EUCTR2017-004083-35-FR进行中（未招募）1 期
A double-blind, randomized, multicenter study evaluating 200 mg versus 600 mg of Mifepristone on pain in voluntary abortion by drug prior to 7 SA. DoMy Study - DoMy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1
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
- •Female aged 18 or over.
- •Female with a single intrauterine pregnancy, the term of which is less than 7 weeks on the day of mifegyne intake, estimated by ultrasound with a cranio-caudal length measurement less than or equal to 10 millimeters.
- •Woman seeking medical abortion in hospital.
- •A woman who has signed a written informed consent and agrees to abide by the protocol.
- •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 320
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Minor woman.
- •Female with multiple pregnancy, uterine malformation (cloisonné uterus, bicorn, fibroma) or coagulation disorder defined by biological parameters (TP <70%, TCA patient / control ratio <1.20).
- •Female with a contraindication to mifepristone: chronic adrenal insufficiency, severe asthma not controlled by treatment, hereditary porphyria, known allergy to the active substance or to any of the excipients.
- •Women with a contraindication to misoprostol: hypersensitivity to the active substance, to any of the excipients or to other prostaglandins;
- •Female with contraindication to one of the analgesics used in the study (nefopam, paracetamol, opium, caffeine).
- •Female not affiliated to the social security system.
- •Wife with no informed consent.
研究者
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