Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
Obstetrical hemorrhage accounts for nearly one quarter of all maternal deaths worldwide and
was the most common cause of maternal death in the Turkey [1,2]. Most of these deaths occur
within 4 h of delivery and are a result of problems during third and fourth stages of labor.
It also contributes significantly to serious maternal morbidity. Obstetric, surgical and
radiological interventions play central role in the management of obstetric hemorrhage;
however, pharmacologic management and in particular prohemostatic therapies also play an
important role in the final maternal outcome. Administration of tranexamic acid (TA),
intravenously in the third stage of labor may be one of these methods.
TA a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly
inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding.
TA may enhance the effectiveness of the patient's own hemostatic mechanism [3,4]. In
nonobstetric surgery, a systematic review of randomized controlled trails showed that
tranexamic acid reduced the risk of blood transfusion [ relative risk (RR) 0.61; 95% CI
0.54-0.69] and also reduced the need for re-operation as a result of bleeding (RR 0.67; 95%
CI 0.41-1.09). There was no evidence for an increased risk of thrombotic events [5].
In gynecology and obstetrics, TA is most commonly used to treat idiopathic menorrhagia, and
is an effective and well-tolerated treatment when administered orally [5,6,7]. Bleeding
associated with pregnancy (placental abruption, placenta previa) has also been treated with
TA [6]. Furthermore, four randomized controlled studies have shown that TA reduces postpartum
hemorrhage (PPH) following cesarean delivery [7-11]. Only one randomized trail is available
evaluating the effect of TA use to prevent bleeding in the postpartum period following
spontaneous vaginal delivery [12].
The purpose of our study was to estimate the effect of the addition of intravenous TA to a
standard active management of the third stage of labor (which includes prophylactic injection
of 10 IU of oxytocin within two minutes of birth, early clamping of the umbilical cord, and
controlled cord traction).