Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Duration of hospitalization
研究概览
简要总结
The purpose of this study is to determine the efficacy of dexamethasone for treatment of HELLP I (hemolysis, elevated liver enzymes and low platelet count) syndrome.
详细描述
Treatment of HELLP syndrome usually is restricted to measures of support and treatment of complications. In 2005, in a subgroup analysis we showed that, among patients with HELLP 1, there were a shorter average time to platelet recovery and less duration of hospitalization in women who received dexamethasone therapy, however the importance of this finding is diminished because this was an unplanned analysis and the severity of the disease was not taken into account at randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 48 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who were at >20 weeks of gestation or during the first 3 days of puerperium if hypertension developed during the pregnancy or the puerperium with:
- •platelet count, < or = 50,000/mm3; aspartate aminotransferase (AST), > or = 70 U/L; lactate dehydrogenase (LDH), > or = 600 U/L.
- •Women who consent to be included informed consent by signature
排除标准
- •diabetic ketoacidosis
- •oral temperature > 37.5 grade
- •Contraindication for use steroids
研究组 & 干预措施
sterile water
Pregnant women will receive 2.5 cc of sterile water every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 doses after delivery.
干预措施: sterile water (Drug)
Dexamethasone
Pregnant women in the experimental group will receive 10-mg doses (2.5 cc) of dexamethasone sodium phosphate intravenously every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 10-mg doses after delivery.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Duration of hospitalization
时间窗: Average: 15 days
次要结局
- Recovery time of platelets to more than 100000/mm3(Average:7 days)
- Recovery of AST, ALT and LDH(Average: 10 days)
- Transfusion of blood products(Average: 7 days)