EUCTR2006-002596-40-SE进行中（未招募）不适用
Comparison of two doses and two routes of administration of misoprostol after pre-treatment with mifepristone for early pregnancy termination: a randomized, placebo-controlled, multicentre trial - Two doses and two routes of misoprostol
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,008
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
- •- good general health
- •- older than the age of legal consent
- •- requesting abortion and eligible for legal termination of pregnancy
- •- on Day 1 of the study (day of mifepristone administration) the duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle
- •- the duration of the pregnancy corresponds to the length of amenorrhoea when verified with ultrasound, if the gestational length according to ultrasound measurements differ more than 4 days, the ultrasound dating should be used
- •- the pregnancy is single and intrauterine (single sac)
- •- if treatment with misoprostol should fail agrees to surgical termination of pregnancy
- •- willing and able to participate (return to follow-up) after the study has been explained
- •- haemoglobin higher than 90 g/l.
- •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
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any indication of serious past or present ill health will be considered a contraindication for recruitment to the study.
- •In particular:
- •- allergy towards mifepristone or misoprostol
- •- a history or evidence of disorders that represent a contraindication to the use of mifepristone (chronic adrenal failure, known allergy to mifepristone, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria) or prostaglandins (mitral stenosis, sickle cell anaemia, diastolic pressure over 90 mm Hg, systolic blood pressure lower than 90 mm Hg measured with a traditional instrument)
- •- a history or evidence of thrombo-embolism, severe or recurrent liver disease
- •- has a medical condition or disease that requires special treatment, care or precaution (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion
- •- uterine fibroids are relative contraindications (women with fibroids that are likely to affect bleeding or contractility should be excluded)
- •- the presence of an IUD in utero
- •- breastfeeding
- •- previous surgery of uterus/uterine cervix is a relative contraindication. However, previous low-segment caesarean section does not need to be a contra-indication
- •- suspicion of any pathology of pregnancy (e.g. mola, non-viable pregnancy, threatened abortion)
- •- in case difficulties are anticipated in the follow-up of the woman (e.g. lives too far).
- •Women older than 35 years can be recruited for the present trial provided they do not smoke, their diastolic blood pressure is <90mmHg and have no known risk facgtor for cardiovascular disease.
研究者
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