Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 668
- 试验地点
- 8
- 主要终点
- Composite outcome: cup detachments (failure=3 detachments), other instrument used, caesarean section, caput succedaneum, cephalohaematoma, maternal perineal lesions. If one of these criteria at least is present, outcome is noted 'failure'; else 'success'
研究概览
简要总结
The hypothesis is that the new vacuum assisted delivery device iCup is more effective than the reference cup, in terms of maternal and newborn morbidities and functioning
详细描述
Currently, instrumental extractions are used in about 10% to 15% of the 860 000 annual deliveries in France and the use of vacuum extractors increases from year to year. In addition to sterilizable vacuum extractors several different types of vacuum extractor have been developed, in particular the single use Kiwi cup or the so-called 'soft' cup extractors. However, studies evaluating these new cups have not shown their superiority in comparison to the conventional metallic vacuum extractor.
Accordingly, it is legitimate to assess the new vacuum extractor iCup, an innovative "mix" of metallic cup and 'soft' cups that should combine the advantages of both; and to compare the iCup vacuum extractor with the sterilizable metallic cup extractor, the most effective vacuum extractors available to date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •maternal age between 18 and 45 years old
- •singleton delivery after 37 weeks, in cephalic presentation,
- •indication of vacuum extraction,
- •affiliation to the french social security system or equivalent
排除标准
- •no informed consent
- •singleton delivery before 37 weeks, in non-cephalic presentation,
- •patient deprived of freedom
结局指标
主要结局
Composite outcome: cup detachments (failure=3 detachments), other instrument used, caesarean section, caput succedaneum, cephalohaematoma, maternal perineal lesions. If one of these criteria at least is present, outcome is noted 'failure'; else 'success'
时间窗: one day
次要结局
- maternal lesions: cervix lesions, postpartum haemorrhage(28 days maximum)
- neonatal lesions: minor scalp injuries, Apgar score < 7, pH < 7.20, anaemia, jaundice, transfer(28 days maximum)
- medico-economic criteria: cost-effectiveness analysis of the studied medical devices(28 days maximum)
研究者
AdministrateurCIC
Dr Véronique EQUY, University Hospital, Grenoble.
University Hospital, Grenoble