Non-pneumatic Anti-Shock Garment for Obstetrical Hemorrhage

非气动产科出血抗休克服

• 批准号: 7491914
• 负责人: SUELLEN MILLER
• 金额: $ 5.08万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7491914
• 关键词: Accounting; Address; Adopted; Adverse effects; Age; Blood Transfusion; California; Caring; Case Series; Cessation of life; Childbirth; Control Groups; Developed Countries; Developing Countries; Devices; Discipline of obstetrics; Dyspnea; Effectiveness; Egypt; Emergency Medical Technicians; Emergency Situation; Evidence based practice; Experimental Designs; First Aid; Goals; Health; Health care facility; Healthcare Systems; Hemorrhage; Hemorrhagic Shock; Home environment; Hospital Referrals; Hospitals; Hour; Hypovolemic Shock; Hypoxia; Hysterectomy; Incidence; International; Intervention; Life; Maternal Health; Maternal Mortality; Morbidity - disease rate; Nausea and Vomiting; Neoprene; Operative Surgical Procedures; Outcome; Output; Patients; Pilot Projects; Postpartum Hemorrhage; Pregnancy; Primary Health Care; Procedures; Randomized; Recovery; Research; Research Design; Resources; Respiratory distress; Resuscitation; San Francisco; Satellite Hospitals; Shock; Statistically Significant; Teaching Hospitals; Testing; Time; United States; Universities; Urine; Woman; Zambia; Zimbabwe; burden of illness; design; disability; disability-adjusted life years; experience; improved; mortality; pilot trial; reproductive

The global burden of disease from maternal morbidity and mortality is great. Pregnancy and childbirth related illnesses are the second leading cause of lost years of healthy life among women of reproductive,age in developing countries, accounting for nearly 31 million disability adjusted life years (DALYS) lost annually. The largest contributor to maternal death and disability is obstetric hemorrhage. Due to long delays in obtaining definitive therapy, such as blood transfusion or surgery, women bleed to death at home, in primary health care centers, and on the road to referral hospitals. The goal of this proposed study is to reduce maternal mortality and severe morbidities from obstetric hemorrhage and hypovolemic shock by the first-aid application of the non-pneumatic anti-shock garment (NASG). The NASG is a reusable neoprene and Velcro lower-body compression suit, which has, outside of a few pilot trials, never been used in the developing world. Although it has been shown to reverse shock and to decrease blood loss in obstetric patients in one pre/post pilot study in Egypt, there is, currnelty, no evidence that its use will decrease maternal mortality or morbidity. In an era of evidence-based practice, maternity health care systems in low resource settings cannot adopt new procedures without approval of international donors and health experts. The primary aim of this study is to demonstrate, using a cluster-randomized controlled design, that application of the NASG at the primary health care level before transfer to a referral hospital will decrease extreme adverse outcomes, i.e.,maternal mortality and severe maternal morbidity. The primary aim of this project is to test the effectiveness of the NASG as first aid hemorrhage and shock management to) 1) reduce the incidence of maternal mortality, 2) reduce the incidence of severeacute maternal morbidity, 3) reduce the incidence of emergency hysterectomies, and 4) reduce the time to recovery from hemorrhagic shock. The secondary aim is to to examine negative effects that might be associated with NASG use, including 1) decreased urine output, 2) hypoxia, dyspnea, or other forms of respiratory distress, 3) increased intraoperative bleeding, and/or 4) nausea and vomiting in the women who receive the NASG.

孕产妇发病率和死亡率造成的全球疾病负担很大。怀孕和分娩 相关疾病是育龄妇女健康寿命损失的第二大原因， 在发展中国家，每年损失近3100万残疾调整生命年（DAPIs）。 造成产妇死亡和残疾的最大原因是产科出血。由于长期拖延， 获得明确的治疗，如输血或手术，妇女出血死亡在家里，在主要 卫生保健中心，并在路上转诊医院。这项研究的目的是减少 产妇死亡率和产科出血和低血容量性休克的严重发病率 非充气式抗休克服（NASG）的应用。NASG是一种可重复使用的氯丁橡胶， 维可牢尼龙搭扣下半身压缩服，除了一些试点试验外，从未在 发展中国家的团结合作虽然它已被证明可以逆转休克和减少产科失血， 在埃及进行的一项试点研究的前/后患者中，目前没有证据表明其使用会减少 产妇死亡率或发病率。在一个以证据为基础的实践时代，产妇保健系统在低 未经国际捐助者和卫生专家批准，资源环境不能采用新程序。 本研究的主要目的是使用随机分组对照设计证明， 在转移到转诊医院之前，在初级卫生保健水平上申请NASG的情况将减少 极端不良后果，即，产妇死亡率和严重产妇发病率。 本项目的主要目的是测试NASG作为急救出血和休克的有效性 （1）降低孕产妇死亡率，（2）降低孕产妇死亡率， 产妇发病率，3）减少急诊子宫切除术的发生率，4）减少 从失血性休克中恢复过来第二个目的是检查可能产生的负面影响， 与NASG使用相关，包括1）尿量减少，2）缺氧，呼吸困难，或其他形式的 呼吸窘迫，3）术中出血增加，和/或4）恶心和呕吐， 接收NASG。