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The effect of tranexamic acid on blood loss and maternal outcome in the treatment of persistent postpartum hemorrhage: A nationwide retrospective cohort study.

ABSTRACT: Recent results show a protective effect of tranexamic acid on death due to bleeding in patients with postpartum hemorrhage in low- and middle-resource countries. We quantify the association between early administration of tranexamic acid compared to late or no administration and severe acute maternal morbidity and blood loss among women suffering from persistent severe postpartum hemorrhage in a high-income country.We performed a nationwide retrospective cohort study in 61 hospitals in the Netherlands. The study population consisted of 1260 women with persistent postpartum hemorrhage who had received at least four units of red cells, or fresh frozen plasma or platelets in addition to red cells. A review of medical records was performed and cross-referenced with blood bank data. The composite endpoint comprised maternal morbidity (hysterectomy, ligation of the uterine arteries, emergency B-Lynch suture, arterial embolization or admission into an intensive care unit) and mortality.247 women received early tranexamic acid treatment. After adjustment for confounding, odds ratio for the composite endpoint for early tranexamic acid (n = 247) versus no/late tranexamic acid (n = 984) was 0.92 (95% confidence interval (CI) 0.66 to 1.27). Propensity matched analysis confirmed the absence of a difference between women with and without tranexamic acid. Blood loss after administration of first line therapy did not differ significantly between the two groups (adjusted difference -177 mL, CI -509.4 to +155.0).Our findings suggest that in a high-resource country the effect of tranexamic acid on both blood loss and the combined endpoint of maternal mortality and morbidity may be disappointing.

SUBMITTER: Gillissen A

PROVIDER: S-EPMC5673178 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The effect of tranexamic acid on blood loss and maternal outcome in the treatment of persistent postpartum hemorrhage: A nationwide retrospective cohort study.

Gillissen Ada A Henriquez Dacia D C A DDCA van den Akker Thomas T Caram-Deelder Camila C Wind Merlijn M Zwart Joost J JJ van Roosmalen Jos J Eikenboom Jeroen J Bloemenkamp Kitty W M KWM van der Bom Johanna G JG

PloS one 20171106 11

<h4>Background</h4>Recent results show a protective effect of tranexamic acid on death due to bleeding in patients with postpartum hemorrhage in low- and middle-resource countries. We quantify the association between early administration of tranexamic acid compared to late or no administration and severe acute maternal morbidity and blood loss among women suffering from persistent severe postpartum hemorrhage in a high-income country.<h4>Methods and findings</h4>We performed a nationwide retrosp ...[more]

PMID: 29107951

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Project description:BackgroundNewer research comparing routes of medication administration has extended beyond efficacy as a primary endpoint to incorporate patient preference. However, little is known about the preferences of pregnant women in terms of routes of medication administration, specifically with regards to hemorrhage prevention and control.ObjectiveThis study aimed to understand the preferences of pregnant women in terms of medical interventions to prevent hemorrhage at the time of delivery.Study designSurveys were distributed from April 2022 to September 2022 using electronic tablets at a single urban center with an annual delivery volume of 3000 women per year to women >18 years of age who were either currently pregnant or have been pregnant in the past. Subjects were asked to choose their preferred route of administration from the following options: intravenous, intramuscular, or subcutaneous. The primary outcome was patient preference on the route of medication administration during a hemorrhage event.ResultsThe study cohort included 300 patients, mostly African American (39.8%) followed by White (32.1%), and the majority of the participants ranged from 30 to 34 years of age (31.7%). When asked which method of administration they would prefer to prevent hemorrhage before birth, the results were as follows: 31.1% would prefer intravenous, 23.0% had no preference, 21.2% were unsure, 15.9% preferred subcutaneous, and 8.8% preferred intramuscular administration. In addition, 69.4% of respondents reported that they have never declined or avoided intramuscular administration of medication if recommended by their physician.ConclusionAlthough some survey participants preferred an intravenous route of administration, 68.9% of subjects were unsure, had no preference, or preferred nonintravenous routes. This information is helpful particularly in low-resource settings where intravenous treatments are not readily available or in urgent clinical situations in which intravenous administration routes are not easily obtainable in high-risk patients.

Project description:Background The Japan Society of Obstetrics and Gynecology and the Japan Association of Obstetricians and Gynecologists have issued the guidelines and recommendations on postpartum hemorrhage since 2010 and have been conducted widespread educational activities from 2012. The aim of this study was to investigate the impact of these efforts by the Societies to prevent maternal deaths due to obstetric hemorrhage on trends in epidemiology and management of severe postpartum hemorrhage in Japan. Methods A national retrospective cohort study was conducted using the national database of health insurance claims for the period 2012 and 2018. The subjects were all insured women who received a blood transfusion for postpartum hemorrhage. The primary endpoints of this study were hysterectomy and maternal mortality. The etiology of hemorrhage, treatment facility, type of procedure, and blood transfusion volume were tabulated. Results Women with postpartum hemorrhage that underwent transfusion increased from 3.5 to 5.5 per 1000 deliveries between 2012 and 2018. The most common cause of postpartum hemorrhage was atonic hemorrhage. After insurance coverage in 2013, the intrauterine balloon tamponade use increased to 20.3% of postpartum hemorrhages treated with transfusion in 2018, while the proportion of hysterectomy was decreased from 7.6% (2013–2015) to 6.4% (2016–2018) (p < 0.0001). The proportion of postpartum hemorrhage in maternal deaths decreased from 21.1% (2013–2015) to 14.1% (2016–2018) per all maternal deaths cases (p = 0.14). Cases with postpartum hemorrhage managed in large referral hospitals was increased (65.9% in 2012 to 70.4% in 2018) during the study period (p < 0.0001). Conclusions The efforts by the Societies to prevent maternal mortality due to obstetric hemorrhage resulted in a significant decrease in the frequency of hysterectomies and a downward trend in maternal mortality due to obstetric hemorrhage. Supplementary Information The online version contains supplementary material available at 10.1186/s12884-022-04824-7.

Project description:ImportanceEarly plasma transfusion for women with severe postpartum hemorrhage (PPH) is recommended to prevent coagulopathy. However, there is no comparative, quantitative evidence on the association of early plasma transfusion with maternal outcomes.ObjectiveTo compare the incidence of adverse maternal outcomes among women who received plasma during the first 60 minutes of persistent PPH vs women who did not receive plasma for similarly severe persistent PPH.Design, setting, and participantsThis multicenter cohort study used a consecutive sample of women with persistent PPH, defined as PPH refractory to first-line measures to control bleeding, between January 1, 2011, and January 1, 2013. Time-dependent propensity score matching was used to select women who received plasma during the first 60 minutes of persistent PPH and match each of them with a woman who had shown the same severity and received the same treatment of PPH but who had not received plasma at the moment of matching. Transfusions were not guided by coagulation tests. Statistical analysis was performed from June 2018 to June 2019.ExposuresTransfusion of plasma during the first 60 minutes of persistent PPH vs no or later plasma transfusion.Main outcomes and measuresIncidence of adverse maternal outcomes, defined as a composite of death, hysterectomy, or arterial embolization.ResultsThis study included 1216 women (mean [SD] age, 31.6 [5.0] years) with persistent PPH, of whom 932 (76.6%) delivered vaginally and 780 (64.1%) had PPH caused by uterine atony. Seven women (0.6%) died because of PPH, 62 women (5.1%) had a hysterectomy, and 159 women (13.1%) had arterial embolizations. Among women who received plasma during the first 60 minutes of persistent PPH, 114 women could be matched with a comparable woman who had not received plasma at the moment of matching. The incidence of adverse maternal outcomes was similar between the women, with adverse outcomes recorded in 24 women (21.2%) who received early plasma transfusion and 23 women (19.9%) who did not receive early plasma transfusion (odds ratio, 1.09; 95% CI, 0.57-2.09). Results of sensitivity analyses were comparable to the primary results.Conclusions and relevanceIn this cohort study, initiation of plasma transfusion during the first 60 minutes of persistent PPH was not associated with adverse maternal outcomes compared with no or later plasma transfusion, independent of severity of PPH.

Project description:OBJECTIVE:We aimed to better understand how well postpartum blood loss and common postpartum hemorrhage (PPH) definitions (i.e. blood loss ?500ml = PPH, ?1000ml = "severe" PPH) correlate with postpartum anemia and fall in hemoglobin. METHODS:Secondary analysis of data from three randomized trials that objectively measured postpartum blood loss and pre- and post-delivery hemoglobin among vaginal deliveries: one trial included 1056 home-births in Pakistan and two multi-country hospital-based trials included 1279 women diagnosed with PPH. We calculated Spearman's correlation coefficients (rs) for blood loss with hemoglobin drop and postpartum hemoglobin, and we compared PPH blood loss markers (?500ml, ?1000ml) with large hemoglobin drops (?2 g/dL) and the threshold for moderate postpartum anemia (<10g/dL). RESULTS:In the Pakistan study and the multi-country trials, blood loss was weakly correlated with hemoglobin drop (Pakistan: rs = -0.220, multi-country trials: rs = -0.271) and postpartum hemoglobin (Pakistan: rs = -0.220, multi-country trials: rs = -0.316). In both the Pakistan and multi-country trials, hemoglobin drop ?2 g/dL occurred in less than half of women with 500-999 ml blood loss (55/175 [31%] and 302/725 [42%], respectively) and was more common among women who bled ?1000ml (19/28 [68%] and 347/554 [63%], respectively). Similarly, in the Pakistan and multi-country trials, postpartum anemia <10 g/dL was less frequent among women who bled 500-999 ml (55/175 [31%] and 390/725 [54%], respectively) and more frequent among women with ?1000ml blood loss (20/28 [71%] and 416/554 [75%], respectively). CONCLUSIONS:Postpartum morbidity as measured by hemoglobin markers was common for women with blood loss ?1000ml and relatively infrequent among women with blood loss 500-999ml. These findings reinforce the importance of severe PPH as the preferred outcome to be used in research. The weak correlation between blood loss and hemoglobin markers also suggests that this relationship is not straightforward and should be carefully interpreted.

Project description:BackgroundPostpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, particularly in low- and middle-income countries; however, the majority of these deaths could be avoided with adequate obstetric care. Analyzing severe maternal outcomes (SMO) has been a major approach for evaluating the quality of the obstetric care provided, since the morbid events that lead to maternal death generally occur in sequence. The objective of this study was to analyze the clinical profile, management, maternal outcomes and factors associated with SMO in women who developed PPH and were admitted to an obstetric intensive care unit (ICU) in northeastern Brazil.MethodsThis retrospective cohort study included a non-probabilistic, consecutive sample of postpartum women with a diagnosis of PPH who were admitted to the obstetric ICU of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) between January 2012 and March 2020. Sociodemographic, biological and obstetric characteristics and data regarding childbirth, the management of PPH and outcomes were collected and analyzed. The frequency of maternal near miss (MNM) and death was calculated. Multiple logistic regression analysis was performed to determine the adjusted odd ratios (AOR) and their 95% confidence intervals (95% CI) for a SMO.ResultsOverall, 136 cases of SMO were identified (37.9%), with 125 cases of MNM (34.9%) and 11 cases of maternal death (3.0%). The factors that remained associated with an SMO following multivariate analysis were gestational age ≤ 34 weeks (AOR = 2.01; 95% CI: 1.12-3.64; p < 0.02), multiparity (AOR = 2.20; 95% CI: 1.10-4.68; p = 0.02) and not having delivered in the institute (AOR = 2.22; 955 CI: 1.02-4.81; p = 0.04).ConclusionWomen admitted to the obstetric ICU with a diagnosis of PPH who had had two or more previous deliveries, gestational age ≤ 34 weeks and who had delivered elsewhere were more likely to have a SMO.

Project description:BackgroundGrowing evidence supports improved survival with prehospital blood products. Recent trials show a benefit of prehospital tranexamic acid (TXA) administration in select subgroups. Our objective was to determine if receiving prehospital packed red blood cells (pRBC) in addition to TXA improved survival in injured patients at risk of hemorrhage.MethodsWe performed a secondary analysis of all scene patients from the Study of Tranexamic Acid during Air and ground Medical Prehospital transport trial. Patients were randomized to prehospital TXA or placebo. Some participating EMS services utilized pRBC. Four resuscitation groups resulted: TXA, pRBC, pRBC+TXA, and neither. Our primary outcome was 30-day mortality and secondary outcome was 24-hour mortality. Cox regression tested the association between resuscitation group and mortality while adjusting for confounders.ResultsA total of 763 patients were included. Patients receiving prehospital blood had higher Injury Severity Scores in the pRBC (22 [10, 34]) and pRBC+TXA (22 [17, 36]) groups than the TXA (12 [5, 21]) and neither (10 [4, 20]) groups (p < 0.01). Mortality at 30 days was greatest in the pRBC+TXA and pRBC groups at 18.2% and 28.6% compared with the TXA only and neither groups at 6.6% and 7.4%, respectively. Resuscitation with pRBC+TXA was associated with a 35% reduction in relative hazards of 30-day mortality compared with neither (hazard ratio, 0.65; 95% confidence interval, 0.45-0.94; p = 0.02). No survival benefit was observed in 24-hour mortality for pRBC+TXA, but pRBC alone was associated with a 61% reduction in relative hazards of 24-hour mortality compared with neither (hazard ratio, 0.39; 95% confidence interval, 0.17-0.88; p = 0.02).ConclusionFor injured patients at risk of hemorrhage, prehospital pRBC+TXA is associated with reduced 30-day mortality. Use of pRBC transfusion alone was associated with a reduction in early mortality. Potential synergy appeared only in longer-term mortality and further work to investigate mechanisms of this therapeutic benefit is needed to optimize the prehospital resuscitation of trauma patients.Level of evidenceTherapeutic/Care Management; Level III.

Dataset Information

The effect of tranexamic acid on blood loss and maternal outcome in the treatment of persistent postpartum hemorrhage: A nationwide retrospective cohort study.

Publications

The effect of tranexamic acid on blood loss and maternal outcome in the treatment of persistent postpartum hemorrhage: A nationwide retrospective cohort study.

Similar Datasets

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