A Phase 3 interventional study of transamin in Obstetrical Hemorrhage, sponsored by Erzincan Military Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-17.
Sponsored by Erzincan Military Hospital · Phase 3, Interventional, and Prevention
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).
Erzincan Military Hospital is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
TA administered intravenously over a 5 min period at delivery of the anterior shoulder
Drug: transamin
10 mL of saline was 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
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.
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.
Time frame: 2 hours
incidences of PPH >500 ml
The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 \> 500 mL
Time frame: 2 hours
the incidences of severe postpartum hemorrhage
The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05 ≥1000 ml
Time frame: 2 hours
need for additional uterotonic drugs
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
Time frame: 2 hours
side effects at time of TA injection
nausea, vomiting or diarrhea
Time frame: 2 hours
The record gives a start of Mar 2011, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Tranexamic Acid
Erzincan Military Hospital