EUCTR2016-004726-42-GB进行中（未招募）1 期
Randomised controlled trial on the use of synthetic osmotic cervical dilator in induction of labour in comparison to dinoprostone vaginal insert - SOLVE
Birmingham Women's Hospital0 个研究点目标入组 860 人开始时间: 2016年12月15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
- 860
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
- •Women must meet the following criteria prior to initiation of IoL:
- •1.= 16 years of age
- •2.Able to provide informed consent
- •3.Singleton pregnancy
- •4.Indication for IoL
- •5.Pregnancy = 37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan at 11-14 weeks)
- •6.Living fetus with vertex presentation
- •7.Intact membranes
- •8.Bishop Score (NICE Modified version July 2008) < 6 points
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Women already receiving oxytocin
- •2.Diagnosis of fulminant preeclampsia / eclampsia
- •3.Contraindication to PROPESS or DILAPAN
- •4.If PROPESS for IoL is non-compliant with local policy
- •5.Enrolled in other randomised controlled trials of an IMP or device for cervical ripening or induction of labour
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