Objective: To compare the tranexamic acid effectiveness and safety with placebo for prevention of post partum hemorrhage (PPH) on general population of Lahore.
Study Design: Randomized double blind placebo control trial.
Place and Duration of Study: This study was conducted over a period of two years and six month (Jan 2015 to Jun 2017) in Ranger Hospital and Cavalry Hospital Lahore.
Material and Methods: A total 600 cases were randomly selected from obstetric outpatient departments of both hospitals for delivery. Patients were divided in two groups, 300 patients received tranexamic acid and 300 patients received placebo. In tranxamic acid group, in cases of vaginal deliveries a loading dose of 01 gram tranexamic acid was injected intravenously at delivery of anterior shoulder. In cases of lower segment caesarean section it was administered intravenously prior to abdominal incision. Those patients who failed to response, a second dose of 01 gram tranxamic acid were repeated at 30 minutes - 01 hour interval. In similar manner placebo was injected in second group.
Results: In tranexamic acid group, 289 (96%) patients responded successfully. Second dose was needed in 8 patients. Out of these 8 cases, 4 patients responded successfully. Those 4 women who failed to respond to tranxamic acid, 2 patients had venous thrombosis, 1 case was of placenta increate and 1 case was of uterine atony. Life saving total abdominal hysterectomy was performed in case of placenta increate. The patient of uterine atony required surgical intervention. In this study tranexamic acid administration was associated with reduction in blood loss after vaginal delivery 88.2 ± 15.5 mlversus 300 ± 35 ml in placebo group, and was significantly effective (p<0.001). In case of caesarean sections, blood loss was reduced 153.2 ± 21 ml in tranexamic acid group versus 745 ± 72.5 ml in placebo. The reduction was significant (p<0.001). Minor gastrointestinal side effects were common after tranexamic acid use. Thromboembolic events were same in both groups.
Conclusion: Tranexamic acid effectively reduced post-partum blood loss along utro-tonics. Tranexamic acid is a safe drug which can reduce the primary PPH along with utrotonics.
Keywords : Caesarean section, Primary postpartum hemorrhage, Tranexamic acid, Vaginal delivery.