Tranexamic Acid in Patients for Caesarian Delivery.
Status:
Active, not recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be
approved by the DUHS institutional review board (IRB) and the trial will be registered at
clinical trial registry. After receiving the trial information from the obstetricians during
prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both
the prospective women will be invited to participate in the trial. The intervention consists
of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline)
intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of
the delivery of baby, after the routine prophylactic uterotonic administration and cord
clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be
followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women
will be followed up at 48 hours after caeserian delivery. A venous blood sample will be
obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be
assessed until hospital discharge and by telephone interview at 8 weeks after delivery.