Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

Background Post-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. Methods In 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. Findings Between 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 placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation

Barriers and Facilitators to the recruitment of Black African women for research in the UK: Hard to engage and not hard to reach

Background: Black African women living in the United Kingdom suffer from inequalities in health, care and maternity outcomes compared with their counterparts. Their presence has however been found to be lacking in life-saving healthcare research. As a result of a lack of engagement in healthcare research, some authors have classified them as “hard to reach”. However, in order to reduce the health inequalities experienced by this group, methods for engagement that would suit this population group would need to be explored. Therefore, this study set out to present an ethnic specific perspective of the barriers and facilitators to the recruitment of black African women to research from the researcher’s perspective. Method: Two studies were conducted aimed at the recruitment of Black African women in healthcare research. Proposed recruitment strategies included snowballing, social media (twitter, Facebook), flyers and collaboration with gatekeepers in two NHS trusts in London. The strategies were developed based on a review of literature, best practice ethics guidelines and consultations with experts in the field. Results: Successful recruitment strategies included snowball sampling, word of mouth, peer to peer recruitment and the use of influential members in the community. Existing recruitment strategies were found to be unsuitable to properly engage members of this community. In addition to this, ethical guidelines around informed consent and gatekeeping seem to impede the successful engagement of the members of this community. Conclusion: Proper methods of engagement are required to bridge the inequality gap. Therefore, it is important that ethical procedures, processes, and recruitment methods be reviewed such that it will take into consideration the cultural peculiarities of individuals within this community

Kinetics and mechanism of the reduction of dodecatungstocobaltate (III) by -aqueous solutions of L-methionine

BuII. Chem. Soc. Ethiop. 1992, 6(2) 75-80

Kinetics and mechanism of the reduction of dodecatungstocobaltate (III) by -aqueous solutions of L-methionine

BuII. Chem. Soc. Ethiop. 1992, 6(2) 75-80