETAPLAT) aims to evaluate the haemostatic effect and antithrombotic effect of TXA in 128 women randomised to the WOMAN trial.


Options:
A: Inclusion Criteria:

* : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks,
* hemoglobin level at the last blood sample \>9g/dl,
* available blood test for Hb and Ht within one week before caesarean delivery,
* informed signed consent

Exclusion Criteria:

* previous thrombotic event or preexisting pro-thrombotic disease,
* epileptic state or history of seizures,
* presence of any chronic or active cardiovascular disease outside hypertension,
* any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease,
* sickle cell disease,
* placenta praevia,
* placenta accreta/increta/percreta,
* abruption placentae,
* eclampsia,
* HELLP syndrome,
* significant hemorrhage before cesarean section
* in utero fetal death,
* administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
* planned general anesthesia,
* hypersensitivity to tranexamic acid or concentrated hydrochloric acid,
* instrumental extraction failure,
* multiple pregnancy with vaginal delivery of the first child,
* poor understanding of the French language.
B: All legally adult women with postpartum haemorrhage following vaginal or caesarean section delivery who have a clinical diagnosis of postpartum haemorrhage. The clinical diagnosis of PPH may be based on any of the following:

* Blood loss after vaginal delivery \> 500 mL OR
* \> 1,000 mL after caesarean section OR blood loss sufficient to compromise the haemodynamic status of the woman 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 to antifibrinolytic therapy 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.
C: Inclusion criteria:

1. Undergoing noncardiac surgery;
2. ≥ 45 years of age;
3. Expected to require at least an overnight hospital admission after surgery;
4. Provide written informed consent to participate in the POISE-3 Trial, AND
5. Fulfill ≥1 of the following 6 criteria (A-F):

A. NT-proBNP ≥200 ng/L B. History of coronary artery disease C. History of peripheral arterial disease D. History of stroke E. Undergoing major vascular surgery; OR F. Any 3 of 9 risk criteria i. Undergoing major surgery; ii. History of congestive heart failure; iii. History of a transient ischemic attack; iv. Diabetes and currently taking an oral hypoglycemic agent or insulin; v. Age \>70 years; vi. History of hypertension; vii. Serum creatinine \> 175 µmol/L (\> 2.0 mg/dl); viii. History of smoking within 2 years of surgery; ix. Undergoing emergent/urgent surgery.

Exclusion criteria:

1. Patients undergoing cardiac surgery
2. Patients undergoing cranial neurosurgery
3. Planned use of systemic TXA during surgery
4. Low-risk surgical procedure (based on individual physician's judgment)
5. Hypersensitivity or known allergy to TXA
6. Creatinine clearance \<30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
7. History of seizure disorder
8. Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (\<3 month)
9. Patients with fibrinolytic conditions following consumption coagulopathy
10. Patients with subarachnoid hemorrhage within the past 30 days
11. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
12. Previously enrolled in POISE-3 Trial
D: Inclusion Criteria:

* Age≥ 18 years
* Planned vaginal delivery
* Term ≥ 35 weeks of gestation
* Singleton pregnancy
* Informed consent form signed

Exclusion Criteria:

* History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis.
* History of epilepsy or seizure
* Any known cardiovascular, renal, liver disorders
* Auto-immune disease
* Sickle cell disease
* Severe hemorrhagic disease
* Placenta previa
* Abnormally invasive placenta (placenta accreta/increta/percreta)
* Abruptio placentae
* Eclampsia; hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
* Multiple pregnancy
* In utero foetal death
* Administration of Low-Molecular-Weight Heparin or antiplatelet agents seven days before delivery
* Poor understanding of the French language

Answer: B