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

• Sponsor: Aswan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03706339
• Collaborator: (none)
• Enrollment: 450
• Location: 1
• Arms: 3
• Actual Duration (Months): 21
• Patients Per Site Per Month: 21.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications	Other: normal saline arm group; Drug: intravenous tranexamic acid; Drug: Topical tranexamic acid	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 450 participants
• 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 intraabdominalpatients 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)
• 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.
• Primary Purpose: Prevention
• Official Title: Reducing Blood Loss During Cesarean Section With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Mar 31, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	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; Other Names: placebo comparator
Active Comparator: intravenous tranexamic acid group 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	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; Other Names: active comparator
Experimental: Topical tranexamic acid group 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	Drug: 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; Other Names: active comparator

Outcome Measures

Primary Outcome Measures

1. intraoperative blood loss [during the operation]

   measures the intraoperative blood loss by direct and gravimetric methods

Secondary Outcome Measures

1. postoperative blood loss [24 hours postoperative]

   measurement the intraoperative blood loss by direct and gravimetric methods

2. need of blood transfusion [24 hours postoperative]

   number of unites of blood transfusion

3. need of uterotonic [during operation]

   misoprostol,oxytocin etc

4. change in hemoglobin [Baseline and 24 hours postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University	Aswan		Egypt	81528

Sponsors and Collaborators

• Aswan University Hospital

Investigators

• Principal Investigator: hany f sallam, md, Aswan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT03706339
• Other Study ID Numbers: aswu/278/7/18
• First Posted: Oct 16, 2018
• Last Update Posted: Aug 5, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by hany farouk, Principal Investigator, Aswan University Hospital: cesarean section; tranexamic acid; postpartum hemorrhage
• Additional relevant MeSH terms: Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Aug 5, 2020