Cesarean Section Complications
Conditions
Keywords
cesarean section, tranexamic acid, postpartum hemorrhage
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
Interventions
OTHERnormal saline arm group
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
DRUGintravenous tranexamic acid
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
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used.
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
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* all pregnant women with a single term fetus scheduled for elective cesarean section who will be at risk of postpartum hemorrhage
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | during the operation | measures the intraoperative blood loss by direct and gravimetric methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Egypt
Outcome results
None listed