Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa

Not Applicable

Not yet recruiting

• Conditions: Placenta Previa
• Interventions: Drug: Topical tranexamic acid; Drug: Intravenous tranexamic acid

• Registration Number: NCT06515535
• Lead Sponsor: Cairo University

Brief Summary

Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.

Patients will be randomly assigned into two groups:

Group (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.

Group (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Study Start: 2024-07-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Age: 20-40 years old.
• BMI less than 30 kg/m2.
• Pregnancy of singleton living fetus.
• Placenta previa by ultrasound assessment
• Gestational age > 36 weeks.

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Exclusion Criteria

• Women with a history of any medical disorder with pregnancy, e.g., Gestational diabetes and hypertension.
• Women with systemic diseases, e.g., diabetes mellites, systemic immune disorders such as systemic lupus erythematosus
• Women with bleeding tendency or coagulopathy.
• Women on anticoagulants or hemodynamically unstable women.
• Women with uterine abnormalities, such as fibroids or polyps.
• Emergency termination of pregnancy.
• Intrauterine fetal death.
• Pregnancy with obstetric hemorrhage, e.g., antepartum hemorrhage
• Cases of placenta accrete spectrum disorder or placental abruption
• Women with known allergies to Tranexamic acid

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group (n=28)	Topical tranexamic acid	The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.
Study group (n=28)	Intravenous tranexamic acid	The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.
Control group (n=28)	Intravenous tranexamic acid	The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.

Primary Outcome Measures

Name	Time	Method
Amount of blood loss	during operation	amount of intraoperative blood loss during CS in patients with placenta previa

Secondary Outcome Measures

Name	Time	Method
operative time	during operation