A randomised controlled trial of tranexamic acid versus misoprostol in reducing blood loss during caesarean section

一项关于氨甲环酸与米索前列醇在减少剖宫产术中出血量的随机对照试验

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Abstract

OBJECTIVE: To determine the efficacy of intravenous tranexamic acid versus rectal misoprostol in decreasing intraoperative blood loss during caesarean section (C/S). DESIGN AND SETTING: Randomised controlled study involving pregnant women undergoing C/S at Alex Ekwueme Federal University Teaching Hospital, Abakaliki in Nigeria. PARTICIPANTS AND INTERVENTIONS: Five hundred and fourteen women undergoing elective C/S were assigned randomly (257 patients per group) to receive either pre-operative 1000 µg rectal misoprostol or 1000mg intravenous tranexamic acid after spinal anaesthesia. Data from 248 patients were analysed in the misoprostol group, while data from 250 patients were analysed in the tranexamic acid group. Sixteen patients were excluded from analysis; nine had incompletely filled proforma, while seven were lost to follow-up. MAIN OUTCOME: Intraoperative blood loss. RESULTS: The mean intraoperative blood loss was not significantly different between the misoprostol group and the tranexamic acid group (547 ± 183.75ml vs. 551.66 ± 21.74ml, P = 0.157). The mean difference in pack cell volume (PCV) changes was not significant between the groups (2.41±0.95% vs. 2.36±0.56%, P = 0.474). The side effects profile was similar for both groups except for shivering, which was statistically higher among the misoprostol group (RR = 0.70; 95%CI 0.40 - 0.91, P = 0.028). CONCLUSION: Intravenous tranexamic acid was comparable to rectal misoprostol in the reduction of blood loss during C/S. Tranexamic acid could act as a good alternative to misoprostol for prophylaxis for blood loss during elective C/S. FUNDING: None declared.

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