Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid
Condition: Cesarean Section Complications
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): normal saline arm group; intravenous tranexamic acid; Topical tranexamic acid
Intervention type(s): Other; Drug; Drug
Intervention description(s): 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
Other intervention name(s): placebo comparator; active comparator; active comparator
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cesarean section; tranexamic acid; postpartum hemorrhage