EUCTR2007-007950-77-GB进行中（未招募）1 期
Does progesterone prophylaxis to prevent preterm labour improve outcome? - a randomised double blind placebo controlled trial (OPPTIMUM) - OPPTIMUM
niversity of Edinburgh and NHS Lothian Health Board0 个研究点目标入组 1,228 人开始时间: 2008年2月8日最近更新:
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
- 1,228
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
- •High risk for PTB as indicated by: at least one of (i) history of previous PTB/ second trimester loss (ii) previous preterm premature rupture of the fetal membranes (iii) short cervical length (< 25mm) on ultrasound at 18 – 22 weeks gestation. Additionally all will have a positive fFN at 22weeks. All women will have gestation established by scan at =16 weeks.
- •Are the trial subjects under 18? yes
- •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
- •Known significant structural or chromosomal fetal anomaly; known sensitivity, contraindication or intolerance to progesterone; suspected or proven rupture of the fetal membranes at the time of recruitment; multiple pregnancy; prescription or ingestion of medications known to interact with progesterone (eg ketoconazole and ciclosporin).
研究者
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