Clinical trial NCT04707950: Tranexamic Acid for the Prevention of Postpartum Haemorrhage
Official title: Use of Tranexamic Acid for the Prevention of Postpartum Haemorrhage After Cesarean Section in High-risk Patients ( a Randomized Control Trial ).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postpartum Hemorrhage
Keywords: Tranexamic acid
postpartum hemorrhage
cesarean section
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Volume of blood loss
timeFrame: 30 minutes after baby delivery
Secondary outcomes:
measure: transfusion requirements
timeFrame: 7 days postpartum
measure: additional medical intervention
timeFrame: 48 hours postpartum
measure: additional surgical or radiological interventions to control bleeding
timeFrame: 7 days postpartum
measure: Change in maternal hematocrit concentration
timeFrame: 48 hours postpartum
measure: Tranexamic acid side effects
timeFrame: 24 hours postpartum
measure: thromboembolic events
timeFrame: 7 days postpartum
measure: Maternal death
timeFrame: 7 days postpartum
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha university hospital
state: Banha
city: Banhā
country: Egypt
facility: Benha University
state: Banha
Study officials:
affiliation: Benha Faculty of Medecine
name: Abubaker M Elnashar, MD
role: PRINCIPAL_INVESTIGATOR
References: