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临床试验/EUCTR2009-010277-21-GB
EUCTR2009-010277-21-GB进行中(未招募)不适用

A Randomised Controlled Trial on Efficacy of mifepristone followed by 6-8 hours versus 24 hours vaginal misoprostol in Early Pregnancy Abortions (< 63 days gestations) - TIMES study

Calthorpe Clinic0 个研究点开始时间: 2009年4月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • 1.Women over the age of 18 years and eligible for legal termination of pregnancy
  • 2.Request for medical abortion
  • 3.Duration of pregnancy not more than 63 days (counted from the first day of the last menstrual period) in a normal 28-day cycle
  • 4.If treatment with misoprostol should fail, agrees to surgical termination of pregnancy and repeat medical methods
  • 5.Willing and consent to participate after the study has been explained
  • 6.Haemoglobin higher than 8.0g/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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Any indication of serious past or present ill health will be considered contraindication for recruitment to the study
  • 2.In conditions where medical abortion is considered a risk than benefits as in
  • a.Allergy towards mifepristone or misoprostol
  • b.Medical 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 mmHg, systolic blood pressure lower than 90 mmHg measured with a traditional instrument)
  • 3.The presence of an Intrauterine Device (IUD) in utero
  • 4.Breastfeeding
  • 5. Previous surgery of uterus/uterine cervix is a relative contraindication. However, previous lower segment caesarean section does not need to be a contraindication.
  • 6.Suspicion of any pathology of pregnancy (e.g. molar, non-viable pregnancy, threatened abortion)

研究者

发起方
Calthorpe Clinic

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