Status:
UNKNOWN
Tranexamic Acid for the Prevention of Postpartum Haemorrhage
Lead Sponsor:
Benha University
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).
Detailed Description
Participants will be divided into two groups: a study group \& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion d...
Eligibility Criteria
Inclusion
- 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
- Age less than 18 years.
- Women who are not at high risk for PPH.
- Women attending for normal vaginal delivery.
- Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease.
- Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated.
- Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis.
- 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
- Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA.
- Hypersensitivity to TXA or any of its ingredients.
- 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
- Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures..
- Active cancer, because of the risk of thromboembolism.
- Congestive heart failure requiring treatment, because of the risk of thrombosis.
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04707950
Start Date
January 1 2020
End Date
March 30 2021
Last Update
January 13 2021
Active Locations (2)
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1
Benha university hospital
Banhā, Banha, Egypt, 13511
2
Benha University
Banhā, Banha, Egypt, 13511