ISRCTN35300716
Completed
Not Applicable
A comparative pharmacokinetic study of oral mifepristone and vaginal misoprostol in pregnant wome
World Health Organization (WHO) (Switzerland)0 sites60 target enrollmentMay 15, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- World Health Organization (WHO) (Switzerland)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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