Clinical trial NCT01338454: Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstetrical Hemorrhage
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: Inclusion Criteria:

* gestational age between 37 and 42 weeks,
* live fetus,
* cephalic presentation,
* vaginal birth.
* Patients who had a risk factors for PPH, such as multiple gestation, polyhydramnios, fetal macrosomia, antepartum hemorrhage, anemia (haemoglobin concentration \< 8 g/dL), severe pre-eclampsia, or coagulopathy

Exclusion Criteria:

* placenta previa,
* placental abruption,
* cesarean section or any uterine scar, abnormal placentation (accreta, increta, or percreta),
* a current or previous history of significant disease, including heart disease, liver, renal disorders.

Primary outcomes:
measure: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor.
timeFrame: 2 hours
Secondary outcomes:
measure: incidences of PPH >500 ml
timeFrame: 2 hours
measure: the incidences of severe postpartum hemorrhage
timeFrame: 2 hours
measure: need for additional uterotonic drugs
timeFrame: 2 hours
measure: side effects at time of TA injection
timeFrame: 2 hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bakıryok Women and Children Hospital
state: Bakırkoy
Study officials:
References:
citation: Gungorduk K, Asicioglu O, Yildirim G, Ark C, Tekirdag AI, Besimoglu B. Can intravenous injection of tranexamic acid be used in routine practice with active management of the third stage of labor in vaginal delivery? A randomized controlled study. Am J Perinatol. 2013 May;30(5):407-13. doi: 10.1055/s-0032-1326986. Epub 2012 Sep 21.