NL-OMON48955已完成4 期
Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (Triple M trial) - Triple M trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 352
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 16 years
- •Hemodynamic stable patient
- •No signs of infection
- •No signs of incomplete abortion
- •No contraindications for mifepristone or misoprostol
排除标准
- •Patient does not meet inclusion criteria, discovered after randomization.
- •Inability to give informed consent.
- •Contra-indication for the use of Mifepristone or Misoprostol.
- •Interaction between study-medication and other medicine.
- •Language barrier.
- •Known clotting disorder or use of anticoagulants
- •Known risk factors for, or presence of, a cardiovascular disease
研究者
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