CTRI/2016/05/006969已完成3 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 - CHAMPIO
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7,098
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Trial participants will be pregnant women coming to the hospital for delivery.
- •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
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
- •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.Known cardiovascular disorders
- •7.Known hepatic or renal disease
- •8.Epilepsy
- •9.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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