NCT04452747已完成不适用
Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Clinical Trial of Two Strategies (DINO-FIRST Versus BALLON-FIRST)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Rate of vaginal deliveries
研究概览
简要总结
Labour induction is an obstetrical procedure, which artificially starts the process of cervix dilation, in order to induce labour. Several methods of labour induction exist : mechanical ones (using dilatation balloons) or pharmacological ones (using prostaglandins or oxytocin). This trial aims to compare, in case of non-favourable cervix, the strategy of labour induction using the Propess® method first (Dino-first) versus the strategy beginning with the use of a dilatation balloon (Ballon-first), with respect of the usual practice and the current guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with singleton pregnancy
- •Fetus with cephalic presentation
- •Intact membranes between 37 and 42 weeks of amenorrhea
- •Medical indication for labour induction according to the "Haute Autorité de Santé" (HAS) guidelines
- •Unfavourable cervix (Bishop scoring < 7)
- •Age > 18 years-old
- •Person affiliated to a healthcare system
- •Good understanding of the French language
排除标准
- •Previous C-section or uterine incision
- •Placenta previa
- •Metrorrhagia of unknown origin
- •Lethal foetal abnormality
- •Hyperreactivity to one of the molecules used for the induction (dinoprostone or oxytocin) or to latex
- •Subject participants to another biomedical research
- •Subject under legal guardianship or curatorship
研究组 & 干预措施
Dino-first
Active Comparator
Labour will be induced by the use of the vaginal Dinoprostone system (Propess®) first.
干预措施: Vaginal Dinoprostone system (Propess®) (Procedure)
Balloon-first
Active Comparator
Labour will be induced by the use of a cervix dilatation balloon first.
干预措施: Dilatation balloon (Procedure)
结局指标
主要结局
Rate of vaginal deliveries
时间窗: On the day of the delivery
Rate of vaginal deliveries (both spontaneous or instrumentally assisted)
次要结局
- Rate of uterine rupture(On the day of the delivery)
- Rate of neonatal asphyxia(On the day of the delivery)
- Rate of labour induction failure(On the day of the delivery)
- Rate of hospitalization in Neonatal intensive care unit(Up to four days after the delivery)
- Pain level recorded at different times of the labour induction(On the day of the delivery)
- Rate of spontaneous vaginal deliveries(On the day of the delivery)
- Rate of secondary or tertiary use of Propess, Foley catheter of intra-veinous oxytocin(On the day of the delivery)
- Rate of instrumentally assisted vaginal deliveries, including the reason for the assistance(On the day of the delivery)
- Rate of C-section including the reason for the C-section(On the day of the delivery)
- Timeframe between the beginning of the induction and the beginning of the labour(On the day of the delivery)
- Cumulated rate of spontaneous vaginal deliveries(at 12 hours, 24 hours and 48 hours)
- Rate of peridural anaesthesia during labour(On the day of the delivery)
- Rate of uterine hyperstimulation with an impact on the foetus(On the day of the delivery)
- Rate of metrorrhagias while putting in place the dilatation balloon or the vaginal pad (dinoprostone)(On the day of the delivery)
- Assessment of the patient experience of the labour induction(Up to two weeks after the delivery)
- Assessment of each strategy direct main costs(through study completion, an average of 3 years)
- Rate of uterine hyperstimulation without impact on the foetus(On the day of the delivery)
- Rate of uterine hypertonia(On the day of the delivery)
- Rate of post-partum haemorrhagia(On the day of the delivery)
- Pain level linked to the inflation of the dilatation balloon and requiring the partial deflation of the balloon(On the day of the delivery)
- Rate of intra-uterine infections(On the day of the delivery)
- Rate of post-partum infections(One week after day of the delivery)
- Rate of proven bacteriological infections in newborn babies(Up to four days after the delivery)
研究者
研究点 (2)
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