Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 990
- 试验地点
- 2
- 主要终点
- Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)
研究概览
简要总结
This study will test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG.
详细描述
This is a comparative, pre-post study of the Non-pneumatic Anti-Shock Garment (NASG) to establish its effectiveness in reducing maternal mortality and morbidity due to obstetrical hemorrhage. The sites are two maternity teaching hospitals in Egypt: El Galaa, in Cairo and Assiut University in Assiut.
Our main aim was to test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG. Our primary outcome was Extreme Adverse Outcomes (EAO) - a combined outcome of maternal mortality and severe morbidity. Secondary outcomes included mean measured blood loss and incidence of emergency hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •blood loss from obstetric hemorrhage >= 1000 mL
- •pulse > 100 beats per minute or systolic blood pressure < 100 mmHg
排除标准
- •Absolute exclusion criteria:
- •current viable third trimester intrauterine pregnancy that can be delivered in the next 20 minutes after hemorrhage begins
- •current bleeding sites above the diaphragm.
- •Relative exclusion criteria:
- •history or current clinical evidence of mitral stenosis or congestive heart failure (CHF)
研究组 & 干预措施
Pre-Intervention
The Pre-Intervention Phase served as the Control / Baseline group.
Post-Intervention
Intervention used in this phase and outcomes compared to the Pre-Intervention phase.
干预措施: Non-pneumatic Anti-shock Garment (NASG) (Device)
结局指标
主要结局
Extreme Adverse Outcomes (EAO) - a Combined Outcome of Maternal Mortality or Severe Morbidity (Cardiac,Respiratory, Renal or Cerebral Dysfunction)
时间窗: from early pregnancy to within 3 weeks postpartum
次要结局
- Emergency Hysterectomy(within 72 hours of study enrollment)
- Blood Loss Due to Obstetric Hemorrhage(within 72 hours of study enrollment)