Placenta Previa
Conditions
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.
Interventions
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%
DRUGIntravenous 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of blood loss | during operation | amount of intraoperative blood loss during CS in patients with placenta previa |
Secondary
| Measure | Time frame |
|---|---|
| operative time | during operation |
Outcome results
None listed