Tranexamic Acid for the Prevention of Postpartum Haemorrhage

• Status: Recruiting
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: Female

Summary

Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Benha University
• Treatments: Oxytocin; Tranexamic Acid

Criteria

Inclusion Criteria:

Scheduled or unscheduled cesarean delivery. Singleton or twin gestation.

Women at high risk for PPH after cesarean section:

Placenta previa, accreta, increta or percreta. haematocrit (HCT) < 30%. Bleeding at admission. History of Postpartum haemorrhage. Abnormal vital signs (hypotension or tachycardia). Previous Cesarean or uterine surgery. More than four previous deliveries. Multiple Gestation. Large Uterine fibroids. Chorioamnionitis. Magnesium sulphate use. Prolonged use of oxytocin.

Exclusion Criteria:

1. Age less than 18 years.

2. Women who are not at high risk for PPH.

3. Women attending for normal vaginal delivery.

4. Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease.

5. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated.

6. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis.

7. 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

8. Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA.

9. Hypersensitivity to TXA or any of its ingredients.

10. 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 haemorrhage

11. Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures..

12. Active cancer, because of the risk of thromboembolism.

13. Congestive heart failure requiring treatment, because of the risk of thrombosis.

14. If there is no haemoglobin and hematocrit result available from the last 4 weeks since it is necessary to measure the postoperative change in haemoglobin and hematocrit.