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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706339
• Other study ID #: aswu/278/7/18
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 1, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage

Intervention

Other:
• normal 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

Drug:
• intravenous 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
• Topical tranexamic acid
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

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative blood loss	measures the intraoperative blood loss by direct and gravimetric methods	during the operation
Secondary	postoperative blood loss	measurement the intraoperative blood loss by direct and gravimetric methods	24 hours postoperative
Secondary	need of blood transfusion	number of unites of blood transfusion	24 hours postoperative
Secondary	need of uterotonic	misoprostol,oxytocin etc	during operation
Secondary	change in hemoglobin		Baseline and 24 hours postoperative