Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Pr… (NCT06515535) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa
56 participantsStarted 2024-07-24
Plain-language 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.
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.