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

Antenatal contraception - simple, feasible, but is it safe and ethical in resource-poor environments?

In developing countries, antenatal care is used by more women than any other reproductive health services available and many women who receive antenatal care will not receive intrapartum care by a trained provider and even fewer will receive postnatal care. At present, antenatal care provides contraceptive counselling but not contraceptive provision. An important reason for this is the perceived absence of a suitable method that could be distributed or started during antenatal care. In this article, we discuss the available options. We conclude that antenatal insertion of subdermal contraceptive implants is very likely to be safe and ethically defensible where access to contraceptive services is poor

Facteurs de risques de la rupture prématurée des membranes entre 28 et 34 semaines d’aménorrhée dans un hôpital universitaire au Burkina

L’objectif était d’étudier les différents aspects de la rupture prématurée des membranes dans un contexte de pays à ressources limitées. Il s'est agi d'une étude prospective et descriptive à visée analytique, sur une période de 12 mois, dans le département de Gynécologie, d'Obstétrique et de Médecine de la Reproduction du Centre Hospitalier Universitaire Souro Sanou de Bobo-Dioulasso au Burkina Faso. Elle a concerné les gestantes reçues dans notre département chez qui le diagnostic de rupture prématurée des membranes (RPM), sur des grossesses de 28 à 34 semaines d'aménorrhée, a été confirmé à l'issue de l'examen clinique. Nous avons enregistré 38 cas de rupture prématurée des membranes pour 5024 accouchements soit une fréquence de 0,75 %. Ces gestantes étaient surtout jeunes, primipares, femmes au foyer, non alphabétisées, ayant fait peu de consultations prénatales. Les antécédents de ces patientes ont été marqués par des cas de ruptures prématurées des membranes et d'avortement. Ces patientes présentaient en outre soit des infections urogénitales, des présentations irrégulières, des distensions utérines et/ ou un placenta prævia. Cela nous a permis ainsi d’identifier un groupe de femmes que l’on pourrait dans une certaine mesure qualifier de groupe à risque de rupture prématurée des membranes dans notre département. La présence de certains éléments cliniques et paracliniques chez ces patientes, nous a permis d’identifier ce qu’on pourrait appeler des femmes à risque de rupture prématurée des membranes.Mots-clés: ruptures prématurées des membranes - facteurs de risques - consultations prénatalesEnglish Title: Risk factors for premature rupture of membranes between 28 and 34 weeks of amenorrhea in a Teaching University hospital in Burkina FasoEnglish AbstractThe objective was to study the different risk factors for premature rupture of membranes in a context of resource-limited countries. This was a prospective and descriptive study for an analytical purpose, over a period of 12 months, in the Department of Gynecology, Obstetrics and Reproductive Medicine of the Souro Sanou University Hospital Center in Bobo-Dioulasso. Burkina Faso. It concerned the pregnant women received in our department, whose diagnosis of rupture of the membranes before any work began, in pregnancies of 28 to 34 weeks of amenorrhea, was confirmed after the clinical examination. We recorded 38 cases of premature rupture of membranes for 5024 deliveries or a frequency of 0.75%. These patients were young, primiparious, housewives, having made little prenatal consultations. The antecedents of these patients have been marked by cases of premature rupture of the membranes, and abortion. Other risk factors included irregular presentations, placenta previa and urogenital infections, which identified a group of women at risk of premature rupture of the membranes.Keywords: premature rupture of membranes - risk factors - prenatal consultatio