Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Phase 1

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Tranexamic Acid 100 milligram/Milliliter; Drug: Oxytocin

• Registration Number: NCT04707950
• Lead Sponsor: Benha University

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).

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-25
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13
• Primary Completion: 2021-02-25
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group will be given tranexamic acid	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).
study group will be given tranexamic acid	Oxytocin	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).
Control group	Oxytocin	The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )

Primary Outcome Measures

Name	Time	Method
Volume of blood loss	30 minutes after baby delivery	150 ml/pack

Secondary Outcome Measures

Name	Time	Method
Tranexamic acid side effects	24 hours postpartum	number of patients suffered from side effects
Maternal death	7 days postpartum	Number of women will die.
additional medical intervention	48 hours postpartum	number of patients were treated by an additional medical intervention
transfusion requirements	7 days postpartum	number of women transfused blood
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)
thromboembolic events	7 days postpartum	number of patients suffered from thromboembolic events

Trial Locations

Locations (2)

Benha university hospital; 🇪🇬 Banhā, Banha, Egypt

Benha University; 🇪🇬 Banhā, Banha, Egypt