Non-pneumatic Anti-Shock Garment for Obstetrical Hemorrhage

非气动产科出血抗休克服

基本信息

批准号：
7663096
负责人：
SUELLEN MILLER
金额：
$ 41.29万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
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/7663096
关键词：
Accounting Acute 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 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 Teaching Hospitals Testing Time United States Universities Urine Woman Zambia Zimbabwe burden of illness design disability disability-adjusted life years experience group intervention improved mortality pilot trial primary outcome reproductive secondary outcome

项目摘要

DESCRIPTION (provided by applicant): 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, currently, 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 severe acute maternal morbidity, 3) reduce the incidence of emergency hysterectomies, and 4) reduce the time to recovery from hemorrhagic shock. The secondary aim is 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.

描述（由申请人提供）：孕产妇发病率和死亡率的全球疾病负担很大。怀孕和分娩相关疾病是生殖妇女，年龄在发展中国家的健康年龄损失的第二大主要原因，每年损失近3100万残疾人的生命年（达利人）。产妇死亡和残疾的最大贡献者是产科出血。由于延迟了获得最终疗法的延迟，例如输血或手术，因此在家中，初级保健中心和转诊医院的道路上流血致死。这项拟议的研究的目的是减少产科出血和低血容量减震器的严重病毒性，这是通过使用非毒性抗震动服装（NASG）的第一辅助剂。 NASG是可重复使用的氯丁橡胶和魔术贴下体压缩诉讼，在一些试点试验之外，在发展中国家中从未使用过。尽管已证明它可以逆转冲击并减少埃及的一项前/后试验后的产科患者的失血，但目前没有证据表明其使用会降低孕产妇死亡或发病率。在一个循证实践的时代，未经国际捐助者和卫生专家的批准，低资源环境中的产妇医疗系统无法采用新程序。这项研究的主要目的是证明，使用聚类随机的受控设计，在转移到转诊医院之前，NASG在初级卫生保健水平上的应用将降低极端不良后果，即产妇死亡率和严重的母体发病率。该项目的主要目的是测试NASG作为急救出血和冲击管理的有效性）1）1）降低孕产妇死亡率的发生率，2）降低严重急性孕妇发病率的发生率，3）减少紧急子宫颈切除术的发生率，4）减少从出血休克中恢复的时间。第二个目的是检查可能与NASG使用有关的负面影响，包括1）尿量降低，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）女性在接受NASG的女性中的恶心和呕吐。