Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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).
both groups will be given oxytocin as a standard management
Benha university hospital
Banhā, Banha, Egypt
RECRUITINGBenha University
Banhā, Banha, Egypt
ACTIVE_NOT_RECRUITINGVolume of blood loss
150 ml/pack
Time frame: 30 minutes after baby delivery
transfusion requirements
number of women transfused blood
Time frame: 7 days postpartum
additional medical intervention
number of patients were treated by an additional medical intervention
Time frame: 48 hours postpartum
additional surgical or radiological interventions to control bleeding
number of patients were treated by additional surgical or radiological intervention
Time frame: 7 days postpartum
Change in maternal hematocrit concentration
Hematocrit concentration (Percent)
Time frame: 48 hours postpartum
Tranexamic acid side effects
number of patients suffered from side effects
Time frame: 24 hours postpartum
thromboembolic events
number of patients suffered from thromboembolic events
Time frame: 7 days postpartum
Maternal death
Number of women will die.
Time frame: 7 days postpartum
Abubaker M Elnashar, MD
CONTACT
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