Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid

NCT03706339 — Not applicable, Completed, 450 participants, Aswan University Hospital

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Reducing Blood Loss During Cesarean Section With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial

Registry	NCT03706339
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	450 (Actual)
Sponsor	Aswan University Hospital (Other)
Conditions	Cesarean Section Complications
Interventions	normal saline arm group, intravenous tranexamic acid, Topical tranexamic acid (Other, drug)
Dates	start 2018-11-01, primary completion 2020-03-31, completion 2020-08-01, first posted 2018-10-16, last updated 2020-08-05
Locations	1 site in Egypt

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
normal saline arm group	Placebo comparator	Other: 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
intravenous tranexamic acid group	Active comparator	Drug: 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
Topical tranexamic acid group	Experimental	Drug: 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

normal saline arm group (Other), also known as placebo comparator: 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
intravenous tranexamic acid (Drug), also known as active comparator: 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
Topical tranexamic acid (Drug), also known as active comparator: 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

+Outcome measures

Primary outcomes

intraoperative blood loss [during the operation]: measures the intraoperative blood loss by direct and gravimetric methods

Secondary outcomes

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]

+Eligibility

Sex: Female, ages: 20 Years to 45 Years

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

+Locations (1)

Facility	City	Country	Status
Aswan University	Aswān	Egypt

+Investigators

hany f sallam, md, Principal investigator, Aswan University Hospital

My Notes

Public

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