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 ...
Background Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0•9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0•9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.
Background: Gestational diabetes mellitus (GDM) is a major public health problem and threat to maternal and child health in Africa. No prior review has been conducted in Africa using the updated GDM diagnostic criteria. Therefore, this review aimed to estimate the pooled prevalence and determinants of GDM in Africa by using current international diagnostic criteria. Methods: A systematic review and meta-analysis was conducted by comprehensive search of the published studies in Africa. Electronic databases (PubMed, Scopus, Cochrane Library, EMBASE, Google Scholar, CINAHL, Web of Science, Science direct and African Journals Online) were searched using relevant search terms. Data were extracted on an excel sheet and Stata/ SE 14.0 software was used to perform the meta-analysis. Heterogeneity of included studies were assessed using I 2 and Q test statistics. I 2 > 50% and Q test with its respective p-value < 0.05 were suggestive for the presence of a significant heterogeneity. Publication bias was assessed using the Egger's regression test and funnel plot. Subgroup and sensitivity analyses were done. A random effects model was used to estimate the pooled prevalence of GDM and odds ratio (OR) with 95% confidence interval (CI). Result: A total of 23 studies were included in the final analysis. The pooled prevalence of GDM in Africa was 13.61% (95% CI: 10.99, 16.23; I 2 = 96.1%), and 14.28% (95% CI, 11.39, 17.16; I 2 = 96.4%) in the sub-Saharan African region. The prevalence was highest in Central Africa 20.4% (95% CI, 1.55, 38.54), and lowest in Northern Africa 7.57% (95% CI, 5.89, 9.25) sub-regions. Overweight and obesity, macrosomia, family history of diabetes, history of stillbirth, history of abortion, chronic hypertension and history of previous GDM had positively associated with GDM. Conclusions: The prevalence of GDM is high in Africa. Being overweighed and/or obese, ever had macrocosmic baby, family history of diabetes, history of stillbirth, history of abortion or miscarriage, chronic hypertension and history of previous GDM were factors associated with GDM. Preventing overweighed and obese, giving due attention to women having high-risk cases for GDM in pregnancy are strongly recommended to mitigate the burden. Systematic review registration: PROSPERO (2018:CRD42018116843).
Background Globally, Gestational Diabetes Mellitus (GDM) is rising, but it is a neglected health threat to mothers and their children in low resource countries. Although, GDM is known in Ethiopia, information regarding it remains scarce by recent diagnostic criteria. Therefore, this study aimed to determine the prevalence of GDM and associated factors among women attending antenatal care at Gondar town public health facilities, Northwest Ethiopia. Methods A cross-sectional study was conducted among 1027 pregnant women selected by the systematic random sampling technique. The universal one-step screening and diagnostic strategy was done using a two-hour 75 g oral glucose tolerance test. GDM was diagnosed using updated diagnostic criteria (2017 American Diabetes Association (ADA) or 2013 World Health Organization (WHO) or modified International Association of the Diabetes and Pregnancy Study Groups diagnostic criteria (IADPSG)). Binary logistic regression model was used to identify factors associated with GDM. Results Of the total 1027 pregnant women, 12.8% (95% CI: 10.8–14.8) were diagnosed with GDM. Overweight and/or obesity (MUAC ≥28 cm) (AOR = 2.25, 95% CI: 1.18–4.26), previous history of GDM (AOR = 5.82, 95% CI: 2.57–13.18), family history of diabetes (AOR = 4.03, 95% CI: 1.57–10.35), low physical activity (AOR = 3.36, 95% CI: 1.60–7.04), inadequate dietary diversity (AOR = 1.9, 95% CI: 1.02–3.53), and antenatal depression (AOR = 4.12, 95% CI: 1.85–9.20) were significantly associated with GDM. Conclusions The prevalence of GDM among women attending antenatal care at Gondar town public health facilities was high. Previous history of GDM, antenatal depression, family history of diabetes, low physical activity, overweight and/or obesity and inadequate dietary diversity were significantly associated with GDM. Routine screening of pregnant women and healthy lifestyle are strongly recommended.
Background: Gestational diabetes mellitus is a leading medical condition woman encounter during pregnancy with serious short-and long-term consequences for maternal morbidity. However, limited evidence was available on potential impacts of gestational diabetes mellitus using updated international diagnostic criteria on adverse maternal outcomes. Therefore, this study aimed to assess the effects of gestational diabetes mellitus on the risk of adverse maternal outcomes in Northwest Ethiopia. Methods: A prospective cohort study was conducted among pregnant women followed from pregnancy to delivery. Gestational diabetes mellitus status was determined by using a two-hour 75 g oral glucose tolerance test and based on updated international diagnostic criteria. Multivariable log-binomial model was used to examine the effects of gestational diabetes mellitus on the risk of adverse maternal outcomes. Results: A total of 694 women completed the follow-up and included in the analysis. Women with gestational diabetes mellitus had a higher risk of composite adverse maternal outcome (ARR=1.58, 95% CI: 1.22, 2.04), caesarean delivery (ARR=1.67; 95%: 1.15, 2.44), pregnancy induced hypertension (ARR= 3.32; 95%: 1.55, 7.11), premature rupture of membranes (ARR= 1.83; 95%: 1.02, 3.27), antepartum hemorrhage (ARR= 2.10; 95%: 1.11, 3.98) and postpartum hemorrhage (ARR= 4.85; 95%:2.28, 10.30) compared to women without gestational diabetes mellitus. Conclusions: Gestational diabetes mellitus increased the risk of adverse maternal outcomes. This implies that maternal care and intervention strategies relating to women with gestational diabetes mellitus should be strengthened.
Pain relief, for different reasons, is controversial worldwide. We designed this study to assess the level of awareness of antenatal patients to analgesia in labour and to evaluate the effect of age, parity and educational status on the awareness and acceptability of pain relief in labour. A structured questionnaire was administered to 1,000 antenatal patients between 1 June 2000 and 31 May 2001. Spearman's correlation coefficient was applied to estimate the correlation between the ranked dependent variable (awareness and acceptability) and age, parity and educational status (independent variables). Awareness of pain relief methods was seen in only 27.1%. The most common method known was the use of systemic opioids (80%); only 10% were aware of epidural analgesia and about 14% knew of inhalational analgesia. Acceptance of methods was, however, 57.6%. The most common reason for non-acceptance was that 'The pain of labour is natural' in 76.5%, 12% feared complications to the baby and 25% gave other reasons. Age, parity and educational status did not affect awareness. Educational status had positive correlation (rho = 0.13, P < 0.05) with acceptance while age had a negative correlation (rho = -0.124, P<0.05). Awareness of obstetric analgesia is still relatively low in this environment; however, a high proportion of patients would accept analgesia in labour if offered.
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