Mifepristone and Misoprostol for the termination of pregnancies of 10-20 wks (64-140 days) gestation/in Thailand of 10-14 weeks (64-104 days) gestation

Concept foundation0 个研究点目标入组 670 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•good general health
•-older than the age of legal consent,if her age is younger than age of legal consent,parent should sign informed consent together with volunteer. There is no upper limit and study sites may have different minimum age limits.
•-requesting abortion and eligible for legal termination of pregnancy
•-on Day 1 of the study (day of mifepristone administration) the duration of pregnancy between 64-140 days, - 64-104 days LMP in Thailand - verified by ultrasound
•-the pregnancy is single and intrauterine (single sac)
•-if treatment with the proposed regimen should fail agrees to be treated with the method used at the clinic routinely in this kind of cases
•-willing and able to participate after the study has been explained
•-haemoglobin higher than 90 g/l.
•Volunteers live within reasonable distance from hospital premises.

•allergy towards mifepristone or misoprostol
•- 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) or prostaglandins (mitral stenosis, sickle cell anaemia, uncontrolled hypertension, systolic blood pressure lower than 90 mmHg 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
•- the presence of an IUD in utero
•-previous surgery of uterus/uterine cervix is a relative contraindication. However, one previous low-segment caesarean section does not need to be a contra-indication
•-molar pregnancy or threatened abortion
•-in case difficulties are anticipated in the follow-up of the woman.
•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 factors for cardiovascular disease.
•Women who breastfeed can be included but they may discard the breast milk on the day of mifepristone administration.

发起方

Concept foundation