EUCTR2014-004445-26-GB进行中（未招募）1 期
A phase III, randomized, double-blind, active, controlled, multinational, multicentre, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30,000
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
- •Participants will be eligible for the trial if:
- •1.They are expected to deliver vaginally
- •2.They have a cervical dilatation equal to or less than 6cm
- •3.They have a known singleton pregnancy
- •4.They provide written informed consent before any trial-related procedures are carried out.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1290
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28710
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participants will be excluded from participating in the trial if they are/have:
- •1.In an advanced first stage of labour (>6 cm cervical dilatation) or too distressed to understand, confirm and give informed consent regardless of cervical dilatation
- •2.Non-emancipated minors (as per local regulations) without a guardian
- •3.Scheduled for a planned caesarean section
- •4.A birth considered as an abortion according to local guidelines
- •5.Known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial
- •6.Serious cardiovascular disorders
- •7.Not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder.
研究者
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