Postpartum Hemorrhage
Conditions
Keywords
Tranexamic acid, postpartum hemorrhage, cesarean section
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 during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: * Bleeding continues after 30 minutes * Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess efficacy of TXA in prevention of PPH and reduction of intra and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
Interventions
DRUGTranexamic Acid 100 milligram/Milliliter
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 during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: * Bleeding continues after 30 minutes * Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
DRUGOxytocin
both groups will be given oxytocin as a standard management
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model 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 during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: * Bleeding continues after 30 minutes * Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of blood loss | 30 minutes after baby delivery | 150 ml/pack |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| additional medical intervention | 48 hours postpartum | number of patients were treated by an additional medical intervention |
| additional surgical or radiological interventions to control bleeding | 7 days postpartum | number of patients were treated by additional surgical or radiological intervention |
| Change in maternal hematocrit concentration | 48 hours postpartum | Hematocrit concentration (Percent) |
| transfusion requirements | 7 days postpartum | number of women transfused blood |
| thromboembolic events | 7 days postpartum | number of patients suffered from thromboembolic events |
| Maternal death | 7 days postpartum | Number of women will die. |
| Tranexamic acid side effects | 24 hours postpartum | number of patients suffered from side effects |
Countries
Egypt
Contacts
Primary ContactAhmed A Morad, MD
Backup ContactAbubaker M Elnashar, MD
Outcome results
None listed