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 ...

HAART given to HIV-infected mothers in late pregnancy and during breastfeeding resulted in a low postnatal HIV transmission similar to that previously demonstrated in the Mitra study in Dar es Salaam using infant prophylaxis with 3TC during breastfeeding. The extended maternal prophylaxis with HAART for prevention of mother-to-child transmission of HIV-1 for breastfeeding mothers who do not need HAART for their own health should be further evaluated and compared with the use of infant postnatal antiretroviral prophylaxis regarding safety and cost-effectiveness.

BackgroundIn a study of prevention of mother-to-child transmission of HIV (PMTCT) by triple antiretroviral therapy (ART) in Dar es Salaam, Tanzania (the Mitra Plus study), retrospective viral load testing revealed a high and increasing frequency of detectable viral load during follow-up for two years postnatally in women given continuous ART for their own health suggesting poor adherence. This study explored women’s own perceived barriers to adherence to ART post-delivery so as to identify ways to facilitate better drug adherence among women in need of ART for their own health.MethodsSemi-structured interviews were conducted with 23 of the 48 women who had detectable viral load at 24 months postnatally. Content analysis was used to analyze the data.ResultsMost women in the study did not acknowledge poor adherence until confronted with the viral load figures. Then, however, they revealed multiple reasons for failing to adhere. They said that their motivation to take ART decreased once they had protected their children from becoming infected and successfully weaned them. Feeling well for some, and a feeling of hopelessness for others, also decreased motivation to continue ART. The overwhelming demands of everyday life, poverty and lack of empowerment also posed significant barriers to long-term adherence. The need to keep their HIV status a secret and not let anyone see them taking the drugs was another steep barrier.ConclusionReasons for postnatal failure to adhere by mothers put on ART for life during pregnancy included lack of motivation to continue ART after weaning the child, poverty and stigma. Projects that simultaneously address stigma, poverty and women’s lack of empowerment may be necessary for PMTCT and ART to reach their full potential. Our results indicate that the new WHO proposal to start all HIV-infected pregnant women on lifelong ART regardless of CD4 cell count needs to address the challenging realities of women in resource-poor contexts if it is to be successful.