Tranexmic Acid and reducing blood loss after Vaginal Delivery: A randomized controlled trial

Abstract

Primary post-partum hemorrhage (PPH) is defined as blood loss greater than or equal to 500 ml within 24 hours after birth, while severe PPH is blood loss greater than or equal to 1000 ml within 24 hours. According to national statistics in Egypt, hemorrhage before and after delivery was the leading direct cause of maternal death (43%), with most hemorrhage deaths due to postpartum hemorrhage. There were 32 maternal deaths with hemorrhage per 100,000 live births for other causes were much less than hemorrhage (e.g. hypertensive diseases were 18 per 100,000, for sepsis 7 per 100,000, for ruptured uterus 7 per 100,000, for cesarean section 6 per 100,000, for obstructed labor 4 per 100,000, for cardiac disease 11 per 100,000 and for anemia 9 per 100,000). The increased frequency of PPH in the developing world is mainly due to expectant management because of lack of availability of medications used in the active management of the third stage of labor. Thus this study was held on the steps of previous studies to assess the efficacy of addition of Tranexmic Acid (TXA) to the active management of the third stage of labor (AMTSL) in reducing the amount of blood loss during normal vaginal delivery. This randomized double blinded prospective case control trial was conducted at Ain Shams University Maternity Hospital. It was conducted on 160 pregnant women who underwent normal vaginal delivery. All the included patientsages from 18 years to 40 years, gestational age between 37 and 42 weeks, single living fetus and cephalic presentation. In the current study we excluded patients who have risk factors for PPH, such as (multiple gestation, polyhydramnios, fetal macrosomia, antepartum hemorrhage, severe anemia, severe pre-eclampsia, placental abruption, grandmultipara, coagulopathy or prolonged labor), patients with history of venous or arterial thrombosis, patients with any known cardiovascular, renal, or liver disorders, in utero fetal death, patients who were given low-molecular-weight heparin or anti-platelet agents during the week before delivery, cesarean section or any uterine scar, abnormally invasive placenta or placenta previa, patients with history of epilepsy or seizure or patients with an autoimmune disease.

Patients were randomized and divided into 2 groups: Group A (study group)included 80 patients that received the standard AMTSL + Tranexmic Acid (Kapron, Amoun, Egypt 1 gm IV) in the 2 min after baby`s delivery. Group B (control group) included 80 patients that received the standard AMTSL+ placebo treatment similar to Tranexmic acid (Saline). AMSTL is administration of oxytocin 10IU IV immediately after delivery of the anterior shoulder, early cord clamping and cutting and controlled cord traction (CCT) will be done to both groups. Except for the content of the study drug vial, all aspects of management of the third stage were identical in both groups. Observation of both groups in the first 24 hours was done as followed: Observation of occurrence of PPH estimation of blood loss during delivery (Soaked towel 150cc, Non soaked towel 100cc) after delivery (Soaked dressing 50cc, Non soaked dressing 30cc). Vital Data "pulse & blood pressure" was recorded after the 1st, 6th and 24 hours. Hemoglobin & Hematocrit were measured and recorded before delivery and 24 hours after delivery. The Need for further medical interventions to stop PPH (Ecobolics), blood transfusion, surgical intervention (B lynch, hysterectomy) and ICU admission was recorded.