Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa
NCT ID: NCT06515535
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2024-07-24
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Topical tranexamic acid
Topical tranexamic acid will be applied after placental delivery 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%
Intravenous tranexamic acid
Intravenous tranexamic acid will be given in the form of 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.
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.
Intravenous tranexamic acid
Intravenous tranexamic acid will be given in the form of 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.
Interventions
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Topical tranexamic acid
Topical tranexamic acid will be applied after placental delivery 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%
Intravenous tranexamic acid
Intravenous tranexamic acid will be given in the form of 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.
Eligibility Criteria
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Inclusion Criteria
* BMI less than 30 kg/m2.
* Pregnancy of singleton living fetus.
* Placenta previa by ultrasound assessment
* Gestational age \> 36 weeks.
Exclusion Criteria
* 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
20 Years
40 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Abdalla Mousa
Lecturer of obgyn Cairo university
Other Identifiers
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MS-201-2024
Identifier Type: -
Identifier Source: org_study_id
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