SummaryBackgroundPost-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage.MethodsIn this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283.FindingsBetween March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus ...

Objectives: Compare the mean pain score with subcutaneous sterile water injection versus normal saline water injection over the sacrum in females presenting with severe back pain undergoing normal vaginal delivery at term. Study Design: Randomized Control Trial. Setting: MCH Centre, Pakistan Institute of Medical Sciences, Islamabad. Period: 21-08-2019 to 20-11-2019. Material & Methods: The non-probability, consecutive sampling technique was used to include patients. In group A, patients injection was given 4 intracutaneous injections of 0.5 ml sterile water in the lumbar- sacral region in the sitting position. One injection was given at the posterior superior iliac spine on both sides and second injection at 1 cm medial, and 1-2 cm inferior to the first point on both the sides using an insulin needle. These points overlie the area called Michaelis' rhomboid. In group B, patients were given injections of 0.5 ml isotonic saline in the same region using an insulin needle. Then patients were followed-up for 90 minutes (1.5hours). After 90 minutes, pain on VAS was again measured. Results: In this study the mean pain score at baseline of the patient was 79.82±12.99 and the mean pain score after the 90 minutes was 54.05±18.52. Statistically there is highly significant difference was found between the study groups and pain after 90 minutes of the patients i.e. p-value=0.000 Conclusion: Our study results concluded that sterile water group patients showed better pain relief as compared to normal saline group in in females presenting with severe back pain undergoing normal vaginal delivery at term.

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