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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 ...

BackgroundRising caesarean section (CS) rates have been observed worldwide in recent decades. This study sought to analyse trends in CS rates and outcomes among a variety of obstetric groups at a university hospital in a low-income country.MethodsWe conducted a hospital-based panel study at Muhimbili National Hospital, Dar es Salaam, Tanzania. All deliveries between 2000 and 2011 with gestational age ≥ 28 weeks were included in the study. The 12 years were divided into four periods: 2000 to 2002, 2003 to 2005, 2006 to 2008, and 2009 to 2011. Main outcome measures included CS rate, relative size of obstetric groups, contribution to overall CS rate, perinatal mortality ratio, neonatal distress, and maternal mortality ratio. Time trends were analysed within the ten Robson groups, based on maternal and obstetric characteristics. We applied the χ2 test for trend to determine whether changes were statistically significant. Odds ratios of CS were evaluated using multivariate logistic regression, accounting for maternal age, referral status, and private healthcare insurance.ResultsWe included 137,094 deliveries. The total CS rate rose from 19% to 49%, involving nine out of ten groups. Multipara without previous CS with single, cephalic pregnancies in spontaneous labour had a CS rate of 33% in 2009 to 2011. Adjusted analysis explained some of the increase. Perinatal mortality and neonatal distress decreased in multiple pregnancies (p < 0.001 and p = 0.003) and nullipara with breech pregnancies (p < 0.001 and p = 0.024). Although not statistically significant, there was an increase in perinatal mortality (p = 0.381) and neonatal distress (p = 0.171) among multipara with single cephalic pregnancies in spontaneous labour. The maternal mortality ratio increased from 463/100, 000 live births in 2000 to 2002 to 650/100, 000 live births in 2009 to 2011 (p = 0.031).ConclusionThe high CS rate among low-risk groups suggests that many CSs might have been performed on questionable indications. Such a trend may result in even higher CS rates in the future. While CS can improve perinatal outcomes, it does not necessarily do so if performed routinely in low-risk groups.

BackgroundNeonatal mortality is a global challenge, with an estimated 1.3 million intrapartum stillbirths in 2015. The majority of these were found in low resource settings with limited options to intrapartum fetal heart monitoring devices. This trial compared frequency of abnormal fetal heart rate (FHR) detection and adverse perinatal outcomes (i.e. fresh stillbirths, 24-h neonatal deaths, admission to neonatal care unit) among women intermittently assessed by Doppler or fetoscope in a rural low-resource setting.MethodsThis was an open-label randomized controlled trial conducted at Haydom Lutheran Hospital from March 2013 through August 2015. Inclusion criteria were; women in labor, singleton, cephalic presentation, normal FHR on admission (120–160 beats/minute), and cervical dilatation ≤7 cm. Verbal consent was obtained.ResultsA total of 2684 women were recruited, 1309 in the Doppler and 1375 in the fetoscope arms, respectively. Abnormal FHR was detected in 55 (4.2%) vs 42 (3.1%). (RR = 1.38; 95%CI: 0.93, 2.04) in the Doppler and fetoscope arms, respectively. Bag mask ventilation was performed in 80 (6.1%) vs 82 (6.0%). (RR = 1.03; 95%CI: 0.76, 1.38) of neonates, and adverse perinatal outcome was comparable 32(2.4%) vs 35(2.5%). (RR = 0.9; 95%CI: 0.59, 1.54), in the Doppler and fetoscope arms, respectively.ConclusionThis trial failed to demonstrate a statistically significant difference in the detection of abnormal FHR between intermittently used Doppler and fetoscope and adverse perinatal outcomes. However, FHR measurements were not performed as often as recommended by international guidelines. Conducting a randomized controlled study in rural settings with limited resources is associated with major challenges.Trial registrationThis clinical trial was registered on April 2013 with registration number NCT01869582.