Novel Vacuum-Induced Postpartum Hemorrhage Control: a Multicenter Randomized Trial.

新型真空诱导产后出血控制：多中心随机试验。

• 批准号: 10673043
• 负责人: Methodius Gamuo Tuuli
• 金额: $ 47.76万
• 依托单位: WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673043
• 关键词: Accounting; Adverse event; Balloon Dilatation; Beds; Blood Vessels; Case Series; Catheters; Childbirth; Clinical Trials; Contracts; Control Groups; Data; Devices; Discipline of obstetrics; Effectiveness; Endometritis; Enrollment; Event-Related Potentials; Ghana; Health; Hemorrhage; Hemostatic function; Hour; Hypovolemia; Hypovolemics; Hysterectomy; Incidence; Indonesia; Injury; Ligation; Massage; Maternal Mortality; Measures; Mechanics; Medical; Operative Surgical Procedures; Outcome Study; Physiological; Physiology; Postpartum Hemorrhage; Postpartum Period; Preventive measure; Public Health; Randomized, Controlled Trials; Research; Research Personnel; Route; Safety; Sample Size; Selection Bias; Surgical sutures; Symptoms; System; Testing; Therapeutic; Third Stage Labor; Time; Traction; United States; Urinary tract; Uterine Contraction; Uterine Inertia; Uterine Perforation; Uterine Rupture; Uterine hemorrhage; Uterus; Vacuum; Woman; arm; condoms; constriction; cost; cost effective; cost effectiveness; cost estimate; cost per quality-adjusted life year; design; effectiveness evaluation; experience; global health; improved; incremental cost; low and middle-income countries; maternal morbidity; maternal outcome; multidisciplinary; novel; pressure; prophylactic; randomized trial; relative effectiveness; reproductive tract; safety assessment; standard care

ABSTRACT Every year, 130 million women deliver babies around the world, and an estimated 14 million experience postpartum hemorrhage (PPH) − recently redefined as a cumulative blood loss of 1000 ml or more or blood loss associated with signs or symptoms of hypovolemia, irrespective of the route of delivery. PPH is the leading cause of maternal mortality worldwide, responsible for 25% of maternal deaths from obstetric causes, with 99% occurring in low and lower-middle income countries (LMICs). The most common cause of PPH is uterine atony − when the uterus fails to adequately contract after childbirth − accounting for 70% of all PPH. Active management of the third stage of labor, consisting of administering prophylactic uterotonics, controlled cord traction, and uterine massage, reduces the incidence of PPH by approximately 66%. When PPH occurs in spite of these preventive measures, therapeutic options include additional uterotonics (medical), uterine tamponade (mechanical) and surgical interventions (vascular ligation, uterine compression sutures and hysterectomy). Uterine balloon tamponade is often the second line therapy when medical management is unsuccessful and is achieved with inflatable devices inserted into the uterus to exert outward compression on the uterine walls. Despite its widespread use, its mechanism is counterintuitive to the physiologic uterine contraction that occurs after delivery to control bleeding. Its use is further limited by prolonged treatment times (typically 12-24 hours), urinary tract occlusion, and inability to reveal any continuing bleeding. Low-cost options − most commonly condom catheters − are used in LMICs, but two recent randomized trials showed no improvement in maternal outcomes and possible harm. Thus, there is an urgent need for effective and safe treatment options to reduce the burden of PPH particularly in LMICs. The Jada® System is a novel FDA-cleared intrauterine vacuum-induced hemorrhage-control device specifically designed for rapid treatment of PPH. It mimics postpartum physiology by applying low-level intrauterine negative pressure to facilitate uterine compressive forces for constriction of blood vessels to achieve hemostasis. Preliminary data from two studies have shown promising results, but these data are limited by lack of control groups, possible selection bias and the modest sample sizes which preclude definitive conclusions regarding the relative effectiveness and safety of the Jada® System. We propose the first definitive, randomized control trial to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care. A multidisciplinary team of investigators with expertise in obstetrics, global health and clinical trials will enroll 424 women in two high volume obstetric units in Ghana, a LMIC with high PPH burden, to evaluate the effectiveness (Primary Aim), 2) safety (Secondary Aim 1), and 3) cost-effectiveness (Secondary Aim 2) of the Jada® System, compared to standard care, in treating PPH.

摘要 每年，全世界有1.3亿妇女分娩， 产后出血（PPH）-最近重新定义为累积失血1000 ml或更多或失血 与低血容量症的体征或症状相关，无论分娩途径如何。PPH是领先的 全球孕产妇死亡原因中，25%的孕产妇死于产科原因，99%的孕产妇死于产科原因。 低收入和中低收入国家（LMIC）。PPH最常见的原因是子宫收缩乏力 - 分娩后子宫不能充分收缩-占所有PPH的70%。活性 第三产程的管理，包括给予预防性子宫收缩剂，控制脐带 牵引和子宫按摩可使PPH的发生率降低约66%。当PPH发生时， 在这些预防措施中，治疗选择包括额外的子宫收缩剂（药物），子宫填塞， （机械）和手术干预（血管结扎、子宫压迫缝合和子宫切除术）。 当医疗管理不成功时，子宫球囊填塞通常是二线治疗， 通过插入子宫的可膨胀装置对子宫施加向外的压力来实现 墙尽管它被广泛使用，但它的机制与生理性子宫收缩相反， 分娩后发生，以控制出血。其使用还受到延长的治疗时间（通常12-24 小时），尿路阻塞，无法显示任何持续出血。低成本选项-最常见的 避孕套导管-在LMIC中使用，但最近的两项随机试验显示， 结果和可能的伤害。因此，迫切需要有效和安全的治疗方案，以减少 PPH的负担，特别是在中低收入国家。 Jada®系统是一种经FDA批准的新型宫内真空诱导节育器， 用于PPH的快速治疗。它通过应用低水平的子宫内阴性来模仿产后生理学 压力，以促进子宫压缩力收缩血管，实现止血。 两项研究的初步数据显示了有希望的结果，但这些数据因缺乏控制而受到限制 组，可能的选择偏倚和适度的样本量，这些因素排除了关于 Jada®系统的相对有效性和安全性。我们提出了第一个明确的随机对照 一项旨在检验Jada®系统治疗PPH有效、安全且具有成本效益的假设的试验， 标准护理一个多学科的研究团队，拥有产科，全球健康和临床 试验将在加纳的两个高容量产科单位招募424名妇女，这是一个具有高PPH负担的LMIC，以评估 有效性（主要目标），2）安全性（次要目标1）和3）成本效益（次要目标2） 与标准治疗相比，Jada®系统在治疗PPH方面的优势。