EUCTR2013-002561-19-AT进行中（未招募）1 期
A prospective, double blind, randomised, placebo controlled trial to evaluate the effect of a long term tokolysis with atosiban on the pregnancy outcome. A pilot study. - Long term tokolysis with atosiban
Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Geburtshilfe und Feto-maternale Medizin0 个研究点目标入组 60 人开始时间: 2014年1月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •intact singleton pregnancy between 23+0 and 28+0 weeks gestation
- •intact membranes
- •cervical length = 15mm
- •immediate previous completion of standard tocolysis with atosiban for 48 hours
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study
- •Signed the written informed consent
- •women over 18 years
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •rupture of membranes
- •Amnion infection syndrome, fever (>38°C)
- •vaginal bleeding with intensity of menstruation or above
- •placenta praevia
- •polyhydramnion
- •congenital malformations, deformations and chromosomal abnormalities
- •preexistant Diabetes Typ I or II
- •multiple pregnancies
- •Prolaps of membranes till the external cervical os.
研究者
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