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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.

BackgroundIntrapartum Fetal Heart Rate (FHR) monitoring is crucial for the early detection of abnormal FHR, facilitating timely obstetric interventions and thus the potential reduction of adverse perinatal outcomes. We explored midwifery practices of intrapartum FHR monitoring pre and post implementation of a novel continuous automatic Doppler device (the Moyo).MethodologyA pre/post observational study among low-risk pregnancies at a tertiary hospital was conducted from March to December 2016. In the pre-implementation period, intermittent monitoring was conducted with a Pinard stethoscope (March to June 2016, n = 1640 women). In the post-implementation period, Moyo was used for continuous FHR monitoring (July-December 2016, n = 2442 women). The primary outcome was detection of abnormal FHR defined as absent, FHR<120or FHR>160bpm. The secondary outcomes were rates of assessment/documentation of FHR, obstetric time intervals and intrauterine resuscitations. Chi-square test, Fishers exact test, t-test and Mann-Whitney U test were used in bivariate analysis whereas binary and multinomial logistic regression were used for multivariate.ResultsMoyo use was associated with greater detection of abnormal FHR (8.0%) compared with Pinard (1.6%) (p<0.001). There were higher rates of non-assessment/documentation of FHR pre- (45.7%) compared to post-implementation (2.2%) (p<0.001). At pre-implementation, 8% of deliveries had FHR documented as often as ≤ 60 minutes, compared to 51% post-implementation (p<0.001). Implementation of continuous FHR monitoring was associated with a shorter time interval from the last FHR assessment to delivery i.e. median (IQR) of 60 (30,100) to 45 (21,85) minutes (p<0.001); and shorter time interval between each FHR assessment i.e. from 150 (86,299) minutes to 60 (41,86) minutes (p<0.001). Caesarean section rates increased from 2.6 to 5.4%, and vacuum deliveries from 2.2 to 5.8% (both p<0.001). Perinatal outcomes i.e. fresh stillbirths and early neonatal deaths were similar between time periods. The study was limited by both lack of randomization and involvement of low-risk pregnant women with fewer adverse perinatal outcomes than would be expected in a high-risk population.ConclusionImplementation of the Moyo device, which continuously measures FHR, was associated with improved quality in FHR monitoring practices and the detection of abnormal FHR. These improvements led to more frequent and timely obstetric responses. Follow-up studies in a high-risk population focused on a more targeted description of the FHR abnormalities and the impact of intrauterine resuscitation is a critical next step in determining the effect on reducing perinatal mortality.

Continuous FHR monitoring increased identification of abnormal FHR and subsequent intrauterine resuscitations. ClinicalTrials.gov: NCT02790814.

In low-resource settings, FSB may be prevented by using a combined strategy of clinical risk identification, early detection of abnormal FHR, and expedited delivery.

We conducted a retrospective analysis of perinatal mortality at Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania 1999-2003 in order to categorise/classify perinatal deaths as well as to identify key factors in perinatal care that could be improved. Data were retrieved from the MNH obstetric database and causes of early neonatal deaths were traced from the neonatal ward register. The study includes all foetuses weighing =500g. A modified Nordic-Baltic classification was used for classification of perinatal deaths. Over a 5-year period there were 77,815 babies born with a perinatal mortality rate of 124 per 1000 births, 78% of which was labour related stillbirth. The PMR was 913/1000 for singleton births and 723/1000 for multiple births for babies weighing less than 1500 grams and 65/1000 for singleton births and 116/1000 for multiple births for babies weighing 2500 grams or more. Babies weighing less than 1500 grams contributed 26% of PMR, whereas 41% occurred in babies weighing 2500 grams or more. The majority (79%) of neonatal deaths had Apgar score <7 at 5 minutes and the most common causes of neonatal mortality were birth asphyxia (37%) and prematurity (29%). Labour related deaths were more common in multiple pregnancies. The majority of the perinatal deaths should be essentially avoidable through improved quality of intrapartum care. Establishment of perinatal audit at MNH can help identify key actions for improved care.