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Completed

NCT Number: NCT03706339

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

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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Key information

Conditions

Cesarean Section Complications Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline arm group

Other

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

Intravenous tranexamic acid

Drug

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

Topical tranexamic acid

Drug

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

Primary outcomes

  1. intraoperative blood loss

    Time frame: during the operation

    measures the intraoperative blood loss by direct and gravimetric methods

Secondary outcomes

  1. postoperative blood loss

    Time frame: 24 hours postoperative

    measurement the intraoperative blood loss by direct and gravimetric methods

  2. need of blood transfusion

    Time frame: 24 hours postoperative

    number of unites of blood transfusion

  3. need of uterotonic

    Time frame: during operation

    misoprostol,oxytocin etc

  4. change in hemoglobin

    Time frame: Baseline and 24 hours postoperative

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 16, 2018
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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