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

NCT06515535 | Not Yet Recruiting

• 1 other identifier: MS-201-2024
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• Amount of blood loss

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

  during operation

Secondary Outcomes (1)

• operative time

  during operation

Study Arms (2)

Study group (n=28)

EXPERIMENTAL

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.

Drug: Topical tranexamic acid; Drug: Intravenous tranexamic acid

Control group (n=28)

ACTIVE COMPARATOR

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.

Drug: Intravenous tranexamic acid

Interventions

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%

Study group (n=28)

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.

Control group (n=28); Study group (n=28)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Placenta Previa

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obgyn Cairo university

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: July 24, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07