EUCTR2017-002694-19-NL进行中（未招募）1 期
Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (M&M trial). - Triple M trial
Radboud University Medical Centre0 个研究点目标入组 460 人开始时间: 2018年2月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Early pregnancy failure, 6-14 weeks postmenstrual with
- •-a crown-rump length = 6mm and no cardiac activity OR
- •-a crown-rump length <6mm and no fetal growth at least one week later OR
- •-a gestational sac with absent embryonic pole for at least one week.
- •At least one week after diagnosis OR a discrepancy of at least one week between crownrump length and calendar gestational age
- •Intrauterine pregnancy
- •Women aged above 18 years
- •Hemodynamic stable patient
- •No signs of infection
- •No signs of incomplete abortion
- •No contraindications for mifepristone or misoprostol
- •No high risk of thrombosis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 464
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient does not meet inclusion criteria, discovered after randomization.
- •Inability to give informed consent.
- •Interaction between study-medication and other medicine.
- •Contra-indications for the use of Mifepristone and/or Misoprostol.
- •Language barrier
研究者
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