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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Placenta Previa

Treatments: Drug: Intravenous tranexamic acid; Drug: Topical tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06515535

MS-201-2024

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Study group (n=28)

Experimental group

Description:

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.

Treatment:

Drug: Topical tranexamic acid

Drug: Intravenous tranexamic acid

Control group (n=28)

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous tranexamic acid