Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707950
• Other study ID #: SEAbdelfattah
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2021
• Source: Benha University
• Contact: Ahmed A Morad, MD
• Phone: 0201224214435
• Email: awalid217[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Benha University	Banha	Banha
Egypt	Benha university hospital	Banha	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of blood loss	150 ml/pack	30 minutes after baby delivery
Secondary	transfusion requirements	number of women transfused blood	7 days postpartum
Secondary	additional medical intervention	number of patients were treated by an additional medical intervention	48 hours postpartum
Secondary	additional surgical or radiological interventions to control bleeding	number of patients were treated by additional surgical or radiological intervention	7 days postpartum
Secondary	Change in maternal hematocrit concentration	Hematocrit concentration (Percent)	48 hours postpartum
Secondary	Tranexamic acid side effects	number of patients suffered from side effects	24 hours postpartum
Secondary	thromboembolic events	number of patients suffered from thromboembolic events	7 days postpartum
Secondary	Maternal death	Number of women will die.	7 days postpartum