Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- severe maternal morbidity
研究概览
简要总结
Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome. The benefit of faster and better recovery would be observed in fewer complications, less utilization of blood products and shorter hospital stay.
详细描述
Patients with Class I HELLP Syndrome will be recruited for use os dexamethasone or placebo in the puerperium. Effects such as clinical course (blood pressure and diureses), laboratorial behaviour and complications will be compared. Duration of hospitalization will also be accessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum women with Class I HELLP syndrome
排除标准
- •Chronic users of corticosteroids
- •Patients with chronic conditions affecting the laboratory parameters involved in the HELLP syndrome
- •Women who had received antenatal corticosteroids to treat HELLP syndrome were excluded
研究组 & 干预措施
saline solution
Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
干预措施: dexamethasone (Drug)
saline solution
Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
干预措施: Placebo (Drug)
Dexamethasone
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
干预措施: dexamethasone (Drug)
结局指标
主要结局
severe maternal morbidity
时间窗: postpartum
42 days after delivery
次要结局
- hospital stay duration(postpartum)
研究者
Leila Katz
Obstetrical ICU obstetrical coordinator; MD , PhD
Instituto Materno Infantil Prof. Fernando Figueira