Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are At Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage, in Advance of Delivery/birth

Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml (abnormal postpartum uterine bleeding) or cumulative blood loss of ≥1000ml (postpartum haemorrhage) at least 1 hour in advance of birth. This study is being undertaken to assess the performance of Oli measuring cumulative blood loss ≥500ml and ≥1000ml, as well as evaluate its safety profile.

开始日期2025-01-28

申办/合作机构

Royal North Shore Hospital

NCT06650930 / Not yet recruiting早期临床1期IIT

Pharmacokinetics of Oral Calcium Carbonate in Parturients

This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "Tums"). This information is important for trials investigating whether calcium can reduce postpartum hemorrhage, bleeding after delivery.

开始日期2025-01-01

申办/合作机构

Stanford University

NCT05127642 / Not yet recruitingN/AIIT

Hemostatic Assessment of Postpartum Hemorrhage Cases Using Sonoclot Signature

Postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. Rapid diagnosis and early management improve maternal prognosis.
Postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery.
There are many causes of postpartum hemorrhage. Most cases develop from uterine atony, which accounts for 75% of cases. Even though there are risk factors for postpartum hemorrhage, it is still an unpredictable obstetric emergency.
Coagulation plays an important role in postpartum hemostasis. Primary and especially secondary coagulation disorders are risk factors for Postpartum hemorrhage.
When bleeding occurs, the decrease in fibrinogen levels is the most rapid change observed among markers of coagulation. Recent studies show that fibrinogen concentration during the initial management of Postpartum hemorrhage is the most informative biological marker for the severity of the hemorrhage.
Various methods are used to record coagulation profile. One of them is estimation by sonoclot.
Viscoelastic hemostatic assays devices (such as sonoclot) have practical advantages as point-of-care devices for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile like fibrinogen and platelet count.
Identification of coagulopathy by viscoelastic point-of-care testing can be helpful in guiding management of Postpartum hemorrhage and preventing severe maternal outcomes.

开始日期2024-12-01

申办/合作机构

Assiut University

100 项与子宫出血相关的临床结果

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100 项与子宫出血相关的转化医学

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0 项与子宫出血相关的专利（医药）

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26,291

项与子宫出血相关的文献（医药）

2025-02-01·International Journal of Obstetric Anesthesia

Obstetric hemorrhage risk assessment using the maximum allowable blood loss calculation: are we on the right track?

Letter

作者: Chau, Anthony ; Sutherland, Eduardo ; Villar, Giselle ; Sebbag, Ilana

The clinical guidelines on postpartum hemorrhage from the Society of Obstetricians and Gynaecologists of Canada (SOGC) provide evidence-based recommendations structured around the 6Rs framework: Risk Assessment, Risk Reduction, Recognition and Evaluation, Reaction, Resuscitation, and Review. Since its publication, our institution has begun implementing all the guideline recommendations. One key recommendation is to calculate the Maximum Allowable Blood Loss (MABL) to reach a hemoglobin level of 70 g/L for every obstetric patient. This practice was introduced to promote an individualized approach to hemorrhage risk assessment, accounting for variations in patients' anthropometric characteristics. However, there is currently a lack of evidence supporting the use of MABL calculation in the obstetric population. In this commentary, we highlight the limitations of the MABL calculation through specific examples and propose areas for further research.

2025-02-01·International Journal of Obstetric Anesthesia

Anaesthetic considerations for impacted fetal head at caesarean delivery: a focused review

Review

作者: Ragbourne, S C ; Desai, N ; Ragbourne, S.C. ; Charles, E. ; Charles, E ; Herincs, M. ; Desai, N. ; Herincs, M

BACKGROUNDImpacted fetal head occurs when the fetal head is deeply engaged within the maternal pelvis and difficult to deliver during caesarean delivery. In order to deliver the fetal head, additional surgical manoeuvres and/or pharmacological tocolysis are needed. The aim of this focused review is to outline the incidence, risk factors, management and complications of this obstetric emergency from the perspective of the anaesthetist.METHODSDatabases were searched for free text headings and subject headings associated with different permutations of terms related to impacted fetal head and caesarean delivery.RESULTSImpacted fetal head has been estimated to occur in 1.5 % of elective caesarean deliveries and 2.9-18.4% of all emergency caesarean deliveries at any cervical dilatation. Risk factors include advanced cervical dilatation, labour augmentation with oxytocin, prolonged second stage of labour, fetal malposition and junior grade of operating obstetrician. If impacted fetal head occurs, the anaesthetist in conjunction with the multidisciplinary team should consider decreasing the height of the operating table, providing a step for the obstetrician to stand on, placing the patient in the head down position, providing pharmacological tocolysis with glyceryl trinitrate (or nitroglycerin), beta-2 adrenoreceptor agonists or volatile anaesthetic agents, and managing complications such as postpartum haemorrhage.CONCLUSIONImpacted fetal head is an obstetric emergency that the anaesthetist should be familiar with and has a vital role in managing. We propose an algorithm for management that may serve as a clinical decision aid.

2025-01-01·Journal of Gynecology Obstetrics and Human Reproduction

Risk of postpartum hemorrhage according to the planned mode of delivery among twin pregnancies with previous cesarean delivery

Article

作者: Korb, Diane ; Schmitz, Thomas ; Goffinet, François ; Ray, Camille Le ; Loussert, Lola

INTRODUCTIONBoth twin pregnancies and previous cesarean delivery are situations with increased risk of failed vaginal delivery. Cesarean delivery after a trial of labor is associated with an increased risk of postpartum hemorrhage Therefore, in twin pregnancies with a previous cesarean delivery, planned vaginal delivery could lead to an increased risk of postpartum hemorrhage due to an important rate of cesarean delivery after a trial of labor. Our objective was to evaluate the association between the planned mode of delivery and postpartum hemorrhage in women with twin pregnancies and a previous cesarean delivery.METHODSWe conducted a secondary analysis of the JUMODA French population-based prospective cohort study of twin pregnancies (n = 8823). We included women with one previous cesarean and without contraindication to vaginal birth. The primary outcome was postpartum hemorrhage.RESULTSAmong the 735 women included, 187 women (25.4%) had planned vaginal delivery and 548 (74.6%) had planned cesarean delivery. Among women with planned vaginal delivery, 125 (66.8%) had a successful vaginal delivery. The incidence of PPH was 8.2% in the planned cesarean group and 9.1% in the planned vaginal delivery group(p = 0.709). After adjustment for confounders, the planned mode of delivery was not associated with the risk of postpartum hemorrhage (adjusted relative risk 0.94, 95% CI 0.56-1.60). There were only 2 uterine ruptures, both in the planned cesarean delivery group.CONCLUSIONIn women with a twin pregnancy and a previous cesarean delivery, there is no overall association between the planned mode of delivery and the risk of postpartum hemorrhage.

288

项与子宫出血相关的新闻（医药）

2024-10-29

·药智网

【喜讯】海步医药瑞卢戈利片(40mg)获得临床试验批件

近日，北京海步医药科技有限公司（简称“海步医药”）自主研发的瑞卢戈利片（40mg）获得国家药品监督管理局（NMPA）药品审评中心（CDE）的临床试验默示许可，适应症为改善子宫肌瘤以下症状（月经过多、下腹痛、腰疼、贫血）；改善子宫内膜异位症的疼痛。来源：国家药品监督管理局药品审评中心官网 01 基本信息产品名称：瑞卢戈利片英文名称：Relugolix tablets 剂型/规格：片剂，40mg 适应症：子宫肌瘤症状（月经过多、下腹痛、腰疼、贫血）改善；改善子宫内膜异位症的疼痛注册分类：3类原研：日本武田药品工业株式会社专利概况：化合物专利2024年01月；工艺专利2033年09月 02 作用机制雌激素依赖性失衡是引发育龄妇女子宫肌瘤和子宫内膜异位症的主因。瑞卢戈利是一种口服促性腺激素释放激素（Gonadotropin-releasing hormone, GnRH）受体拮抗剂，可以阻断内源性GnRH与其受体的结合，减少促黄体生成素（Luteinizing hormone, LH）和促卵泡刺激素（Follicle-stimulating hormone, FSH）的释放，抑制卵巢雌二醇和孕酮等性激素分泌，从而可改善子宫肌瘤引起的各种症状。 03 国内外上市情况 2019年01月08在日本批准上市，规格为40mg，用于改善子宫肌瘤的以下症状：月经过多，下腹痛，腰痛，贫血；和子宫内膜异位引起的疼痛。 2020年12月18日在美国（FDA）批准，规格为120mg，用于治疗晚期前列腺癌成人患者。目前原研国内尚未上市。 04 项目优势安全性好，用药灵活：有多种肽类GnRH激动剂或诱导剂等需要通过肌肉或皮下注射给药。而瑞卢戈利是一种新型促性腺激素释放激素（GnRH）拮抗剂，口服给药，每日一次，患者顺应性好，不良反应少。患病人数多，临床需求明确：子宫肌瘤是绝经前女性最常见的良性肿瘤，约占女性生殖器官肿瘤的80%，根据我国相关专家共识，我国育龄期妇女的患病率估计可达25%，患病率高，用药需求大。全球市场呈平稳上升趋势：40mg规格瑞卢戈利片目前仅在日本有销售。全球市场自2019年来呈上升趋势，2022年达到5814万美元，2023年6163万美元，仍保持增长趋势。如果上市国家增加，全球市场会进一步上升。国内市场可观：目前的治疗药物亮丙瑞林2023年中国销售额51亿元。子宫肌瘤和子宫内膜异位都是妇科常见病，我国人口基数庞大，新发病例不断增多，市场空间和潜力大。 END 北京海步医药科技有限公司海步医药成立于2005年，是一家以“化学药物研发”为核心能力的高新技术企业。设有北京研发中心、原料药和制剂中试验证中心、GMP工业化生产基地，主要从事化学药的技术开发与技术转让、MAH研发与持证、原料药关联申报以及医药中间体商业化供应等。公司连续多年获得“中国医药研发公司20强”称号，被评为“北京科技研究开发机构”、“国家高新技术企业”、“北京亦庄企业创新中心”。海步医药在化学原料药、口服固体、液体制剂、无菌注射剂、外用制剂等多种剂型的研发转产、注册申报等方面经验丰富。研发产品涉及抗肿瘤、抗抑郁、抗癫痫、抗焦虑、心脑血管、消化系统、呼吸系统等多个适应症领域，并持续进行创新与改良药物的研究开发。北京总部地址：北京经济技术开发区经海产业园A5座上海分公司地址：上海虹桥商务区绿谷广场C幢201-4 来源 | 海步医药（药智网获取授权转载）责任编辑 | 徐彬傲声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

上市批准医药出海

2024-10-18

·BioSpace

Cerus Corporation Announces Workshop and Abstracts at the 2024 AABB Annual Meeting

Presentations Highlight the Unique Benefits of Real-world Utilization of INTERCEPT-treated Blood Products, Including INTERCEPT Fibrinogen Complex, and Recent Findings from the Phase 3 ReCePI Clinical Trial CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) today announced a selection of abstracts to be presented at the 2024 Association for the Advancement of Blood & Biotherapies (AABB) Annual Meeting, taking place in Houston, Texas from October 19 through October 22. This year’s AABB Annual Meeting attracts individuals and institutions from around the globe involved in the fields of transfusion medicine and biotherapies. The following is a select list of Cerus-related presentations and abstracts. All presentation times are listed in Central Daylight Time (CDT). Oral Presentations Sunday, October 20, 2024 – 9:30 a.m.– Acute Kidney Injury to Evaluate Amustaline/Glutathione Pathogen Reduced Red Cells in Cardiac Surgery: Outcomes of the ReCePI Phase III Clinical Trial (Speaker: E. Snyder) Monday, October 21 – 9:45 a.m. – Utilizing Sankey Diagrams to Quantify Laboratory Efficiency of INTERCEPT Fibrinogen Complex vs Traditional Cryoprecipitate (Speaker: D. Chen) Monday, October 21, 2024 – 2:00 p.m. – Phase IV Trial of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOPCLOT) in Cardiac Surgery (Speaker: M. Cushing) Monday, October 21, 2024 – 2:00 p.m. – HLA Alloimmunization in ReCePI, a Phase III Study of Amustaline/Glutathione Pathogen Reduced RBCs (Speaker: P. Norris) Monday, October 21, 2024 – 2:00 p.m. – Treatment-Emergent Antibodies to Amustaline/Glutathione Pathogen-Reduced Red Blood Cells in the ReCePI Phase III Clinical Trial (Speaker: R. Benjamin) Poster Presentations Held Sunday, October 20 and Monday, October 21, 2024 Evaluation of Pathogen Reduction Efficacy in Platelet Concentrates Until End of Shelf-Life with Two Different Automated Bacterial Detection Systems Development of a Next Generation Illuminator for Photochemical Inactivation of a Broad Spectrum of Pathogens in Platelet Concentrates Accelerating Treatment Delivery and Reducing Waste with Implementation of Pathogen Reduced Cryoprecipitated Fibrinogen Complex Wastage and Cost Analysis for INTERCEPT Fibrinogen Complex An Analysis of Anesthesiologist and Transfusion Service Staff Preferences Between Pathogen Reduced Cryoprecipitated Fibrinogen Complex and Conventional Cryoprecipitated AHF Analysis of Wastage, Savings, and Maternal and Pediatric Outcomes for Pooled Pathogen Reduced Cryoprecipitate versus Conventional Cryoprecipitate Pathogen Reduced Cryoprecipitate Implementation and Assessment of Its Impact in a Large Academic Medical Center Implementation of INTERCEPT Fibrinogen Complex (IFC) for Postpartum Hemorrhage Evaluation of INTERCEPT RBC Pathogen Reduction in Combination with Irradiation Industry Workshop Monday, October 21, 2024 – 7:00 a.m.– Industry Workshop Presented by Cerus: Pathogen Reduced Blood Components – Current Experiences and Future Developments with the INTERCEPT® Blood System (Speakers: J. Squires, C. Ingold, E. Snyder) The full program of Cerus-related abstracts can be found at the following link: Cerus representatives will be in the exhibition area at booth #431. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both C.E mark and FDA approval for these two blood components. In the U.S, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage clinical development. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Contacts Jessica Hanover Cerus Corporation 925-288-6137

临床3期

2024-10-17

·米内网

【获批】50亿大品种，首家过评定了

精彩内容 10月16日，丽珠集团发布公告称，控股子公司上海丽珠制药的注射用醋酸亮丙瑞林微球通过了一致性评价。亮丙瑞林是内分泌治疗用药TOP1品种，2023年在中国公立医疗机构终端的销售额超过50亿元，丽珠集团是该品种首家过评企业。表1：最新过评产品情况来源：公司公告、米内网整理据悉，注射用醋酸亮丙瑞林微球的适应症包括子宫内膜异位症；对伴有月经过多、下腹痛、腰痛及贫血等的子宫肌瘤，可使肌瘤缩小和/或症状改善；雌激素受体阳性的绝经前乳腺癌；前列腺癌；中枢性性早熟等。米内网数据显示，目前已上市的亮丙瑞林制剂包括了武田药品的注射用醋酸亮丙瑞林微球、丽珠集团的注射用醋酸亮丙瑞林微球、北京博恩特药业的注射用醋酸亮丙瑞林缓释微球，仅丽珠集团通过了一致性评价。图1：亮丙瑞林的销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端，亮丙瑞林的销售额在2022-2023年保持在50亿元水平，2024上半年止跌回升5.7%，潜力依然可期。目前，丽珠集团是亮丙瑞林的领军企业，2024上半年的市场份额为43.61%。公告中提到，丽珠集团针对注射用醋酸亮丙瑞林微球的一致性评价已累计投入的直接研发费用超过9000万元，本次通过一致性评价有利于进一步提升该药品的市场竞争力，巩固公司在国内微球制剂研发的优势地位。表2：丽珠集团目前已过评（含视同过评）的产品来源：米内网中国申报进度（MED）数据库目前，丽珠集团已过评（含视同过评）的产品有23个，其中苯磺酸氨氯地平胶囊、马来酸氟伏沙明片、盐酸哌罗匹隆片、注射用醋酸亮丙瑞林微球、注射用醋酸西曲瑞克、注射用丹曲林钠均为首家过评。资料来源：公司公告、米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至10月17日。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

一致性评价