NCT00442676撤回2 期
Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Length from start of treatment to delivery
研究概览
简要总结
Preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and maternal morbidity and mortality. Recent findings indicate preeclampsia is an inflammatory disorder associated with increased expression of COX-2. This study will test the hypothesis that treatment of women with a COX-2 inhibitor, celecoxib, will stop the inflammatory process and reverse symptoms of preeclampsia.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with preeclampsia between 20 - 32 weeks gestation. Preeclampsia is defined as a maternal blood pressure of >140/90 mmHg on two readings at least 6 hours apart with proteinuria of >300 mg/24 hours.
排除标准
- •Exclusion criteria includes patients with known sensitivity to celecoxib; patients who have demonstrated allergic-type reactions to sulfonamides; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Other exclusion criteria will include patients with known cardiovascular disease or risk factors for cardiovascular disease, a prior history of ulcer disease or GI bleeding, impaired renal function, or liver dysfunction. Exclusion criteria will also include concomitant use of oral corticosteroids, anticoagulants, diuretics, ACE inhibitors, aspirin, fluconazole, and lithium.
研究组 & 干预措施
1
Experimental
Celecoxib, 200 mg/day
干预措施: Celecoxib (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Length from start of treatment to delivery
时间窗: From start of treatment to delivery
次要结局
- Prevalence of severe preeclampsia(From start of treatment to delivery)
- Blood pressure(From start of treatment to delivery)
- Proteinuria(From start of treatment to delivery)
- Maternal complications(From start of treatment to delivery)
- Fetal/neonatal status(From start of treatment to delivery)
- Gestational age at delivery(At time of delivery)
- Birth weight(At time of delivery)
研究者
研究点 (1)
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