Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Caesarean Delivery: a Multicenter Randomized Double Blind Placebo Controlled Therapeutic and Pharmaco-biological Dose Ranging Study (TRACES) for Its Optimal Benefit/Risk
Brief Summary: TRACES trial is a multicenter randomized double blind placebo control therapeutic and pharmaco-biological dose ranging study to measure the effect on blood loss reduction of a single intravenous infusion of two doses regimens (standard dose and low dose) of TA administered at the onset of an active PPH (\>800mL) during elective or non-emergent CS and to correlate this clinical effect with the biological effect of fibrinolysis inhibition and the pharmacodynamic measure of TA uterine bleeding and venous blood concentration.


Options:
A: Inclusion Criteria:

1. Intrauterine pregnancy
2. Age ≥ 18
3. Gestation age ≥ 37 weeks 0 days
4. Scheduled cesarean delivery
5. Second or third cesarean delivery
6. Singleton pregnancy

Exclusion Criteria:

1. First cesarean delivery
2. Four or more cesarean deliveries
3. Intrauterine fetal death
4. Fetal anomalies
5. Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
6. Thrombocytopenia (Platelet count \< 100k)
7. Internal bleeding, external bleeding, easy bruising
8. History of thrombotic event
9. Hypertension
10. Diagnosis of renal insufficiency (Creatinine\> 1 mg/dL)
11. Insulin-treated diabetes
12. Suspected morbidly adherent placenta
13. Placenta previa
14. Multiple Gestations
15. BMI ≥ 50
16. Hematocrit ≤ 25
17. Blood transfusion within 24 hours prior to cesarean delivery
18. History of abnormal bleeding or blood disorder
19. Planned general anesthesia
B: 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
C: 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.
D: Inclusion Criteria:

Experimental group: Each patient

* experiencing a bleeding volume of more than 800 mL
* due to surgery or to atony uterine
* during an elective or non-emergent caesarean section
* secondary post-partum haemorrhage after caesarean section, even if CS has been emergent
* after complete information and consent signature.
* covered by social security. Reference non-hemorrhagic group: Each patient
* experiencing a bleeding volume of strictly less than 800 mL
* during an elective or emergent caesarean section
* after complete information and consent signature.
* covered by social security.

Exclusion Criteria:

Patient unable to consent (\<18 years old or incapable people and specially protected mentioned in the article L1121-5 to L1121-8) RCP medical contraindication to tranexamic acid such as

* Hypersensibility to the product or excipient,
* Previous or ongoing arterial or venous thrombosis,
* Coagulopathy, except DIC associated with a predominant fibrinolytic profile,
* Renal failure,
* Previous seizures,
* intrathecal or intraventricular administration. Obstetrical contraindication to TA
* Severe HELLP syndrome (platelet count \<50 000/m3 or renal failure prior to the caesarean (RIFLE score\>2) Protocol related contraindication to inclusion
* Administration of TA before inclusion-Inherited haemorrhagic diseases and low molecular weight heparin within 24 hours before inclusion
* Patients who participated in a study on the efficacy of an experimental drug in the two month preceding the caesarean section
* Inherited haemorrhagic diseases or low molecular weight heparin within 24 hours before inclusion
* Previous inclusion in an interventional trial since the 2 months before CS

Answer: D