Non-pneumatic Anti-Shock Garment for Obstetrical Hemorrhage

描述（由申请人提供）：孕产妇发病率和死亡率造成的全球疾病负担很大。妊娠和分娩相关疾病是发展中国家育龄妇女健康生命年损失的第二大原因，每年导致近 3100 万伤残调整生命年 (DALYS) 损失。造成孕产妇死亡和残疾的最大因素是产科出血。由于长时间延迟获得输血或手术等明确治疗，妇女在家中、初级保健中心和前往转诊医院的途中因失血过多而死亡。这项拟议研究的目标是通过非气动抗休克服（NASG）的急救应用来降低孕产妇死亡率以及产科出血和低血容量休克引起的严重发病率。 NASG 是一款可重复使用的氯丁橡胶和尼龙搭扣下半身压缩服，除了几次试点试验外，从未在发展中国家使用过。尽管埃及的一项前期/后期试点研究表明，它可以逆转休克并减少产科患者的失血量，但目前没有证据表明它的使用会降低孕产妇死亡率或发病率。在循证实践时代，资源匮乏地区的孕产妇保健系统在未经国际捐助者和卫生专家批准的情况下无法采用新程序。本研究的主要目的是通过整群随机对照设计证明，在转入转诊医院之前在初级卫生保健层面应用 NASG 将减少极端不良后果，即孕产妇死亡率和严重孕产妇发病率。该项目的主要目的是测试 NASG 作为急救出血和休克管理的有效性，以：1) 降低孕产妇死亡率，2) 降低严重急性孕产妇发病率，3) 降低紧急子宫切除术的发生率，4) 缩短从失血性休克中恢复的时间。第二个目的是检查可能与 NASG 使用相关的负面影响，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) 接受 NASG 的女性出现恶心和呕吐。

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.