Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Study Overview
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Brief Summary
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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
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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).

Official Title
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Use of Tranexamic Acid for the Prevention of Postpartum Haemorrhage After Cesarean Section in High-risk Patients ( a Randomized Control Trial ).

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: Tranexamic Acid 100 milligram/Milliliter
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group will be given tranexamic acid<br>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). | Drug: Tranexamic Acid 100 milligram/Milliliter<br>* 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).<br>* Other names: Study group;Drug: Oxytocin<br>* both groups will be given oxytocin as a standard management<br>* Other names: Control group;|
| Placebo Comparator: Control group<br>The control group will not be given Tranexamic acid but only the standard management ( Oxytocin ) | Drug: Oxytocin<br>* both groups will be given oxytocin as a standard management<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of blood loss | 150 ml/pack | 30 minutes after baby delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion requirements | number of women transfused blood | 7 days postpartum | 
| additional medical intervention | number of patients were treated by an additional medical intervention | 48 hours postpartum | 
| additional surgical or radiological interventions to control bleeding | number of patients were treated by additional surgical or radiological intervention | 7 days postpartum | 
| Change in maternal hematocrit concentration | Hematocrit concentration (Percent) | 48 hours postpartum | 
| Tranexamic acid side effects | number of patients suffered from side effects | 24 hours postpartum | 
| thromboembolic events | number of patients suffered from thromboembolic events | 7 days postpartum | 
| Maternal death | Number of women will die. | 7 days postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, postpartum hemorrhage, cesarean section