NCT00190294已完成4 期
Comparison Expectant With Immediate Medical Management for the Evacuation of the no Evolutionary Pregnancies Before 13 GW
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of surgical evacuation in each group
研究概览
简要总结
Compared the interest of one week expectancy vs immediate medical treatment in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.
详细描述
Randomized control trial comparing one week expectancy vs immediate medical treatment (mifepristone 200mg and misoprostol 400ug) in the taking care of the evacuation of the no evolutionary pregnancies before 13 GW.
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
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Agreed women aged over 18 yrs old
- •Non evolutive pregnancy before 13GW :
- •Non evolutive pregnancy with no fetal cardiac activity
- •Non evolutive pregnancy with embryonic structures
- •Trophoblastic material in uterine cavity P bhCG < 10UI/L
- •Exclusion criteria:
- •Age < 18 years
- •pregnancy evolutionary
- •not evolutionary pregnancy after 13 weeks of amenorrhoea characterized by the presence of an scan image intra-uterine ANECHOGENE furthermore of 50mm of diameter
- •amenorrhoea of more than 13 weeks
- •pregnancy twin
- •pregnancy molar
- •pregnancy extra-uterine
- •Extra-uterine pregnancy
- •one or many contraindications in the mifepristone:
- •Allergy known about the MIFEPRISTONE
- •Incapacity suprarenal
- •corticosteroid therapy in the long price
- •confusions of the haemostasis (thrombopenia < in 100000 / mm3)
- •anaemia (rate Hg < in 9 g / dl)
- •contraindication in the misoprostol
- •allergy known about PROSTAGLANDINES
- •BEANCE cervical
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
MIFEPRISTONE 200 mg and misoprostol 400 µg
干预措施: MIFEPRISTONE 200 mg and misoprostol 400 µg (Drug)
结局指标
主要结局
Number of surgical evacuation in each group
时间窗: during de study
Number of surgical evacuation in each group
次要结局
未报告次要终点
研究者
研究点 (1)
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