Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 342
- 试验地点
- 13
- 主要终点
- Complete evacuation
研究概览
简要总结
This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.
It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.
详细描述
This study will test the hypothesis that, in early pregnancy failure, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation of products of conception (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). The trial will be performed multi-centred (hospitals), prospectively, two-armed, randomized, double-blinded and placebo-controlled.
Women with ultrasonographically confirmed early pregnancy failure (6-14 weeks postmenstrual), managed expectantly for at least one week, can be included. Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance). The investigators aim to randomize 460 women in a 1:1 ratio, stratified by centre.
After six weeks, the primary endpoint, complete or incomplete evacuation, will be determined
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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 crown-rump length and calendar gestational age
- •Intra-uterine 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
- •Known clotting disorder or use of anticoagulants
- •Known risk factors for, or presence of, a cardiovascular disease
- •Language barrier
研究组 & 干预措施
Misoprostol
Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive an oral placebo.
干预措施: Misoprostol (Drug)
Misoprostol and Mifepristone
Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive oral mifepristone (600mg).
干预措施: Mifepristone (Drug)
Misoprostol and Mifepristone
Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive oral mifepristone (600mg).
干预措施: Misoprostol (Drug)
结局指标
主要结局
Complete evacuation
时间窗: six weeks after initial treatment
Whether or not complete evacuation (total endometrial thickness \<15 mm) has been acquired will be assessed through ultrasonography.
次要结局
- Overall quality of health, as experienced by the patient.(At baseline, day four, and two and six weeks after initial treatment.)
- patient satisfaction(At baseline, day four, two and six weeks after treatment)
- costs(up to six weeks after treatment)
- side effects(six weeks after treatment)
- complications(six weeks after treatment)