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2.
Nurs Open ; 11(6): e2221, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38923309

RESUMEN

AIMS: To establish a comprehensive understanding of the roles of midwives and the challenges they encounter in the prevention, diagnosis and management of postpartum haemorrhage (PPH) following normal vaginal delivery. DESIGN: We conducted a scoping review following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR) recommendations. METHODS: We considered studies related to the roles of midwives and the challenges they encounter in the prevention, diagnosis and management of PPH during vaginal delivery. We excluded guidelines, consensuses, abstracts of meetings and non-English language studies. Databases, including the Cochrane Library, PubMed, Web of Science, Ovid, Medline, Embase, JBI EBP and BIOSIS Previews, were searched on January 1, 2023, with no time limitations. RESULTS: We included 28 publications. Midwives play important roles in the prevention, diagnosis and management of postpartum haemorrhage during vaginal delivery. In the prevention of PPH, midwives' roles include identifying and managing high-risk factors, managing labour and implementing skin-to-skin contact. In the diagnosis of PPH, midwives' roles include early recognition and blood loss estimation. In the management of PPH, midwives are involved in mobilizing other professional team members, emergency management, investigating causes, enhancing uterine contractions, the repair of perineal tears, arranging transfers and preparation for surgical intervention. However, midwives face substantial challenges, including insufficient knowledge and skills, poor teamwork skills, insufficient resources and the need to deal with their negative emotions. Midwives must improve their knowledge, skills and teamwork abilities. Health care system managers and the government should give full support to midwives. Future research should focus on developing clinical practice guidelines for midwives for preventing, diagnosing and managing postpartum haemorrhage.


Asunto(s)
Parto Obstétrico , Hemorragia Posparto , Humanos , Hemorragia Posparto/enfermería , Hemorragia Posparto/prevención & control , Hemorragia Posparto/terapia , Femenino , Parto Obstétrico/efectos adversos , Parto Obstétrico/enfermería , Embarazo , Partería , Enfermeras Obstetrices
3.
PLoS One ; 19(6): e0303844, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38861495

RESUMEN

Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, in 2017, the mortality ratio was 462 out of every 100 000 live births, over 10 times higher than for high-resource settings. There are different treatments available for post-partum haemorrhage. The intrauterine balloon tamponade is a medical device that proved to be a simple and cost-effective approach. Currently, there are several balloon tamponades available, with different design and working principles. However, all these devices were designed for high-resource settings, presenting several aspects that could be inappropriate for many lower-income countries. This paper presents the results of a preclinical study aiming at informing the design, prototyping and validation of a 3D-printed intrauterine balloon tamponade concept, contributing towards the United Nation's Sustainable Development Goal 3: Good health and Well-being. Frugal engineering concepts and contextualised design techniques were applied throughout, to define the design requirements and specifications. The performance of the final prototype was validated against the requirements of the UK National Health System (NHS) technical guidelines and relevant literature, measuring the water leak and pressure drop over time, both open air and in a approximate uterus model. The resulting prototype is made up of six components, some of which are easy to retrieve, namely a water bottle, a silicone tube and an ordinary condom, while others can be manufactured locally using 3D printers, namely a modified bottle cap, a flow stopper and a valve for holding the condom in place. Validation testing bore promising results with no water or pressure leak open air, and minimal leaks in the approximate uterus model. This demonstrates that the 3D printed condom-based intrauterine balloon tamponade is performing well against the requirements and, when compared to the state of the art, it could be a more appropriate and more resilient solution to low-resource settings, as it bypasses the challenges in the supply of consumables and presents a greener option based on circular economy.


Asunto(s)
Diseño de Equipo , Hemorragia Posparto , Impresión Tridimensional , Taponamiento Uterino con Balón , Femenino , Humanos , Taponamiento Uterino con Balón/instrumentación , Taponamiento Uterino con Balón/métodos , Hemorragia Posparto/terapia , Hemorragia Posparto/prevención & control , Condones , Embarazo
4.
Hum Reprod ; 39(6): 1231-1238, 2024 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-38719783

RESUMEN

STUDY QUESTION: What are the pregnancy and obstetric outcomes in women with atypical hyperplasia (AH) or early-stage endometrial cancer (EC) managed conservatively for fertility preservation? SUMMARY ANSWER: The study found a live birth rate of 62% in patients with AH or EC after conservative treatment, with higher level of labour induction, caesarean section, and post-partum haemorrhage. WHAT IS KNOWN ALREADY: Fertility-sparing treatment is a viable option for women with AH or EC during childbearing years, but the outcomes of such treatments, especially regarding pregnancy and obstetrics, need further exploration. STUDY DESIGN, SIZE, DURATION: This retrospective cohort study analysed data from January 2010 to October 2022, involving 269 patients from the French national register of patients with fertility-sparing management of AH/EC. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women above 18 years of age, previously diagnosed with AH/EC, and approved for fertility preservation were included. Patients were excluded if they were registered before 2010, if their treatment began <6 months before the study, or if no medical record on the pregnancy was available. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 95 pregnancies in 67 women were observed. Pregnancy was achieved using ART in 63 cases (66%) and the live birth rate was 62%, with early and late pregnancy loss at 26% and 5%, respectively. In the 59 cases resulting in a live birth, a full-term delivery occurred in 90% of cases; 36% of cases required labour induction and 39% of cases required a caesarean section. The most common maternal complications included gestational diabetes (17%) and post-partum haemorrhaging (20%). The average (±SD) birthweight was 3110 ± 736 g; there were no significant foetal malformations in the sample. No significant difference was found in pregnancy or obstetric outcomes between ART-obtained and spontaneous pregnancies. However, the incidence of induction of labour, caesarean section, and post-partum haemorrhage appears higher than in the general population. LIMITATIONS, REASONS FOR CAUTION: The retrospective nature of the study may introduce bias, and the sample size might be insufficient for assessing rare obstetric complications. WIDER IMPLICATIONS OF THE FINDINGS: This study offers valuable insights for healthcare providers to guide patients who received fertility-sparing treatments for AH/EC. These pregnancies can be successful and with an acceptable live birth rate, but they seem to be managed with caution, leading to possible tendency for more caesarean sections and labour inductions. No increase in adverse obstetric outcomes was observed, with the exception of suspicion of a higher risk of post-partum haemorrhaging, to be confirmed. STUDY FUNDING/COMPETING INTEREST(S): No funding was received for this study. There are no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: N/A.


Asunto(s)
Cesárea , Neoplasias Endometriales , Preservación de la Fertilidad , Resultado del Embarazo , Humanos , Femenino , Embarazo , Preservación de la Fertilidad/métodos , Adulto , Estudios Retrospectivos , Neoplasias Endometriales/terapia , Neoplasias Endometriales/complicaciones , Hiperplasia Endometrial/terapia , Hiperplasia Endometrial/complicaciones , Nacimiento Vivo , Índice de Embarazo , Hemorragia Posparto/epidemiología , Hemorragia Posparto/etiología , Hemorragia Posparto/prevención & control , Francia/epidemiología , Tasa de Natalidad , Tratamiento Conservador/métodos , Trabajo de Parto Inducido , Técnicas Reproductivas Asistidas
6.
Sci Rep ; 14(1): 10004, 2024 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-38693193

RESUMEN

The 3.1 target of the Sustainable Development Goals of the United Nations aims to reduce the global maternal mortality ratio to less than 70 maternal deaths per 100,000 live births by 2030. The last updates on this target show a significant stagnation in the data, thus reducing the chance of meeting it. What makes this negative result even more serious is that these maternal deaths could be avoided through prevention and the wider use of pharmacological strategies and devices to stop postpartum haemorrhage (PPH). PPH is the leading obstetric cause of maternal mortality in low- and middle-income countries (LMICs). Despite low-cost devices based on the uterine balloon tamponade (UBT) technique are already available, they are not safe enough to guarantee the complete stop of the bleeding. When effective, they are too expensive, especially for LMICs. To address this issue, this study presents the design, mechanical characterisation and technology assessment performed to validate a novel low-cost UBT kit, particularly a novel component, i.e., the connector, which guarantees the kit's effectiveness and represents the main novelty. Results proved the device's effectiveness in stopping PPH in a simulated scenario. Moreover, economic and manufacturing evaluations demonstrated its potential to be adopted in LMICs.


Asunto(s)
Países en Desarrollo , Mortalidad Materna , Hemorragia Posparto , Taponamiento Uterino con Balón , Humanos , Femenino , Taponamiento Uterino con Balón/economía , Taponamiento Uterino con Balón/métodos , Taponamiento Uterino con Balón/instrumentación , Hemorragia Posparto/terapia , Hemorragia Posparto/mortalidad , Hemorragia Posparto/prevención & control , Hemorragia Posparto/economía , Embarazo
7.
J Nurs Care Qual ; 39(3): 286-292, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38747711

RESUMEN

BACKGROUND: Postpartum hemorrhage (PPH) is a leading cause of maternity mortality in the United States. The Code Crimson project aimed to enhance PPH management by implementing a standardized intervention bundle to mitigate morbidity and mortality associated with PPH. LOCAL PROBLEM: At a large Philadelphia tertiary hospital, health disparities existed for severe maternal morbidity and mortality, and PPH was a significant factor. METHODS: A quality improvement design, using Plan-Do-Study-Act cycles and interrupted time series analysis, was undertaken. INTERVENTIONS: The Code Crimson project implemented a standardized bundle to manage PPH, including blood product administration and massive transfusion protocol activation. RESULTS: After implementing the Code Crimson bundle, there was a significant decrease in blood product use ( P < .001), with minor reductions in packed red blood cell administration over 4 units and mean blood loss. CONCLUSIONS: The Code Crimson bundle effectively reduced blood product utilization for PPH treatment.


Asunto(s)
Hemorragia Posparto , Mejoramiento de la Calidad , Humanos , Hemorragia Posparto/terapia , Hemorragia Posparto/prevención & control , Femenino , Embarazo , Transfusión Sanguínea , Philadelphia , Análisis de Series de Tiempo Interrumpido , Paquetes de Atención al Paciente/normas , Paquetes de Atención al Paciente/métodos , Adulto
8.
BMC Pregnancy Childbirth ; 24(1): 260, 2024 Apr 11.
Artículo en Inglés | MEDLINE | ID: mdl-38605330

RESUMEN

OBJECTIVE: The objective was to assess the efficacy and safety of low-dose aspirin for the prevention of preterm birth in nulliparous women. DATA SOURCES: We searched PubMed, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to June 2022. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials that compared aspirin to placebo in nulliparous women were eligible. METHODS: This study was reported in accordance with the PRISMA 2020 checklist. The primary outcomes of this study were the rates of preterm birth at less than 37 weeks and less than 34 weeks of gestation. The secondary outcomes included postpartum hemorrhage, placental abruption, cesarean section, any hypertensive disorder of pregnancy and small for gestational age. Relative risks with their 95% confidence intervals were calculated for analysis. Heterogeneity was assessed by Cochran's Q test and Higgins's I2. A random-effects model was used when I2 was > 50% to generate the RR and 95% CI; otherwise, a fixed-effects model was used. The risk of publication bias was assessed by funnel plots. We performed sensitivity analysis by sequentially omitting each included study to confirm the robustness of the analysis. RESULTS: Seven studies with a total of 29,029 participants were included in this review. Six studies were assessed as having a low risk of bias or an unclear risk of bias, and one study was judged as having a high risk of bias. In nulliparous women, low-dose aspirin was associated with a significant reduction in the rate of preterm birth at less than 34 weeks of gestational age (RR 0.84,95% CI: 0.71-0.99; I2 = 0%; P = 0.04), but we did not observe a significant difference in the rate of preterm birth at less than 37 weeks of gestation (RR 0.96,95% CI: 0.90-1.02; I2 = 31%; P = 0.18). Low-dose aspirin was associated with a significant increase in the rates of postpartum hemorrhage (RR 1.32,95% CI: 1.14-1.54; I2 = 0%; P = 0.0003), placental abruption (RR 2.18,95% CI: 1.10-4.32; I2 = 16%; P = 0.02) and cesarean section (RR 1.053, 95% CI: 1.001-1.108; I2 = 0%; P = 0.05) in nulliparous women. We also did not observe a significant effect of low-dose aspirin on the rates of any hypertensive disorder of pregnancy (RR 1.05, 95% CI: 0.96-1.14; I2 = 9%; P = 0.28) or small for gestational age (RR 0.96, 95% CI: 0.91-1.02; I2 = 0%; P = 0.16) in nulliparous women. Funnel plots indicated that no significant publication bias existed in this meta-analysis. Except for preterm birth at less than 34 weeks of gestation, placental abruption and cesarean section, the sensitivity analysis showed similar results, which confirmed the robustness of this meta-analysis. CONCLUSIONS: Low-dose aspirin might reduce the risk of preterm birth at less than 34 weeks of gestation in nulliparous women. The use of low-dose aspirin in nulliparous women increased the risk of postpartum hemorrhage and might increase the risk of placental abruption and cesarean section.


Asunto(s)
Desprendimiento Prematuro de la Placenta , Hipertensión , Hemorragia Posparto , Nacimiento Prematuro , Femenino , Embarazo , Recién Nacido , Humanos , Nacimiento Prematuro/epidemiología , Nacimiento Prematuro/prevención & control , Nacimiento Prematuro/tratamiento farmacológico , Desprendimiento Prematuro de la Placenta/epidemiología , Desprendimiento Prematuro de la Placenta/prevención & control , Cesárea , Hemorragia Posparto/epidemiología , Hemorragia Posparto/prevención & control , Hemorragia Posparto/tratamiento farmacológico , Placenta , Aspirina , Hipertensión/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto
9.
J Gynecol Obstet Hum Reprod ; 53(5): 102761, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38431190

RESUMEN

OBJECTIVE: To prevent post-partum haemorrhage (PPH), national and international guidelines recommend the administration of a prophylactic injection of oxytocin after all vaginal births. Although additional maintenance oxytocin is not recommended in the immediate postpartum, its administration is quite common (30 % of French births in 2021). To assess in a single center, the frequency and determinants associated with the administration of maintenance oxytocin in immediate postpartum. STUDY DESIGN: A retrospective observational single-centre study was conducted in a tertiary-care university centre in Paris (France), with data from April-May 2022. All women who gave birth vaginally at or after 37 weeks, except for those with immediate PPH. Univariate and multivariate analysis were performed to compare determinants between the group receiving maintenance oxytocin and the control group without this intervention. A sensitivity analysis in a population of women at low risk of PPH was performed. Maternal, obstetrical, perinatal and organisational determinants were collected. RESULTS: This study included 584 patients, 278 (47.6 %) of whom received maintenance oxytocin. We observed a significantly higher rate of maintenance oxytocin administration to parous women (OR 1.57, 90 %CI 1.09-2.27) and women with a history of PPH (OR 2.88, 90 %CI 1.08-9.08). Additional maintenance oxytocin was also administered more often when the midwife handling the birth had more than 5 years of practice since completion of training (OR 1.77, 1.24-2.53) or during night-time births (OR 1.47, 90 %CI 1.03-2.10). CONCLUSION: Maintenance oxytocin administration is a frequent practice, performed for almost half the patients in our center. This practice is associated with maternal and obstetric factors, but also with health professionals' individual decisions and practices.


Asunto(s)
Oxitócicos , Oxitocina , Hemorragia Posparto , Humanos , Oxitocina/administración & dosificación , Femenino , Estudios Retrospectivos , Hemorragia Posparto/prevención & control , Hemorragia Posparto/epidemiología , Adulto , Oxitócicos/administración & dosificación , Embarazo , Periodo Posparto , Centros de Atención Terciaria/estadística & datos numéricos , Paris/epidemiología , Francia/epidemiología
10.
J Vasc Interv Radiol ; 35(6): 895-899, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38492660

RESUMEN

Internal iliac artery (IIA) balloon occlusion catheters have been commonly inserted to decrease the risk of postpartum hemorrhage in placenta accreta spectrum disorders; however, there has been mixed success in clinical studies. Placement of an infrarenal aortic balloon has shown more consistent effectiveness in recent studies. A possible reason for this is collateral arterial supply to the placenta from external iliac artery branches. Retrospective chart review was conducted of angiography images during prophylactic IIA balloon occlusion catheter insertion over a 7-year period. Sixty-two individual cases were identified. Digital subtraction angiography (DSA) was performed in 32 (52%) cases, and 20 (62%) showed collateral blood supply from branches of the external iliac arteries, namely the round ligament artery. In conclusion, a high proportion of placenta accreta spectrum cases have arterial blood supply from branches of the external iliac artery, which may explain the discrepancy in effectiveness seen between IIA and infrarenal aortic sites of balloon occlusion catheter placement.


Asunto(s)
Angiografía de Substracción Digital , Oclusión con Balón , Circulación Colateral , Arteria Ilíaca , Placenta Accreta , Humanos , Femenino , Oclusión con Balón/efectos adversos , Placenta Accreta/diagnóstico por imagen , Placenta Accreta/terapia , Embarazo , Estudios Retrospectivos , Arteria Ilíaca/diagnóstico por imagen , Adulto , Resultado del Tratamiento , Hemorragia Posparto/prevención & control , Hemorragia Posparto/etiología , Placenta/irrigación sanguínea , Flujo Sanguíneo Regional
11.
Medicine (Baltimore) ; 103(11): e37533, 2024 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-38489705

RESUMEN

OBJECTIVE: To investigate the effect of Bakri balloon tamponade (BBT) combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension (PIH) undergoing cesarean delivery (CD). METHODS: This randomized, double-blind, controlled trial was conducted at The First Affiliated Hospital of Xingtai Medical College from October 2020 to June 2023. Patients with PIH who had persistent bleeding after CD and were unresponsive to uterine contractions, sutures, or uterine disconnection procedures were eligible participants. Eligible participants were randomly assigned to control and study groups, with 50 patients in each group. The control group used BBT combined with B-lynch uterine compression sutures, while the study group used BBT combined with modified Hayman suture. Intraoperative and postoperative bleeding and changes in vital signs were compared between the 2 groups. Moreover, changes in inflammation levels, coagulation function, and sex hormone levels were compared between the 2 groups before and after surgery. RESULTS: A total of 122 patients with persistent bleeding after CD were recruited, of whom 22 were excluded (16 cases of uterine contractions and/or local uterine myometrial sutures for hemostasis, 4 cases of preoperative uterine artery embolization, and 2 cases of uterine malformations). The intraoperative blood loss, postoperative blood loss at 2 hours, postoperative blood loss at 24 hours, and decrease in red blood cell and hemoglobin in the study group were significantly lower than those in the control group (P < .05). After surgery, the levels of inflammation, coagulation function, and sex hormone in both groups improved compared to before surgery, and the study group was significantly better than the control group (P < .05). In addition, the incidence of postoperative adverse events in the study group was significantly lower than that in the control group (P < .05). CONCLUSIONS: The hemostatic effect of BBT combined with B-lynch uterine compression sutures is comparable to that of BBT combined with modified Hayman suture for postpartum hemorrhage in pregnant women with PIH undergoing CD, but the latter has less blood loss, attenuated inflammatory response, reduced impact on coagulation function and ovarian function, and a lower incidence of adverse events.


Asunto(s)
Hipertensión Inducida en el Embarazo , Hemorragia Posparto , Taponamiento Uterino con Balón , Femenino , Humanos , Embarazo , Hormonas Esteroides Gonadales , Hipertensión Inducida en el Embarazo/cirugía , Inflamación/complicaciones , Hemorragia Posoperatoria/cirugía , Hemorragia Posparto/etiología , Hemorragia Posparto/prevención & control , Estudios Retrospectivos , Técnicas de Sutura , Suturas , Taponamiento Uterino con Balón/métodos
13.
Can J Anaesth ; 71(4): 465-478, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38453797

RESUMEN

PURPOSE: Postpartum hemorrhage (PPH) is a leading cause of maternal mortality worldwide. Although several studies on the prophylactic use of tranexamic acid (TXA) in parturients undergoing Cesarean delivery have been published, conflicting results raise questions regarding its use. Thus, we aimed to investigate the safety and efficacy of PPH prophylaxis with TXA. SOURCE: We searched PubMed®, Embase, Cochrane Central, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing prophylactic TXA with placebo or no treatment in parturients undergoing Cesarean delivery. Our main outcomes were PPH, any blood transfusion, need for additional uterotonics, and adverse events. We performed a trial sequential analysis (TSA) of all outcomes to investigate the reliability and conclusiveness of findings. PRINCIPAL FINDINGS: We included 38 RCTs including 22,940 parturients, 11,535 (50%) of whom were randomized to receive prophylactic TXA. Patients treated with TXA had significantly fewer cases of PPH (risk ratio [RR], 0.51; 95% confidence interval [CI], 0.38 to 0.69; P < 0.001); less blood transfusion (RR, 0.43; 95% CI, 0.30 to 0.61; P < 0.001), and less use of additional uterotonics (RR, 0.52; 95% CI, 0.40 to 0.68; P < 0.001). No significant differences were found between the groups in terms of adverse effects and thromboembolic events. CONCLUSION: Prophylactic TXA administration for parturients undergoing Cesarean delivery significantly reduced blood loss, without increasing adverse events, supporting its use as a safe and effective strategy for reducing PPH in this population. STUDY REGISTRATION: PROSPERO (CRD42023422188); first submitted 27 April 2023.


RéSUMé: OBJECTIF: L'hémorragie du post-partum (HPP) est l'une des principales causes de mortalité maternelle dans le monde. Bien que plusieurs études sur l'utilisation prophylactique d'acide tranexamique (TXA) chez les personnes parturientes ayant accouché par césarienne aient été publiées, des résultats contradictoires soulèvent des questions quant à son utilisation. Ainsi, nous avons cherché à étudier l'innocuité et l'efficacité de la prophylaxie à base de TXA pour l'HPP. SOURCES: Nous avons fait une recherche sur PubMed®, Embase, Cochrane Central et ClinicalTrials.gov pour en tirer les études randomisées contrôlées (ERC) comparant le TXA prophylactique à un placebo ou à l'absence de traitement chez les personnes parturientes accouchant par césarienne. Nos principaux critères d'évaluation étaient l'HPP, toute transfusion sanguine, la nécessité d'un utérotonique supplémentaire et les événements indésirables. Nous avons effectué une analyse séquentielle des études pour tous les résultats afin d'examiner la fiabilité et le caractère concluant des conclusions. CONSTATATIONS PRINCIPALES: Nous avons inclus 38 ERC comprenant 22 940 personnes parturientes, dont 11 535 (50 %) ont été randomisées pour recevoir du TXA prophylactique. La patientèle traitée par TXA présentait significativement moins de cas d'HPP (risque relatif [RR], 0,51; intervalle de confiance [IC] à 95 %, 0,38 à 0,69; P < 0,001); moins de transfusion sanguine (RR, 0,43; IC 95 %, 0,30 à 0,61; P < 0,001) et moins d'utilisation d'utérotoniques supplémentaires (RR, 0,52; IC 95 %, 0,40 à 0,68; P < 0,001). Aucune différence significative n'a été constatée entre les groupes en termes d'effets indésirables et d'événements thromboemboliques. CONCLUSION: L'administration prophylactique de TXA pour les personnes parturientes accouchant par césarienne a considérablement réduit les pertes de sang sans augmenter les événements indésirables, ce qui soutient son utilisation comme stratégie sécuritaire et efficace pour réduire l'HPP dans cette population. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42023422188); première soumission le 27 avril 2023.


Asunto(s)
Antifibrinolíticos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Hemorragia Posparto , Ácido Tranexámico , Embarazo , Femenino , Humanos , Ácido Tranexámico/uso terapéutico , Hemorragia Posparto/prevención & control , Hemorragia Posparto/epidemiología , Cesárea , Transfusión Sanguínea , Antifibrinolíticos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto
14.
Am J Obstet Gynecol ; 231(1): 128.e1-128.e11, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38346912

RESUMEN

BACKGROUND: Venous thromboembolism accounts for approximately 9% of pregnancy-related deaths in the United States. National guidelines recommend postpartum risk stratification and pharmacologic prophylaxis in at-risk individuals. Knowledge on modern rates of postpartum pharmacologic thromboprophylaxis and its associated risks is limited. OBJECTIVE: This study aimed to describe the rate of, and factors associated with, initiation of postpartum pharmacologic prophylaxis for venous thromboembolism, and to assess associated adverse outcomes. STUDY DESIGN: This was a secondary analysis of a multicenter cohort of individuals delivering on randomly selected days at 17 US hospitals (2019-2020). Medical records were reviewed by trained and certified personnel. Those with an antepartum diagnosis of venous thromboembolism, receiving antepartum anticoagulation, or known SARS-CoV-2 infection were excluded. The primary outcome was use of postpartum pharmacologic thromboprophylaxis. Secondary outcomes included bleeding complications, surgical site infection, hospital readmission, and venous thromboembolism through 6 weeks postpartum. The rate of thromboprophylaxis administration was assessed by mode of delivery, institution, and continuance to the outpatient setting. Multivariable regression models were developed using k-fold cross-validation with stepwise backward elimination to evaluate factors associated with thromboprophylaxis administration. Univariable and multivariable logistic models with propensity score covariate adjustment were performed to assess the association between thromboprophylaxis administration and adverse outcomes. RESULTS: Of 21,114 individuals in the analytical cohort, 11.9% (95% confidence interval, 11.4%-12.3%) received postpartum pharmacologic thromboprophylaxis; the frequency of receipt was 29.8% (95% confidence interval, 28.7%-30.9%) following cesarean and 3.5% (95% confidence interval, 3.2%-3.8%) following vaginal delivery. Institutional rates of prophylaxis varied from 0.21% to 34.8%. Most individuals (83.3%) received thromboprophylaxis only as inpatients. In adjusted analysis, cesarean delivery (adjusted odds ratio, 19.17; 95% confidence interval, 16.70-22.00), hysterectomy (adjusted odds ratio, 15.70; 95% confidence interval, 4.35-56.65), and obesity (adjusted odds ratio, 3.45; 95% confidence interval, 3.02-3.95) were the strongest factors associated with thromboprophylaxis administration. Thromboprophylaxis administration was not associated with surgical site infection (0.9% vs 0.6%; odds ratio, 1.48; 95% confidence interval, 0.80-2.74), bleeding complications (0.2% vs 0.1%; odds ratio, 2.60; 95% confidence interval, 0.99-6.80), or postpartum readmission (0.9% vs 0.3%; adjusted odds ratio, 1.38; 95% confidence interval, 0.68-2.81). The overall rate of venous thromboembolism was 0.06% (95% confidence interval, 0.03%-0.10%) and was higher in those receiving prophylaxis (0.2%) compared with those not receiving prophylaxis (0.04%). CONCLUSION: Approximately 1 in 10 patients received postpartum pharmacologic thromboprophylaxis in this US cohort. Rates of prophylaxis varied widely by institution. Cesarean delivery, hysterectomy, and obesity were predominant factors associated with postpartum thromboprophylaxis administration.


Asunto(s)
Tromboembolia Venosa , Humanos , Femenino , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/epidemiología , Adulto , Embarazo , Estados Unidos/epidemiología , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Periodo Posparto , Readmisión del Paciente/estadística & datos numéricos , Estudios de Cohortes , Infección de la Herida Quirúrgica/prevención & control , Infección de la Herida Quirúrgica/epidemiología , Cesárea , Hemorragia Posparto/prevención & control , Hemorragia Posparto/epidemiología , Trastornos Puerperales/prevención & control , Trastornos Puerperales/epidemiología , Estudios Retrospectivos
15.
Am J Obstet Gynecol ; 231(1): 67-91, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38336124

RESUMEN

OBJECTIVE: Care bundles are a promising approach to reducing postpartum hemorrhage-related morbidity and mortality. We assessed the effectiveness and safety of care bundles for postpartum hemorrhage prevention and/or treatment. DATA SOURCES: We searched MEDLINE, Embase, Cochrane CENTRAL, Maternity and Infant Care Database, and Global Index Medicus (inception to June 9, 2023) and ClinicalTrials.gov and the International Clinical Trials Registry Platform (last 5 years) using a phased search strategy, combining terms for postpartum hemorrhage and care bundles. STUDY ELIGIBILITY CRITERIA: Peer-reviewed studies evaluating postpartum hemorrhage-related care bundles were included. Care bundles were defined as interventions comprising ≥3 components implemented collectively, concurrently, or in rapid succession. Randomized and nonrandomized controlled trials, interrupted time series, and before-after studies (controlled or uncontrolled) were eligible. METHODS: Risk of bias was assessed using RoB 2 (randomized trials) and ROBINS-I (nonrandomized studies). For controlled studies, we reported risk ratios for dichotomous outcomes and mean differences for continuous outcomes, with certainty of evidence determined using GRADE. For uncontrolled studies, we used effect direction tables and summarized results narratively. RESULTS: Twenty-two studies were included for analysis. For prevention-only bundles (2 studies), low-certainty evidence suggests possible benefits in reducing blood loss, duration of hospitalization, and intensive care unit stay, and maternal well-being. For treatment-only bundles (9 studies), high-certainty evidence shows that the E-MOTIVE intervention reduced risks of composite severe morbidity (risk ratio, 0.40; 95% confidence interval, 0.32-0.50) and blood transfusion for bleeding, postpartum hemorrhage, severe postpartum hemorrhage, and mean blood loss. One nonrandomized trial and 7 uncontrolled studies suggest that other postpartum hemorrhage treatment bundles might reduce blood loss and severe postpartum hemorrhage, but this is uncertain. For combined prevention/treatment bundles (11 studies), low-certainty evidence shows that the California Maternal Quality Care Collaborative care bundle may reduce severe maternal morbidity (risk ratio, 0.64; 95% confidence interval, 0.57-0.72). Ten uncontrolled studies variably showed possible benefits, no effects, or harms for other bundle types. Nearly all uncontrolled studies did not use suitable statistical methods for single-group pretest-posttest comparisons and should thus be interpreted with caution. CONCLUSION: The E-MOTIVE intervention improves postpartum hemorrhage-related outcomes among women delivering vaginally, and the California Maternal Quality Care Collaborative bundle may reduce severe maternal morbidity. Other bundle designs warrant further effectiveness research before implementation is contemplated.


Asunto(s)
Paquetes de Atención al Paciente , Hemorragia Posparto , Humanos , Hemorragia Posparto/prevención & control , Hemorragia Posparto/terapia , Femenino , Embarazo
17.
Eur J Obstet Gynecol Reprod Biol ; 295: 172-180, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38367391

RESUMEN

1. OBJECTIVE: To perform a network meta-analysis to specify the route of administration that maximises the effectiveness of each of the available prophylactic uterotonics without increasing the risk for side effects. 2. DATA SOURCES: Literature searches on 12th September 2022 included: CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. The reference lists of the retrieved study records were also searched. 3. STUDY ELIGIBILITY CRITERIA: Population: Randomized controlled trials involving women in the third stage of labour after a vaginal or caesarean delivery in hospital or community settings. INTERVENTIONS: Systemically administered prophylactic uterotonics of any route and dose for primary postpartum hemorrhage prevention. Comparison: Any other prophylactic uterotonic, or a different route or dose of a given uterotonic, or placebo, or no treatment. Outcomes (primary): postpartum hemorrhage ≥ 500 mL and ≥ 1000 mL. 4. STUDY APPRAISAL AND SYNTHESIS METHODS: Risk of bias and trustworthiness assessments were performed, according to Cochrane's guidance. Direct, indirect and network meta-analyses were conducted, and results were summarized either as risk ratio or mean difference with 95% confidence intervals for dichotomous and continuous outcomes, respectively. The certainty of generated evidence was assessed according to the GRADE approach. Cumulative probabilities were calculated and the surface under the cumulative ranking curve was used to create a ranking of the available drugs. 5. RESULTS: One hundred eighty-one studies involving 122,867 randomised women were included. Most studies were conducted in hospital settings in lower-middle income countries and involved women delivering vaginally. When compared with intramuscular oxytocin, carbetocin (RR 0.58, 95 % CI 0.40-0.84) and oxytocin (RR 0.75, 95 % CI 0.59-0.97) by an intravenous bolus, and intramuscular ergometrine plus oxytocin combination (RR 0.71, 95 % CI 0.56-0.91) are probably more effective in preventing primary postpartum hemorrhage. Intramuscularly administered oxytocin and carbetocin by an intravenous bolus have a favourable side effects profile. 6. CONCLUSIONS: Generated evidence was generally moderate and global inconsistency was low. Carbetocin and oxytocin by an intravenous bolus, and intramuscular ergometrine plus oxytocin combination are probably the top uterotonics for primary postpartum hemorrhage prevention. Large scale studies exploring different routes of administration for available prophylactic uterotonics, and women's views should be conducted.


Asunto(s)
Oxitócicos , Hemorragia Posparto , Embarazo , Femenino , Humanos , Hemorragia Posparto/prevención & control , Hemorragia Posparto/tratamiento farmacológico , Oxitocina , Ergonovina/uso terapéutico , Metaanálisis en Red , Tercer Periodo del Trabajo de Parto , Ensayos Clínicos Controlados Aleatorios como Asunto
18.
Curr Opin Obstet Gynecol ; 36(2): 88-96, 2024 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-38170626

RESUMEN

PURPOSE OF REVIEW: Tranexamic acid (TXA) has emerged as a promising pharmacological adjunct to treat and prevent postpartum hemorrhage (PPH). We provide an overview of TXA, including its pharmacology, key findings of randomized trials and observational studies, and critical patient safety information. RECENT FINDINGS: Pharmacokinetic data indicate that TXA infusions result in peak plasma concentration within 3 min (range: 1-6.6 min). Ex-vivo pharmacodynamic data suggest that low-dose TXA (5 mg/kg) inhibits maximum lysis for at least 1 h. In predominantly developing countries, TXA has demonstrated a 19% reduction in the risk of bleeding-related death among patients with PPH. Based on high-quality randomized trials, TXA prophylaxis does not effectively reduce the risk of PPH during vaginal delivery and is likely ineffective in reducing the PPH risk during cesarean delivery. TXA exposure does not increase the risk of maternal thrombotic events. Maternal deaths have occurred from accidental intrathecal TXA injection from look-alike medication errors. SUMMARY: TXA has shown promise as an important adjunct for PPH treatment, especially in low-resource settings. However, TXA is not recommended as PPH prophylaxis during vaginal or cesarean delivery. Patient safety initiatives should be prioritized to prevent maternal death from accidental intrathecal TXA injection.


Asunto(s)
Antifibrinolíticos , Hemorragia Posparto , Ácido Tranexámico , Embarazo , Femenino , Humanos , Ácido Tranexámico/uso terapéutico , Antifibrinolíticos/uso terapéutico , Hemorragia Posparto/tratamiento farmacológico , Hemorragia Posparto/prevención & control , Parto Obstétrico , Cesárea
19.
Womens Health (Lond) ; 20: 17455057231225311, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38279808

RESUMEN

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.


Asunto(s)
Antifibrinolíticos , Hemorragia Posparto , Ácido Tranexámico , Recién Nacido , Femenino , Embarazo , Humanos , Hemorragia Posparto/prevención & control , Hemorragia Posparto/tratamiento farmacológico , Hemorragia Posparto/etiología , Ácido Tranexámico/uso terapéutico , Cesárea/efectos adversos , Pérdida de Sangre Quirúrgica/prevención & control , Antifibrinolíticos/uso terapéutico , Nigeria , Método Doble Ciego , Hemoglobinas
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