EUCTR2015-002942-30-NL进行中(未招募)1 期
Continued versus discontinued oxytocin stimulation of labour in a doubleblind randomised controlled trial.
Regional Hospital of Randers0 个研究点目标入组 1,200 人开始时间: 2017年12月18日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,200
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 stimulated with Syntocinon® infusion for induction of labour
- •(with or without cervical priming by prostaglandin) or for augmentation
- •of slow labour in the latent phase (regular contractions for at least four
- •hours and a cervical dilatation of = 4cm).
- •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 1200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •<18 years and >45 years
- •Unable to read and understand the Danish language or to give informed consent
- •Cervical dilatation > 4 cm
- •Non-cephalic presentation
- •Multiple gestation
- •Pathological fetal heart rate pattern (cardiotocogram, CTG) before
- •Syntocinon® initiation
- •Fetal weight estimation > 4500 g (clinical or ultrasonic)
- •Subject declines participation
- •Gestational age less than 37 completed weeks
研究者
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CONDISOX: Continued versus discontinued oxytocin stimulation of labour in a double-blind randomised controlled trial.Syntocinon is used for labour induction to stimulate contractions. The current recommendation is to stimulate until delivery. We hypothesize that discontinuation of Syntocinon when the active phase of labour is established will reduce risk of harm of both mother and child and labour will progress.MedDRA version: 20.0Level: LLTClassification code 10062462Term: Labor stimulationSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10023540Term: Labor inducedSystem Organ Class: 100000004868EUCTR2015-002942-30-DKRegional Hospital of Randers1,700
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