Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial
Brief Summary: A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.


Options:
A: Inclusion Criteria:

* 18 years of age or older
* Singleton pregnancy
* Confirmed pregnancy
* Gestational age \>32\^0/7 weeks

Exclusion Criteria:

* Lack of patient consent
* Multiple pregnancy
* History of eclampsia or preeclampsia in current pregnancy
* Imminent Delivery as suspected by any RN or MD involved in delivery care
* History of cardiovascular complications:

  * Coronary artery disease or myocardial infarction
  * Repaired or unrepaired congenital heart disease
  * Vascular disease(s)
  * Severe unstable arrhythmia (e.g. Rapid atrial fibrillation, paroxysmal fibrillation, atrial flutter, etc.)
  * Congestive heart failure
* Contraindication to TXA:

  * History of venous thromboembolism
  * Active thromboembolic disease
  * High risk of thrombosis (e.g. Factor V Leiden or Protein C deficiency)
  * Acquired disturbances of colour vision
  * Allergy to TXA
  * History of seizure disorder
  * Pre-existing hematuria
  * History of renal insufficiency
* Unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town)
* Prisoner status
B: Inclusion Criteria:

* gestational age between 37 and 42 weeks,
* live fetus,
* cephalic presentation,
* vaginal birth.
* Patients who had a risk factors for PPH, such as multiple gestation, polyhydramnios, fetal macrosomia, antepartum hemorrhage, anemia (haemoglobin concentration \< 8 g/dL), severe pre-eclampsia, or coagulopathy

Exclusion Criteria:

* placenta previa,
* placental abruption,
* cesarean section or any uterine scar, abnormal placentation (accreta, increta, or percreta),
* a current or previous history of significant disease, including heart disease, liver, renal disorders.
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:

1. Scheduled or unscheduled cesarean delivery
2. Singleton or twin gestation

Exclusion Criteria:

1. Age less than 18 years
2. Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative hemorrhage
3. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated
4. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis
5. Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and its use has been associated with postoperative seizures
6. Serum creatinine 1.2 or higher or on dialysis, with renal disease, or a history of renal insufficiency, because TXA is substantially excreted by the kidney, and impaired renal function may increase the risk of toxic reactions.
7. Sickle cell disease, because of substantial use of perioperative transfusion unrelated to hemorrhage. Sickle cell trait is not an exclusion per se.
8. Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism
9. Need for therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA
10. Treatment with clotting factor concentrates, because the risk of thrombosis may be increased with TXA
11. Presence of frank hematuria, because the risk of ureteral obstruction in those with upper urinary tract bleeding may be increased with TXA
12. Patient refusal of blood products because the primary outcome is then pre-determined
13. Receipt of TXA; or planned or expected use of TXA prophylaxis
14. Active cancer, because of risk of thromboembolism
15. Congestive heart failure requiring treatment, because of risk of thrombosis
16. History of retinal disease, because the risk of central retinal artery or vein obstruction may be increased with TXA
17. Acquired defective color vision or subarachnoid hemorrhage, since TXA is contraindicated
18. Hypersensitivity to TXA or any of the ingredients
19. No hemoglobin result available from the last 4 weeks, since it is necessary to measure the post-operative change in hemoglobin
20. Scheduled cesarean delivery and quota for scheduled deliveries already met. Quotas on the number of scheduled and unscheduled deliveries will be placed to ensure approximately equal distribution of scheduled and unscheduled cesarean deliveries.
21. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
22. Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
23. Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
24. Symptomatic for COVID-19 infection within 14 days prior to delivery

Answer: D