In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process further by inhibiting the fibrinolytic system. TXA is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and recent evidence have found promising results in its use for prophylaxis of PPH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision
KK Women's and Children's Hospital
Singapore, Singapore
Estimated blood loss
This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.
Time frame: Intraoperative
Change in hemoglobin and hematocrit level
Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery
Time frame: Preoperative to 48 hours postoperative
Need for additional medical intervention including blood transfusion, additional uterotonics
Time frame: During surgery and up to 3 days after surgery
Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery
Time frame: During surgery and up to 24 hours from surgery
Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism
Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery.
Time frame: Intraoperative to 4 weeks post surgery
Neonatal APGAR score
Neonatal APGAR score at 1 and 5 minutes of life
Time frame: At delivery
Neonatal birth weight
Time frame: At delivery
Neonatal admission to special care nursery or intensive care unit
Time frame: At delivery
Diagnosis of thromboembolic events in the neonate
Time frame: Up to 4 weeks post delivery
Gravimetric estimation of blood loss during the surgery
This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted
Time frame: Intraoperative
Provider estimated blood loss
Estimated by the surgical team
Time frame: Intraoperative
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