Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
Status:
Completed
Trial end date:
2019-06-30
Target enrollment:
Participant gender:
Summary
Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide
accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of
death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery,
bleeding trauma patients, and menorrhagia.
The investigators seek to determine the efficacy of TXA in reducing PPH during and after
elective caesarean section.
Methods and Design The investigators intend to perform an open label randomized control study
of 1,162 women who are undergoing elective caesarean section. The participants will be
randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision
or not to receive the intervention. Prophylactic oxytocin will be administered to all the
women.
The primary outcome will be incidence of PPH defined by blood loss equal to or more than
1,000ml calculated by determining the difference in haematocrit values taken prior to and 48
hours after caesarean section.
Discussion In addition to prophylactic uterotonic administration, TXA is a complementary
component acting on the haemostatic process that can be used in the third stage of labour to
prevent PPH. It is a promising intervention that is cheap, easy to administer and would be
easy to add to routine delivery protocols in hospitals. It would also help to conserve
precious resources by reducing the need for blood products, and expensive surgical
interventions to manage PPH.
This large adequately powered randomized study seeks to determine the efficacy of TXA to
validate its routine use at caesarean section to prevent PPH.