International Observational E-Registry on the Use of Dilapan-S / Dilasoft Osmotic Dilators for Cervical Ripening Prior to Labour Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 11
- 主要终点
- Rate of vaginal deliveries within 24 hours
研究概览
简要总结
International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.
详细描述
International Observational E-Registry to monitor current common clinical practice of use of Dilapan-S / Dilasoft for cervical ripening and following procedures of labour induction with the main focus on the duration of induced labor procedure .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Indication for induction of labor
- •Unfavourable cervix
排除标准
- •Presence of overt genital tract infection
结局指标
主要结局
Rate of vaginal deliveries within 24 hours
时间窗: up to 24 hrs
Rate of vaginal deliveries achieved within 24 hours from the beginning of induced labor procedure
Duration of Dilapan-S/Dilasoft insertion
时间窗: max. up to 24 hrs; estimated average 12 hrs)
duration of cervical ripening
Induction - delivery interval
时间窗: estimated maximum up to 72 hrs
Overall duration of induced labor procedure
次要结局
- % of Caesarean sections(estimated maximum up to 72 hrs)
- Bishop Score increase after extraction of osmotic dilators(up to 24 hrs; estimated average 12 hrs)
- % of instrumented vaginal deliveries(estimated maximum up to 72 hrs)
- Number of dilators inserted(up to 24 hrs; estimated average 12 hrs)
- Agents / procedures used for induction of labour, if any(estimated maximum up to 72 hrs)
- Maternal infectious complication and its relation to the use of Dilapan-S/Dilasoft(up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.)
- Complications during pre-induction(up to 24 hrs; estimated average 12 hrs)
- Foetal status(0, 5 and 10 minutes after delivery (estimated maximum up to 72 hrs))
- Type of osmotic dilator used: Dilapan-S or Dilasoft(up to 24 hrs; estimated average 12 hrs)
- % of spontaneous vaginal deliveries following immediately after pre-induction(up to 24 hrs)
- % of total spontaneous vaginal deliveries(estimated maximum up to 72 hrs)
- Neonatal infectious complication and its relation to the use of Dilapan-S/Dilasoft(up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.)