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 ...

Objective: To quantify differences in assessing preterm delivery when calculating gestational age from last menstrual period (LMP) versus ultrasonography biometry. Methods: The Zambian Preterm Birth Prevention Study is an ongoing prospective cohort study that commenced enrolment in August 2015 at Women and Newborn Hospital of University Teaching Hospital in Lusaka, Zambia. Women at less than 20 weeks of pregnancy who were enrolled between August 17, 2015, and August 31, 2017, and underwent ultrasonography examination were included in the present analysis. The primary outcome was the difference between ultrasonography- and LMP-based estimated gestational age. Associations between baseline predictors and outcomes were assessed using simple regression. The proportion of preterm deliveries using LMP- and ultrasonography-derived gestational dating was calculated using Kaplan–Meier analysis. Results: The analysis included 942 women. The discrepancy between estimating gestational age using ultrasonography and LMP increased with greater gestational age at presentation and among patients with no history of preterm delivery. In a Kaplan–Meier analysis of 692 deliveries, 140 (20.2%, 95% confidence interval [CI] 17.7–23.0) and 79 (11.4%, 95% CI 9.6–13.6) deliveries were classified as preterm by LMP and ultrasonography estimates, respectively. Conclusion: Taking ultrasonography as a standard, a bias was observed in LMP-based gestational age estimates; these increased with advancing gestation at presentation. This resulted in misclassification of term deliveries as preterm.

Objective: To map the cervical cancer screening cascade among women living with HIV attending a public-sector cytology screening program in Johannesburg, South Africa. Methods: We conducted a retrospective cohort study of routinely collected clinical data captured in an electronic medical record system. Women (≥18 years) living with HIV with an abnormal Pap result between January 2013 and May 2018 were included. The proportion of women who received follow-up consistent with extant clinical guidelines, stratified by their initial Pap smear result, was examined. Results: The study included 2072 women: 1384 (66.8%) with a low-risk Pap result, 681 (32.9%) with a high-risk Pap result, and 7 (0.3%) with suspected cancer. Only 174 (25.6%) women with a high-risk Pap result underwent guideline-indicated management within 18 months. Among women with a low-risk Pap result, 375 (27.1%) received follow-up within 1 year; the cumulative incidence of follow-up increased to 63.1% at 3 years. All women with suspected cancer either received a colposcopic biopsy or were referred for further treatment. Conclusion: Attrition among South African women living with HIV who attended cervical screening in an urban public-sector program was high. Developing tailored interventions to address bottlenecks in the care cascade and improve cervical screening outcomes will be central to eliminating cervical cancer.

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