Irene Ray1, Ratneshwar Bhattacharya2, Somajita Chakraborty1, Chiranjib Bagchi3, Sima Mukhopadhyay4. 1. Department of Obstetrics and Gynaecology, Medical College Kolkata, Kolkata, West Bengal India. 2. Department of Medicine, Icare Institute of Medical Science & Research and Dr. B. C. Roy Hospital, Haldia, West Bengal India. 3. Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal India. 4. Department of Obstetrics and Gynaecology, Icare Institute of Medical Sciences and Research and Dr. B. C. Roy Hospital, Haldia, West Bengal India.
Abstract
BACKGROUND: Post-partum haemorrhage (PPH) is a major cause of maternal mortality globally. Tranexamic acid, an anti-fibrinolytic agent, is a novel approach in an attempt to prevent this dreadful complication. This study aims to document the efficacy of intravenous (IV) tranexamic acid in reducing blood lossduring and after caesarean section (CS). METHODS: In this prospective randomised placebo-controlled open-label study, 100 mothers scheduled for elective CS were randomly selected and divided into two groups (study and control) of 50 each. The study group received 1 g IV tranexamic acid and the control group received IV placebo. Following delivery, all mothers received ten units of oxytocin in 500 ml of normal saline. RESULTS: The mean intra-operative and post-partum blood loss were significantly lower in the study group than the control group: 499.11 ± 111.2 and 59.93 ± 12.5 ml versus 690.85 ± 198.41 and 110.06 ± 13.47 ml, respectively, (p < 0.001). Total blood loss was 30 % less in the study group (p < 0.001). Six mothers had PPH in the control group, while none in the study group. The difference between the pre-operative and post-operative haemoglobin levels was significantly less in the study group than the control group, 0.26 ± 0.22 versus 0.99 ± 0.48 g% (p < 0.001).There was no significant difference with respect to other haematological parameters. There was no added adverse effect or need for NICU admission in the study group. CONCLUSION: Pre-operative IV tranexamic acid significantly reduced blood loss during elective CS without any significant adverse effects.
RCT Entities:
BACKGROUND: Post-partum haemorrhage (PPH) is a major cause of maternal mortality globally. Tranexamic acid, an anti-fibrinolytic agent, is a novel approach in an attempt to prevent this dreadful complication. This study aims to document the efficacy of intravenous (IV) tranexamic acid in reducing blood loss during and after caesarean section (CS). METHODS: In this prospective randomised placebo-controlled open-label study, 100 mothers scheduled for elective CS were randomly selected and divided into two groups (study and control) of 50 each. The study group received 1 g IV tranexamic acid and the control group received IV placebo. Following delivery, all mothers received ten units of oxytocin in 500 ml of normal saline. RESULTS: The mean intra-operative and post-partum blood loss were significantly lower in the study group than the control group: 499.11 ± 111.2 and 59.93 ± 12.5 ml versus 690.85 ± 198.41 and 110.06 ± 13.47 ml, respectively, (p < 0.001). Total blood loss was 30 % less in the study group (p < 0.001). Six mothers had PPH in the control group, while none in the study group. The difference between the pre-operative and post-operative haemoglobin levels was significantly less in the study group than the control group, 0.26 ± 0.22 versus 0.99 ± 0.48 g% (p < 0.001).There was no significant difference with respect to other haematological parameters. There was no added adverse effect or need for NICU admission in the study group. CONCLUSION: Pre-operative IV tranexamic acid significantly reduced blood loss during elective CS without any significant adverse effects.
Authors: Everett F Magann; Sharon Evans; Maureen Hutchinson; Robyn Collins; Grainger Lanneau; John C Morrison Journal: South Med J Date: 2005-07 Impact factor: 0.954