Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid
- Conditions
- Cesarean Section Complications
- Interventions
- Drug: Topical tranexamic acidDrug: intravenous tranexamic acidOther: normal saline arm group
- Registration Number
- NCT03706339
- Lead Sponsor
- Aswan University Hospital
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 450
- all pregnant women with a single term fetus scheduled for elective cesarean section who will be at risk of postpartum hemorrhage
- Patients with a cardiac, hepatic, renal or thromboembolic disease. ,
- patients with the high possibility of the morbid adherent placenta,
- known coagulopathy and
- those presented with severe antepartum hemorrhage
- refuse to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical tranexamic acid group Topical tranexamic acid 2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 100 ml normal saline applied on the placental bed after Cesarean section plus110 ml normal saline IV just before skin incision intravenous tranexamic acid group intravenous tranexamic acid 1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus100 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the pelvic bed after Cesarean hysterectomy normal saline arm group normal saline arm group they received 110 ml saline infusion or placebo (110 normal salines) by slow intravenous injection at an approximate rate of 1 mL per min plus Throughout the operation irrigation was done by120 ml saline
- Primary Outcome Measures
Name Time Method intraoperative blood loss during the operation measures the intraoperative blood loss by direct and gravimetric methods
- Secondary Outcome Measures
Name Time Method postoperative blood loss 24 hours postoperative measurement the intraoperative blood loss by direct and gravimetric methods
need of blood transfusion 24 hours postoperative number of unites of blood transfusion
need of uterotonic during operation misoprostol,oxytocin etc
change in hemoglobin Baseline and 24 hours postoperative
Trial Locations
- Locations (1)
Aswan University
🇪🇬Aswan, Egypt