A comparative pharmacokinetic study of oral mifepristone and vaginal misoprostol in pregnant wome

World Health Organization (WHO) (Switzerland)0 个研究点目标入组 60 人开始时间: 2008年5月15日最近更新: 2015年1月13日

适应症

试验速览

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•Subjects admitted to the study will fulfil the following criteria:
•1. Good general health
•2. Older than the legal age of consent
•3. On day one of the study (day of mifepristone administration) the duration of pregnancy is not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle
•4. The duration of the pregnancy corresponds to the length of amenorrhoea when verified by ultrasound; if the gestational length according to ultrasound measurements differ by more than four days, the ultrasound dating will be used
•5. The pregnancy is single and intrauterine (single sac)
•6. If treatment with misoprostol should fail, subject agrees to surgical termination of pregnancy
•7. Willing and able to participate in the study once the objective and study requirements have been explained

•Subjects will not be recruited if any of the following conditions are present:
•1. Allergy towards mifepristone or misoprostol
•2. A history or evidence of disorders that represent a contraindication to the use of mifepristone (chronic adrenal failure, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria)
•3. A history or evidence of disorders that represent a contraindication to the use of prostaglandins (mitral stenosis, glaucoma, sickle cell anaemia, diastolic pressure over 90 mmHg, bronchial asthma, arterial hypotension)
•4. A history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy
•5. Has any medical condition or disease that requires regular treatment with systemic drugs, care or precaution in conjunction with abortion
•6. Tendency of abnormal bleeding (such as von Willebrandt's disease)
•7. The presence of intrauterine device (IUD) in utero
•8. Previous surgery of uterus/uterine cervix is a relative contraindication, however, previous low-segment caesarean section is not a contraindication
•9. Suspicion of any pathology of pregnancy (e.g., molar, non-viable pregnancy, threatened abortion)
•10. Suspected or known breast or genital neoplasia
•11. Breast-feeding
•12. Where difficulties are anticipated in follow-up

发起方

World Health Organization (WHO) (Switzerland)