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

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.

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Key information

Conditions

Placenta Previa Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Topical tranexamic acid

Drug

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

Drug

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.

Primary outcomes

Amount of blood loss

Time frame: during operation

amount of intraoperative blood loss during CS in patients with placenta previa

Secondary outcomes

operative time

Time frame: during operation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During Elective Cesarean Delivery in Patients With Placenta Previa

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 23, 2024
Registry last updated: Jul 23, 2024

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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