REgistry of MisOprostol 200 µg Vaginal dElivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Time to vaginal delivery of the neonate in hours
研究概览
简要总结
The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included. All directions for medication usage and patient monitoring are solely at the discretion of the investigator in accordance with their usual practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg VDS. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during induction of labour. No effort is expected from the study subjects. 150 patients from 20 Dutch centres will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated
- •Decision made to prescribe misoprostol 200 µg VDS according to Summary of Product Characteristics (SmPC)
- •Willingness and ability to provide written informed consent
排除标准
- •Misoprostol 200 µg VDS is contraindicated according to the SmPC
研究组 & 干预措施
Misoprostol 200 µg VDS
At the discretion of the investigator in accordance with their usual practice and consistent with the Dutch prescribing information.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Time to vaginal delivery of the neonate in hours
时间窗: From insertion until vaginal delivery
次要结局
未报告次要终点