Can we Use Intravenous Injection of Tranexamic Acid in Routine Practice With Active Management of the Third Stage of Labor?
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|ClinicalTrials.gov Identifier: NCT01338454|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : November 17, 2011
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 .
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 . 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 .
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).
|Condition or disease||Intervention/treatment||Phase|
|Obstetrical Hemorrhage||Drug: transamin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Active Comparator: tranexamic acid
TA administered intravenously over a 5 min period at delivery of the anterior shoulder
TA was administered intravenously over a 5 min period at delivery of the anterior shoulder
No Intervention: saline
10 mL of saline was administered intravenously over a 5 min period at delivery of the anterior shoulder
- 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. [ Time Frame: 2 hours ]The volume of blood loss was measured by weighing a sheet soaked from the end of the delivery to 2h after birth. We used a specially designed operating sheet and an electronic scale to weigh all the material (with a 1 g deviation range). The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05.
- incidences of PPH >500 ml [ Time Frame: 2 hours ]The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 > 500 mL
- the incidences of severe postpartum hemorrhage [ Time Frame: 2 hours ]The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 ≥1000 ml
- need for additional uterotonic drugs [ Time Frame: 2 hours ]need for additional uterotonic drugs such as 200 µg intravenous metylergometrine, 20 IU oxytocin infusion in 500 ml ringer lactate, and/or 800 misoprostol rectally for vaginal bleeding
- side effects at time of TA injection [ Time Frame: 2 hours ]nausea, vomiting or diarrhea
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338454
|Bakıryok Women and Children Hospital|
|İstanbul, Bakırkoy, Turkey, 34142|