Tranexamic Acid for the Prevention of Postpartum Haemorrhage
NCT ID: NCT04707950
Last Updated: 2021-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2020-01-01
2021-03-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
PREVENTION
NONE
Study Groups
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study group will be given tranexamic acid
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).
Tranexamic 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).
Oxytocin
both groups will be given oxytocin as a standard management
Control group
The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )
Oxytocin
both groups will be given oxytocin as a standard management
Interventions
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Tranexamic 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).
Oxytocin
both groups will be given oxytocin as a standard management
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Benha University
OTHER
Responsible Party
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Dr. Abou Bakr Mohamed El Nashaar
Professor
Principal Investigators
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Abubaker M Elnashar, MD
Role: PRINCIPAL_INVESTIGATOR
Benha Faculty of Medecine
Locations
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Benha university hospital
Banhā, Banha, Egypt
Benha University
Banhā, Banha, Egypt
Countries
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Central Contacts
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Abubaker M Elnashar, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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SEAbdelfattah
Identifier Type: -
Identifier Source: org_study_id
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