Conseguenze economiche dell’introduzione del dispositivo JADA® come trattamento alternativo per la gestione dell’emorragia postpartum in Italia

A Retrospective Cohort Study Evaluating the Safety and Efficacy of Peri-Partum Tranexamic Acid for Women with Inherited Bleeding Disorders

Prophylactic strategies for prevention of postpartum haemorrhage in caesarean delivery: a systematic review and Bayesian network meta-analysis of randomised controlled trials.

Aim. To evaluate the efficacy and safety of uterine balloon tamponade for the management of postpartum haemorrhage.Materials and Methods. We have screened the Cochrane Library and PubMed for the following keywords: “intrauterine balloon tamponade”, “controlled balloon tamponade”, “controlled balloon tamponade” AND “postpartum bleeding/haemorrhage” during 5 years (2018-2023). In total, we have identified 358 publications including 3 meta-analyses, 6 systematic reviews, and 13 randomized controlled trials. After checking titles and abstracts to remove duplicates, we selected 38 sources which met the selection criteria.Results. Postpartum haemorrhage remains the leading cause of maternal mortality in both developing and developed countries. In most cases, postpartum haemorrhage occurs due to atony and is controlled by administration of uterotonics. However, if uncurbed, postpartum haemorrhage requires blood transfusion and surgery. Currently, uterine balloon tamponade is considered as one of the most efficient and safe technologies for controlling postpartum haemorrhage and preventing hysterectomy, yet a number of studies have reported negative results. Several investigations showed an advantage of double-balloon tamponade as it provides an additional benefit of vascular compression of the lower uterine segment. Generally, uterine balloon tamponade is an efficient intervention which allows to avoid additional surgeries (uterine artery embolization or hysterectomy) in 87.3 – 100.0% of cases with a relatively low complication rate (< 6.7% – 9.4%).Conclusion. The effectiveness of uterine balloon tamponade and the risk of complications are probably determined by the type of device, the learning curve effect, and the regularity and quality of training of medical personnel. Further in-depth multicenter studies in this direction are required.

New and Off-Label Uses of Tranexamic Acid.

BackgroundPostpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended.Methods and designA multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %.DiscussionIn addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH.Trial registrationClinicalTrials.gov NCT02302456 (November 17, 2014)

Haemorrhage is the leading cause of maternal mortality, accounting for about 35% of all maternal deaths. About 14 million women around the world suffer from Post Partum Hemorrhage (PPH) every year. Of them, about 2% die with an average interval of 2-4 hrs from onset of bleeding. Tranexamic Acid (TXA) is the most effective of the available anti-fibrinolytics, which has been shown to be very useful in reducing blood loss and incidence of blood transfusion in different surgeries. The study was done to see the efficacy of injectable tranexamic acid in addition to conventional treatment in control of atonic PPH. In this study, women having atonic PPH following vaginal delivery were grouped into two, A & B. Group A received 2 amp inj.TXA (Tranexamic acid) i.v immediately after diagnosis of PPH and Group B received 10ml distilled water i.v. Both groups received all other necessary measures for control of PPH and outcomes were recorded in a preformed data collection sheet. All data were analyzed by computer based software Statistical Packages for Social Science (SPSS) version 15.The results showed that tranexamic acid significantly reduced the volume of blood loss in atonic PPH, 1141.23±489.91 ml in study group versus 1365.25±428.22 ml in control group.PPH control within 2 hr with medical therapies occurred more in TXA group (88.09%) than in control group (57.14%). Invasive procedures were less required in TXA group than in control group ,condom catheter in 4 pt. (9.52%) compared to 11(26.19%) in control group. Hysterectomy was done in 1 case of TXA group compared to 7 cases of control group. TXA also significantly reduced the necessity of blood transfusion in PPH, 26.19% in TXA group compared to 54.76% in control group. So one gm i.v. tranexamic acid given along with other conventional measures at the diagnosis of atonic PPH significantly reduces the amount of blood loss, requirement of blood transfusion, necessity of invasive procedures. JCMCTA 2015 ; 26 (2) : 34 - 39

Postpartum hemorrhage (PPH) is a major cause of maternal mortality, with almost 300,000 cases and ~72,000 PPH deaths annually in sub-Saharan Africa. Novel prevention methods practical in community settings are required. Tranexamic acid, a drug to reduce bleeding during surgical cases including postpartum bleeding, is potentially suitable for community settings. Thus, we sought to determine the impact of tranexamic acid on PPH-related maternal mortality in sub-Saharan Africa. We created a mathematical model to determine the impact of interventions on PPH-related maternal mortality. The model was populated with baseline birth rates and mortality estimates based on a review of current interventions for PPH in sub-Saharan Africa. Based on a systematic review of literature on tranexamic acid, we assumed 30% efficacy of tranexamic acid to reduce PPH; the model assessed prophylactic and treatment tranexamic acid use, for deliveries at homes, clinics, and hospitals. With tranexamic acid only in the hospitals, less than 2% of the PPH mortality would be reduced. However, if tranexamic acid were available in the home and clinic settings for PPH prophylaxis and treatment, a nearly 30% reduction (nearly 22,000 deaths per year) in PPH mortality is possible. These analyses point to the importance of preventive and treatment interventions compatible with home and clinic use, especially for sub-Saharan Africa, where the majority of births occur at home or community health clinics. Given its feasibility to be given in the home, tranexamic acid has potential to save many lives.

WOMAN: reducing maternal deaths with tranexamic acid

Background: Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality and morbidity globally, accounting for nearly one-quarter of maternal deaths, especially in low-resource settings. Defined as blood loss of more than 500 mL following vaginal delivery or more than 1000 mL after cesarean section, PPH can rapidly become life-threatening if not promptly identified and managed. Despite advancements in obstetric care, inconsistent adherence to standardized guidelines and lack of preparedness continue to contribute to preventable maternal deaths. This review aims to synthesize the most current evidence-based guidelines for the prevention and management of PPH and assess their applicability in a tertiary care center. Materials and Methods: A Observational Study conducted with the aim of synthesizing the latest evidence-based guidelines and literature on the prevention and management of postpartum hemorrhage (PPH). The review was carried out in the Department of Obstetrics and Gynaecology, Netaji Subhas Medical College and Hospital, Amhara, Bihta, Patna, Bihar, India, from April 2024 to December 2024 . The focus was to analyze existing recommendations, compare international protocols, and assess their relevance and application in the context of clinical practice within a tertiary care center Results: Current evidence supports the routine use of AMTSL as a key strategy to prevent primary PPH, with oxytocin (10 IU IM/IV) identified as the first-line uterotonic agent. Alternatives such as misoprostol, ergometrine, and carbetocin have specific indications based on availability and patient profile. Tranexamic acid is now recommended as an early adjunct in cases of established PPH. Non-surgical methods such as uterine massage, bimanual compression, and intrauterine balloon tamponade play crucial roles in the early management of atonic PPH. In refractory cases, uterine artery ligation, compression sutures, or hysterectomy may be required. Protocolbased care and rapid response teams significantly reduce maternal complications. Simulation-based training and availability of PPH kits are increasingly recognized as best practices. Conclusion: Evidence-based prevention and management of PPH require timely intervention, judicious use of uterotonics, and structured institutional protocols. Adopting global guidelines within the framework of local resources and infrastructure can improve maternal outcomes. Regular training of healthcare workers, early identification of risk factors, and adherence to AMTSL and response algorithms are crucial to reducing the burden of PPH-related maternal morbidity and mortality.

Incidence, treatment and outcomes of postpartum haemorrhage among women admitted at a large regional referral hospital in Eastern Uganda: a one-year prospective observational study.

ObjectiveThere are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international...

Globally, postpartum hemorrhage (PPH) remains the most common direct cause of maternal mortality. This study evaluated the feasibility and acceptability of introducing heat-stable carbetocin (HSC) for PPH prevention and tranexamic acid (TXA) for PPH treatment in five Sub-Saharan African countries following recent World Health Organization (WHO) recommendations. This study also assessed healthcare providers' (HCPs') favorability toward using these medicines. We conducted a mixed methods pilot implementation study in selected facilities across Burkina Faso, Ethiopia, Ghana, Sierra Leone, and Uganda between May and December 2022. We compared baseline data obtained from patient registers with data collected during implementation on the safe and appropriate use of HSC and TXA using descriptive statistics. HCP responses were analyzed qualitatively using a thematic analysis. Following training, HSC was administered prophylactically in 11,329 (92.4%) of 12,262 deliveries in all study facilities which received a uteorotonic for PPH prevention during implementation and was used safely and appropriately. TXA administration for PPH treatment was done safely, appropriately, and within the WHO-recommended time. No adverse events were reported throughout the study. HCPs overall showed high confidence in, and favorability toward, using both medicines. Our study demonstrated that HSC and TXA can be safely and appropriately implemented in primary and tertiary facilities, and their introduction is feasible and acceptable from the perspective of HCPs. A holistic approach to training and regular supportive supervision is needed to ensure the continued safe use of these new and lesser-utilized PPH medicines. Dedicated training is required to improve the documentation of patient charts on PPH care. Introducing these medicines holds promise for improving PPH care in low- and middle-income countries, including by addressing suboptimal efficacy due to cold chain system challenges.

Introduction: Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity worldwide. Tranexamic acid (TXA) has been shown to be efficacious and safe in reducing mortality and morbidity if given within 3 hours of bleeding onset. Delayed PPH of more than 24 hours after delivery is a rare but high-risk ED presentation that requires timely management with TXA. This study aims to evaluate the patterns of TXA administration to treat delayed PPH in the ED using a retrospective review of medical reviews from 4 centres across a major urban Canadian city. Methods: We conducted a retrospective medical record review of patients presenting with PPH to 4 large urban EDs from 2013 to 2017; from 1.5 million ED visits, using a search for ICD-10 diagnostic codes of interest. Of these, the study cohort included only patients that were admitted to the hospital. Univariate analyses using Chi-squared tests and t-tests for non-continuous and continuous variables, respectively, were used to determine patient demographics and clinical characteristics significantly associated with TXA administration. Results: A total of 238 patients were included in the study cohort. Of these patients, 72.7% presented to the ED with mild hypovolemic shock, defined by a shock index score greater than 0.6. A total of 12.6% (95% CI 0.09-0.17) of patients were given TXA for PPH management in the ED. 67% (95% CI 0.47-0.82) of patients received the TXA within 3 hours of triage, whereas 33% (95% CI 0.18-0.53) received it after 3 hours, with the total mean time at 3.43 hours. 4.2% of patients required a blood transfusion and 2.9% required surgery. Univariate analyses indicated that greater maternal age (p = 0.028), lower hemoglobin levels (p = 0.014), higher shock index scores (p = 0.001), greater heart rate (p = < 0.001)), and use of oxytocin (p = <0.001) or blood products (p = < 0.001) in the ED were all significantly associated with TXA administration. Conclusion: The results from this study demonstrate that only 13% of delayed PPH patients presenting to the ED received TXA, and among those treated, 66% received TXA within 3 hours of presentation. The use of TXA was correlated with variables associated with an increased risk of morbidity. Given the rarity of delayed PPH presentation to the ED, the development of a treatment algorithm is recommended to ensure higher levels of timely TXA administration.

BackgroundPostpartum haemorrhage (PPH) remains a leading cause of maternal mortality. Many trials assessing interventions to prevent PPH base their data on low risk women. It is important to consider the impact data collection methods may have on these results. This review aims to assess trials of PPH prophylaxis by grading trials according to the degree of risk status of the population enrolled in these trials and identify differences in the PPH rates of low risk and high risk populations.MethodsSystematic review and meta-analysis using a random-effects model. Trials were identified through CENTRAL. Trials were assessed for eligibility then graded according to antenatal risk factors and method of birth into five grades. The main outcomes were overall trial rate of minor PPH (blood loss ≥500 ml) and major PPH (> 1000 ml) and method of determining blood loss (estimated/measured).ResultsThere was no relationship between minor or major PPH rate and risk grade (Kruskal-Wallis: minor - T = 0.92, p = 0.82; major - T = 0.91, p = 0.92). There was no difference in minor or major PPH rates when comparing estimation or measurement methods (Mann-Whitney: minor - U = 67, p = 0.75; major - U = 35, p = 0.72). There was however a correlation between % operative births and minor PPH rate, but not major PPH (Spearman r = 0.32 v. Spearman r = 0.098).ConclusionsUsing data from trials using low risk women to generalise best practice guidelines might not be appropriate for all births, particularly complex births. Although complex births contribute disproportionately to PPH rates, this review showed they are often underrepresented in trials. Despite this, there was no difference in reported PPH rates between studies conducted in high and low risk groups. Method of birth was shown to be an important risk factor for minor PPH and may be a better predictor of PPH than antenatal risk factors. Women with operative births are often excluded from trials meaning a lack of data supporting interventions in these women. More focus on complex births is needed to ensure the evidence base is relevant to the target population.

Post-partum haemorrhage (PPH) is a significant cause of maternal mortality in Zimbabwe and Africa. Despite easy access and availability of oxytocin to treat PPH, incidence cases of maternal mortality from PPH still occur, thus additional interventions are needed to prevent PPH. This parallel, double-blind, closed label randomized clinical trial was carried out to determine the efficacy of prophylactic administration of tranexamic acid (TXA) before caesarean section to prevent PPH. In a blinded, 2-centre, randomized control trial with 2 parallel groups that enrolled 1,224 participants who had an elective or emergency caesarean delivery at term, we randomly assigned them to receive 1 g (10 mL) of TXA or 10 mL normal saline at the onset of skin incision. All participants in the study and control group received the standard care of 5 IU intravenous oxytocin on delivery of the baby. The primary outcome was occurrence of PPH, defined by an estimated blood loss exceeding 1,000 mL using laboratory haematocrit values taken before and after the procedure. Six-hundred and thirteen (613) participants were randomized to receive placebo and 611 received TXA. Adjusted analysis from a generalized linear model showed that there was no statistically significant association between the risk of PPH and TXA administration (adjusted relative risk = 1.07; 95% confidence interval = 0.87–1.31). There was no effect modification by type of caesarean section, whether a participant had an emergency or elective caesarean section. TXA did not cause significant adverse events during the clinical trial. Prophylactic administration of TXA before a caesarean section did not significantly reduce the risk of PPH compared to standard methods alone.