Tranexamic (TXA)acid is an inexpensive, antifibrinolytic drug long used to control bleeding due to surgery, menorrhagia, or trauma. Additionally, tranexamic acid has been shown to reduce bleeding during cesarean delivery as well as the need for additional uterotonic agents, albeit to a minimal degree. However, previous studies have been performed only in women with a standard risk for postpartum hemorrhage( PPH) and have not focused on assessing the effects of tranexamic acid in high-risk women. The aim of this study is to evaluate the efficacy of IV versus topical application of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is topical application of Tranexamic acid effective in reducing blood loss during and after an elective Caesarean section? The Research Hypothesis the TXA could be able to reduce blood loss during and after elective Caesarean section. The null hypothesis will, therefore, state that: There will be no difference between topical and IV TXA and placebo in reducing blood loss during and after elective Caesarean section.
patients were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min. Throughout the operation, irrigation was done by 60 ml of (2g tranexamic acid (10 ml) diluted in 100 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.).At the end of operation, another dose of 60 ml of (1g tranexamic acid (10 ml) diluted in 50 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.) was left intraabdominal
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
450
110 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the placental bed during Cesarean section
1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus110 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the pelvic bed during cesarean section
2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 120 ml normal saline applied on the pelvic bed during cesarean section plus110 ml normal saline IV just before skin incision
Aswan University
Aswān, Egypt
intraoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods
Time frame: during the operation
postoperative blood loss
measurement the intraoperative blood loss by direct and gravimetric methods
Time frame: 24 hours postoperative
need of blood transfusion
number of unites of blood transfusion
Time frame: 24 hours postoperative
need of uterotonic
misoprostol,oxytocin etc
Time frame: during operation
change in hemoglobin
Time frame: Baseline and 24 hours postoperative
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