ISRCTN24130607已完成未知
Comparison of two mifepristone doses and two misoprostol intervals for early pregnancy termination
DP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction0 个研究点目标入组 2,181 人开始时间: 2004年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 2,181
研究概览
简要总结
2009 Results article in https://doi.org/10.1111/j.1471-0528.2008.02034.x (added 27/10/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy women
- •2. Eligible for and requesting medical abortion
- •3. Agrees to surgical termination should method fail
排除标准
- •Any indication of past or present ill health will be considered a contraindication for recruitment to the study. In particular, subjects should 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:
- •2.1. Mifepristone (chronic adrenal failure, known allergy to mifepristone, severe asthma uncontrolled by corticosteroid therapy, inherited porphyria)
- •2.2. Prostaglandins (mitral stenosis, glaucoma, sickle cell anaemia, diastolic pressure over 90 mmHg, bronchial asthma, systolic blood pressure lower than 90 mmHg)
- •3. A history or evidence of thrombo-embolism, severe or recurrent liver disease
- •4. Has a medical condition or disease that requires special treatment, care or precuation (e.g. corticosteroid or anticoagulant therapy) in conjunction with abortion
- •5. Uterine fibroids are relative contraindication (women with fibroids that are likely to affect bleeding or contractility should be excluded)
- •6. The presence of an Intra-Uterine Device (IUD) in utero (if IUD can easily be removed from the uterus before administration of mifepristone, subject can be included) breast-feeding
- •previous surgery of uterus/uterine cervix is a relative contraindication
- •In addition, a woman should not be recruited for the study if she is:
- •7. A heavy smoker (i.e. smoking more than 20 cigarettes daily) or has another risk factor for cardiovascular disease
研究者
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