NCT01338454

Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Erzincan Military Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Conditions

• Obstetrical Hemorrhage

Interventions

Type	Name	Description
DRUG	transamin	TA was administered intravenously over a 5 min period at delivery of the anterior shoulder

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-04-19
• Last updated: 2011-11-17

Locations

1 site across 1 country: Turkey (Türkiye)