Antifibrinolytic drugs for treating primary postpartum haemorrhage.
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ABSTRACT:
SUBMITTER: Shakur H
PROVIDER: S-EPMC6491317 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: Not available
| S-EPMC8407481 | biostudies-literature
Project description:BACKGROUND: Postpartum haemorrhage remains an important cause of maternal death despite treatment with conventional therapy. Uncontrolled studies and one randomised comparison with conventional oxytocics have reported dramatic effects with high-dose misoprostol, usually given rectally, for treatment of postpartum haemorrhage, but this has not been evaluated in a placebo-controlled trial. METHODS: The study was conducted at East London Hospital Complex, Tembisa and Chris Hani Baragwanath Hospitals, South Africa. Routine active management of the third stage of labour was practised. Women with more than usual postpartum bleeding thought to be related to inadequate uterine contraction were invited to participate, and to sign informed consent. All routine treatment was given from a special 'Postpartum Haemorrhage Trolley'. In addition, participants who consented were enrolled by drawing the next in a series of randomised treatment packs containing either misoprostol 5 x 200 microg or similar placebo, which were given 1 orally, 2 sublingually and 2 rectally. RESULTS: With misoprostol there was a trend to reduced blood loss >/=500 ml in 1 hour after enrolment measured in a flat plastic 'fracture bedpan', the primary outcome (6/117 vs 11/120, relative risk 0.56; 95% confidence interval 0.21 to 1.46). There was no difference in mean blood loss or haemoglobin level on day 1 after birth < 6 g/dl or blood transfusion. Side-effects were increased, namely shivering (63/116 vs 30/118; 2.14, 1.50 to 3.04) and pyrexia > 38.5 degrees C (11/114 vs 2/118; 5.69, 1.29 to 25). In the misoprostol group 3 women underwent hysterectomy of whom 1 died, and there were 2 further maternal deaths. CONCLUSIONS: Because of a lower than expected incidence of the primary outcome in the placebo group, the study was underpowered. We could not confirm the dramatic effect of misoprostol reported in several unblinded studies, but the results do not exclude a clinically important effect. Larger studies are needed to assess substantive outcomes and risks before misoprostol enters routine use.
| S-EPMC514549 | biostudies-literature
Project description:BACKGROUND: Each year, worldwide about 530,000 women die from causes related to pregnancy and childbirth. Of the deaths 99% are in low and middle income countries. Obstetric haemorrhage is the leading cause of maternal mortality, most occurring in the postpartum period. Systemic antifibrinolytic agents are widely used in surgery to prevent clot breakdown (fibrinolysis) in order to reduce surgical blood loss. At present there is little reliable evidence from randomised trials on the effectiveness of tranexamic acid in the treatment of postpartum haemorrhage. METHODS: The Trial aims to determine the effect of early administration of tranexamic acid on mortality, hysterectomy and other morbidities (surgical interventions, blood transfusion, risk of non-fatal vascular events) in women with clinically diagnosed postpartum haemorrhage. The use of health services and safety, especially thromboembolic effect, on breastfed babies will also be assessed. The trial will be a large, pragmatic, randomised, double blind, placebo controlled trial among 15,000 women with a clinical diagnosis of postpartum haemorrhage. All legally adult women with clinically diagnosed postpartum haemorrhage following vaginal delivery of a baby or caesarean section will potentially be eligible. The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage. Treatment will entail a dose of tranexamic acid (1 gram by intravenous injection) or placebo (sodium chloride 0.9%) will be given as soon as possible after randomisation. A second dose may be given if after 30 minutes bleeding continues, or if it stops and restarts within 24 hours after the first dose. The main analyses will be on an 'intention to treat' basis, irrespective of whether the allocated treatment was received or not. Subgroup analyses for the primary outcome will be based on type of delivery; administration or not of prophylactic uterotonics; and on whether the clinical decision to consider trial entry was based primarily on estimated blood loss alone or on haemodynamic instability. A study with 15,000 women will have over 90% power to detect a 25% reduction from 4% to 3% in the primary endpoint of mortality or hysterectomy.
| S-EPMC2864262 | biostudies-literature
Project description:In Gabon, the proportion of maternal deaths directly related to Primary PostPartum Haemorrhage (PPPH) is 15 to 25%, despite the different means that the World Health Organization has made available to the providers of Emergency Obstetrical and Neonatal Care (EmONC). The objective of this study was to determine the prevalence and epidemiological characteristics of Primary PostPartum Haemorrhage to improve its management and reduce the rate of maternal deaths. An analytical retrospective study involved 42,728 records, whose data were collected using a chart collection form on the basis of information contained in partograms and other patient records. Sociodemographic variables were expressed using percentage. The relationship between the etiologies of PPPH and certain characteristics of the women was established using the ORs with their 95% confidence intervals. The difference was significant if p < 0.05. The prevalence of PPPH was 1.6%. Delivery haemorrhages accounted for 65.5% of PPPH. The main factors associated with delivery haemorrhages were pauci parity and multiparity (p = 0.003 and 0.051), post-term (p = 0.042), and birth weight >4,000 g (p = 0.006). Those associated with genital tract injuries were young maternal age (p = 0.008) and multiparity (p = 0.028). The most common etiology was haemorrhage from delivery. Multiparity remains the most common risk factor and the young age of the patients. It is important to improve management through better assessment of blood loss in the primary postpartum period as well as capacity building of health providers on EmONC.
| S-EPMC8452036 | biostudies-literature
Project description:ObjectivesTo explore the association between postpartum haemorrhage (PPH) and postpartum depression (PPD), taking into account the role of postpartum anaemia, delivery experience and psychiatric history.MethodsA nested cohort study (n = 446), based on two population-based cohorts in Uppsala, Sweden. Exposed individuals were defined as having a bleeding of ?1000 ml (n = 196) at delivery, and non-exposed individuals as having bleeding of <650 ml (n = 250). Logistic regression models with PPD symptoms (Edinburgh Postnatal Depression scale (EPDS) score ? 12) as the outcome variable and PPH, anaemia, experience of delivery, mood during pregnancy and other confounders as exposure variables were undertaken. Path analysis using Structural Equation Modeling was also conducted.ResultsThere was no association between PPH and PPD symptoms. A positive association was shown between anaemia at discharge from the maternity ward and the development of PPD symptoms, even after controlling for plausible confounders (OR = 2.29, 95%CI = 1.15-4.58). Path analysis revealed significant roles for anaemia at discharge, negative self-reported delivery experience, depressed mood during pregnancy and postpartum stressors in increasing the risk for PPD.ConclusionThis study proposes important roles for postpartum anaemia, negative experience of delivery and mood during pregnancy in explaining the development of depressive symptoms after PPH.
| S-EPMC4726585 | biostudies-literature
Project description:BackgroundTo determine the prevalence, related factors and maternal outcomes of primary PPH in governmental hospitals in Kabul Afghanistan.MethodsAn observational study was designed to determine the prevalence, related factors and maternal outcomes of primary PPH in governmental hospitals in Kabul-Afghanistan. The population of this study consisted of all women who gave birth to a child between August and October 2018. The structured checklist was used to collect the data from patients who were suffering from primary PPH.ResultsAmong the 8652 women who were observed, 215 (2.5%) of them suffered from primary PPH and 2 (0.9%) of them died under caesarean section. The most common related factors of primary PPH were uterine atonia (65.6%), previous PPH (34.9%), prolonged labor (27%), genital tract trauma (26.5%), and induction of labor (20.5%). The most common maternal outcomes of primary PPH were respiratory failure (7%), hysterectomy (6%), and hypovolaemic shock (5.1%).ConclusionsAccording to our findings, the major cause of postpartum bleeding was uterine atonia. Therefore, postpartum care of women is essential, especially for those with previous PPH and prolonged labor that require more attention.
| S-EPMC7390104 | biostudies-literature
Project description:ObjectiveTo assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.DesignA cluster-randomised non-inferiority community trial.SettingHealth sub-centres and home deliveries in the Bijapur district of Karnataka, India.PopulationWomen with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.MethodsAuxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main outcome measuresPostpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.ResultsMisoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).ConclusionSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable abstractSecondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.
| S-EPMC5014137 | biostudies-literature
Project description:The aim of our study was to assess the theoretical and practical knowledge of French obstetricians about the surgical management of postpartum haemorrhage (PPH). Our study is a national anonymous self-administered survey. A total of 363 obstetricians responded to this questionnaire between December 2013 and April 2014. Questionnaire sent through email to all French obstetricians who are members of either of two federations of hospital-based obstetricians. Answers were collected until the end of June 2014. The main outcome measure was obstetricians' level of mastery of each surgical technique. The results were analysed descriptively (proportions). Only the 286 questionnaires fully completed were analysed; the complete response rate was 23% (286/1246). In all, 33% (95/286) of the responding obstetricians reported that they had not mastered sufficiently or even at all the technique for bilateral ligation of the uterine arteries, 37% (105/286) for uterine compression suture, 62% (178/286) for ligation of the internal iliac arteries, and 47% (134/286) for emergency peripartum hysterectomy. In all, 18% (52/286) of respondents stated that they had not mastered any of these techniques. Our study shows that a worrisome number of French obstetricians reported insufficient mastery of the surgical techniques for PPH management.
| S-EPMC4962082 | biostudies-other
Project description:BACKGROUND:There is empirical evidence that measured postpartum blood loss has a lognormal distribution. This feature can be used to analyze events of the type 'blood loss greater than a certain cutoff point' using a lognormal approach, which takes into account all the quantitative observations, as opposed to dichotomizing the variable blood loss volume into two categories. This lognormal approach uses all the information contained in the data and is expected to provide more efficient estimates of proportions and relative risk when comparing treatments to prevent postpartum haemorrhage. As a consequence, sample size can be reduced in clinical trials, while keeping the statistical precision requirements. METHODS:The authors illustrate how a lognormal approach can be used in this situation, using data from a clinical trial and the event 'blood loss greater than 1000 mL'. RESULTS:Estimates of the proportions of this event for each treatment, and relative risks obtained with this method are presented and compared with the standard estimates obtained by dichotomizing measured blood loss volume. An example of how the blood loss distributions of two treatments can be compared is also presented. Different scenarios of the sample size needed to compare two treatments or interventions are presented to illustrate how with the lognormal approach the size of a clinical trial can be reduced. CONCLUSIONS:A distributional approach for postpartum blood loss using the lognormal distribution fitted to the data results in more precise estimates of risks of events and relative risks, compared to the use of binomial proportions of events. It also results in reduced required sample size for clinical trials. TRIAL REGISTRATION:This paper reports a secondary analysis for a trial that was registered at clinicaltrials.gov ( NCT00781066 ).
| S-EPMC6020008 | biostudies-literature
Project description:OBJECTIVE: Maternal mortality ratio due to postpartum haemorrhage (PPH) is higher in France than in Canada. We explored this difference by comparing PPH features between these two countries. METHODS: Using data between 2004 and 2006, we compared the incidence, risk factors, causes and use of second-line treatments, of PPH between France (N?=?6,660 PPH) and Canada (N?=?9,838 PPH). We assessed factors associated with PPH through multivariate logistic models. RESULTS: PPH incidence, overall (4.8% (95% CI 4.7-4.9) in Canada and 4.5% (95% CI 4.4-4.7) in France), and after vaginal delivery (5.3% (95%CI 5.2-5.4) in Canada and 4.8 (95%CI 4.7-4.9) in France), were significantly higher in Canada than in France, but not after caesarean delivery. Women delivering without PPH were similar between the two populations, except for macrosomia (11% in Canada, 7% in France, p<0.001), caesarean delivery (27% in Canada, 18% in France, p<0.001), and episiotomy (17% in Canada, 34% in France, p<0.001). After vaginal delivery, factors strongly associated with PPH were multiple pregnancy, operative delivery and macrosomia in both populations, and episiotomy only in France (Odds Ratio 1.39 (95% CI 1.23-1.57)). The use of second-line treatments for PPH management was significantly more frequent in France than in Canada after both vaginal and caesarean delivery. CONCLUSION: PPH incidence was not higher in France than in Canada and there was no substantial difference in PPH risk factors between the 2 countries. Greater use of second-line treatments in PPH management in France suggests a more frequent failure of first-line treatments and a higher rate of severe PPH, which may be involved in the higher maternal mortality ratio due to PPH.
| S-EPMC3691240 | biostudies-other